Usual Activities Research Articles

Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke.

Ginkgo diterpene lactone meglumine (GDLM) could improve the functional outcome after acute ischemic stroke (AIS). This study aimed to investigate the efficacy of GDLM on the quality of life in patients with AIS in China. This is a post hoc analysis of Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke trial. The quality of life was measured using the EuroQoL questionnaire, including EQ-5D and EQ visual analogue scale (EQ-VAS). The primary outcomes were changes in EQ-5D and EQ-VAS from baseline to day 14 and day 90 after randomization. A total of 3219 patients with completed data on outcomes were enrolled, with median age of 63years (interquartile range, 55-70) and 2,067 (64.2%) men. GDLM was associated with a significant decrease in scores of ED-5Q components (from 0 [no problem] to 3[extreme problem]), the mean difference between GDLM and placebo group was -0.14 for mobility, -0.11 for usual activities and self-care, -0.09 for pain/discomfort, and -0.34 for anxiety/depression on day 14, respectively. Similar results were observed on day 90. Additionally, there was statistically significant difference of changes in EQ-VAS between the GDLM group and the placebo group from baseline to day 14 (mean difference, 1.70; 95% confidence interval [CI], 0.78-2.62; P = 0.0003) and to day 90 after randomization (mean difference, 3.29; 95% CI, 2.37-4.22; P < 0.001). In this analysis of Chinese patients with AIS, GDLM could improve the 14-day and 90-day quality of life compared with the placebo. URL: https://www. gov . Unique identifier: NCT02526225. Registration Date: 2016-02-01.

"Surviving the dip" after subacromial balloon spacer implantation for massive rotator cuff tear treatment: a retrospective case series.

Subacromial balloon spacer implantation (SBSI) attempts to decrease glenohumeral joint (GHJ) pain and improve function in patients with an irreparable rotator cuff tear (RCT) and minimal osteoarthritis. Between 12 and 26 weeks post-SBSI, gradual implant resorption may create a "balloon dip" that decreases GHJ function and increases pain. This retrospective cohort study attempted to delineate shoulder function, active mobility, strength, pain, and functional task impairment during the "balloon dip" period. Sixty-five consecutive patients (55.9 ± 7years of age, 42 men) with an irreparable RCT treated by the same fellowship-trained shoulder surgeon participated in this study. Outcome measurements pre-SBSI, during Phase I (early pain control ≤ 3weeks post-SBSI), Phase II (early rehabilitation > 3-11weeks post-SBSI), Phase III (advanced rehabilitation-early balloon resorption > 11-16weeks post-SBSI), Phase IV (early strength training > 16-24weeks post-SBSI), and Phase V (advanced strength training > 24weeks post-SBSI) included the American Shoulder and Elbow Society (ASES) score for perceived bilateral shoulder function, visual analog scale (VAS) surgical shoulder pain score, active mobility, and shoulder manual muscle strength testing (p ≤ 0.05). The mean final follow-up time was 40weeks (range = 24.1-89.7weeks). The surgical shoulder had higher ASES scores at Phase V than pre-SBSI. Surgical shoulder pain was less during Phase V than pre-SBSI. The surgical shoulder had greater flexion during Phase V than at Phase II or pre-SBSI, and greater external rotation (adducted) during Phases V-III than pre-SBSI. Peak shoulder internal rotation to level 12 (thoracic spinous process #10) occurred during Phase V. Peak shoulder flexor, external rotator, and internal rotator strength occurred during Phase V. During Phase I, most subjects were unable to sleep on their surgical shoulder, wash their back/do up their bra, reach a high shelf, or lift 10-lbs overhead. Tasks that were impaired during the "balloon dip" (between Phase III and V) were lifting 10-lbs overhead, reaching a high shelf, and doing normal work. By the end of Phase V, however, most subjects could perform each task with minimal or no difficulty. Surgical shoulder function improved and pain decreased, however, specific perceived functional task impairments remained. During the "balloon dip" phase, the perceived ability to lift 10 lbs above shoulder level, to reach a high shelf, and to do usual work activities were the most impaired tasks.

Switching treatment to cipaglucosidase alfa plus miglustat positively affects patient-reported outcome measures in patients with late-onset Pompe disease.

Late-onset Pompe disease (LOPD), a rare autosomal recessive multisystemic disorder, substantially impacts patients' day-to-day activities, outcomes, and health-related quality of life (HRQoL). The PROPEL trial compared cipaglucosidase alfa plus miglustat (cipa+mig) with alglucosidase alfa plus placebo (alg+pbo) in adult patients with LOPD over 52weeks and showed improved motor and respiratory function in patients switching treatment from standard-of-care enzyme replacement therapy (ERT) to cipa+mig at baseline. This study evaluated the impact of cipa+mig on patient-reported outcomes (PROs), including HRQoL in ERT-experienced patients, using data from PROPEL. PROs evaluated included the Subject's Global Impression of Change (SGIC), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a, PROMIS Fatigue Short Form 8a, Rasch-built Pompe-specific Activity (R-PAct), and European Quality of Life-5 Dimensions 5 Response Levels (EQ-5D-5L). The proportions of responders in the cipa+mig arm and the alg+pbo arm were compared via chi-squared or Fisher's exact test (patient-level responder analysis), and least squares (LS) mean differences were calculated for change from baseline at Week 52 of the PRO measures (group-level analysis). At Week 52, patient-level SGIC responder and group-level SGIC analyses favored cipa+mig compared with alg+pbo across all SGIC domains (e.g. 90 vs. 59% responders in the cipa+mig vs. the alg+pbo group for SGIC ability to move around; P = 0.0005; and LS mean difference 0.385; P = 0.02). Similarly, PROMIS Physical Function and Fatigue domains numerically favored cipa+mig in both analyses (e.g. 50 vs. 40% responders in the cipa+mig vs. alg+pbo arm for PROMIS Physical Function; P = 0.37; and LS mean difference 3.1; P = 0.11). R-PAct for both treatment groups was similar in the patient-level responder analysis, but numerically favored alg+pbo in the group-level analysis (35% responders in both arms; P = 0.95; and LS mean difference -0.8; P = 0.48). Self-care, usual activities, and depression/anxiety domains of EQ-5D-5L numerically favored cipa+mig in both analyses (e.g. 20 vs. 12% responders in the cipa+mig vs. alg+pbo arm for EQ-5D-5L self-care; P = 0.54; and LS mean difference -0.108; P = 0.52). Overall, switching treatment from alglucosidase alfa to cipa+mig positively impacted PRO measurements during the double-blind period of PROPEL. NCT03729362; Registration date: November 1, 2018; https://clinicaltrials.gov/study/NCT03729362.

Importance of Return to Usual and School Activities After Social Isolation in Recovering Vitamin D Concentrations, Physical Fitness, and Motor Performance in Adolescents

This study aimed to observe adolescents’ changes and individual responses regarding the anthropometry, cardiometabolic profile, vitamin D concentrations, physical fitness, and motor competence upon immediate return and three months of school activities after lockdown. Methods: The study included 28 adolescents (14.8 ± 0.8 years) of both sexes. Anthropometric measures, body composition, cardiometabolic parameters, physical fitness, and motor competence were assessed. A paired t-test was used to compare the frequencies of respondents and the effect size of the results, considering significant p &lt; 0.05. Results: After three months of school activities, adolescents changed their body composition, reducing % fat mass (p = 0.008) and increasing fat-free mass (p = 0.008). In terms of physical fitness, there was increased abdominal resistance (p &lt; 0.001; ES = −0.42) and motor performance, with reduction in supine-to-stand test time (p &lt; 0.001; ES = 0.53). There were very beneficial effects in reducing resting heart rate (p ≤ 0.001; ES = 0.61) and increasing vitamin D concentrations (p &lt; 0.001; ES = −0.61). After three months of a school routine, the proportions of change in respondents were similar between girls and boys and eutrophic individuals and overweight individuals. Conclusions: Returning to school activities after lockdown was important for the recovery of vitamin D concentrations, physical fitness, and motor competence, whose responses were independent of the level of adiposity and sex of the adolescents.

Health related outcomes of patients with serious traumatic injury: Results of a longitudinal follow-up program delivered by trauma clinicians

IntroductionThe routine collection of long-term patient health outcomes after serious traumatic injury at the health service level is uncommon. In 2019, we implemented the longitudinal Trauma Service Follow Up (TSFU) program at a level I trauma centre. Delivered by the trauma service clinicians involved in inpatient care, it assesses quality of life and disability. This study reports the 6- and 12-month outcomes of the first two years of operation of the TSFU program. MethodsThis is a prospective cohort study of seriously injured adult trauma patients admitted to a level I trauma centre with 6- and 12-months post-discharge outcome assessments. Outcomes were quality of life and function/disability as measured using the EQ-5D-5L and WHODAS 2.0 validated instruments. Changes from 6 to 12 months were assessed using generalised estimating equations methods. Logistic regression models were used to identify factors associated with ongoing problems at each time point. ResultsFive-hundred and eight seriously injured patients were eligible for the TSFU program with follow-up rates over 80 % at both 6- and 12-month timepoints. At six months, ongoing problems with pain (69.9 %), anxiety and depression (49 %) and carrying out usual activities (57.5 %) were highly prevalent; at 12 months problems with pain (61.4 %) and anxiety and depression (43.8 %) persisted. Lower extremity and/or pelvic surgery was associated with ongoing pain, odds ratio (OR) = 3.77 (95 % CI 1.54–9.21, p=0.01), anxiety and depression (OR 1.95, 95 % CI 1.09–3.48, p=0.02) and problems carrying out their usual activities (OR 3.19, 95 % CI 0.75–13.5, p=0.11) at six months. These patterns mostly persisted at 12 months. Similar associations between surgical intervention and high levels of disability were evident at both time points. ConclusionPersistent impairments in physical and emotional health continues to affect many people following serious traumatic injury. The collection of longitudinal health outcomes by trauma clinicians enables identification of factors that contribute to disability and a reduction in quality of life. This in turn can drive quality improvement initiatives within the hospital trauma system. Longitudinal follow-up programs may provide a platform to provide ongoing specialist trauma-informed care after hospital discharge.

Exploring Health-Related Quality of Life (HRQOL) among patients with HIV-associated TB in Khayelitsha, South Africa.

Health-related quality of life (HRQOL) is an important and frequently used patient-reported outcome in health research. However, little qualitative research exists in this field in South Africa. This study was set in Khayelitsha, one of the largest informal settlements in South Africa, where the burden of HIV and tuberculosis (TB) co-infection are amongst the highest in the world and significantly affect HRQOL. To explore the experience of HRQOL among patients living with HIV-associated TB. We conducted sixteen interviews with male (n = 10) and female (n = 6) adult participants (ages 24-56; median age 35) to explore their HRQOL living with HIV-associated TB, related treatment and how this impacted on life domains they considered relevant for HRQOL. We used thematic analysis to analyse data, using both an inductive and deductive analysis using an interpretive phenomenological approach (IPA). Experiences of HRQOL were identified along the predominantly emerging themes of physical, social, and mental aspects of HRQOL. Identified sub-themes included well-being, loss of strength, and self-care for the physical domain; usual activities and stigma for the social domain; concerns and coping for the mental domain. The findings illustrate that HRQOL domains are interconnected through social experience. The social experience of HRQOL was identified as the common denominator connecting all domains, around which HRQOL revolved for these participants. HRQOL is experienced socially. The interpersonal connections patients have with significant others present as key to high HRQOL among patients living with HIV-associated TB. This study adds to the existing literature of HRQOL and examines HRQOL using IPA which may help to inform future interventions to improve HRQOL among HIV/TB patients.

Persistent symptoms after COVID-19: an Australian stratified random health survey on long COVID.

To determine the impact of persistent symptoms after coronavirus disease 2019 (COVID-19) in an Australian population. We conducted a statewide health survey of a stratified random sample of adults who had had a confirmed acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19-positive group) and their close contacts (control group). The sample was drawn from Victoria's COVID-19 database between January 2020 and October 2022. Data were collected from 12 688 survey respondents between September 2022 and April 2023 (11 174 in the COVID-19-positive group and 1514 in the control group). Persistent new symptoms, recovery, and daily function using validated questionnaires for fatigue, neurocognitive symptoms, anxiety, depression and quality of life. At a mean of 12.6 months after infection, 4560 respondents in the COVID-19-positive group (39.1%; 95% CI, 37.9-40.3%) reported at least one persistent new symptom, compared with 216 respondents in the control group (20.8%; 95% CI, 18.5-23.1%). A total of 1656 respondents (14.2%; 95% CI, 13.4-15.0%) were classified as having clinical long COVID using the criteria of at least one persistent new symptom and less than 80% recovery three months after the infection. Of the respondents with clinical long COVID, 535 (3.2%; 95% CI, 2.6-3.8%) reported at least moderate problems with usual activities at 12 months after their infection. The proportion of respondents with clinical long COVID was lower for those with more recent infections. The risk factors for clinical long COVID were female sex, age 40-49 years, infection severity, chronic illness, and past anxiety or depression. Factors associated with a decreased risk of having clinical long COVID included infection when the Omicron strain was dominant and infection when the Delta strain was dominant, as compared with when the ancestral strain of the virus was dominant. Persistent symptoms after COVID-19 are common, though with a lower incidence following infection from less virulent strains. Although long COVID can be largely managed in primary care, a minority of people who have persistent symptoms and impaired function may require specialist care pathways, the effectiveness of which should be a focus of future research.

Physical training augmented with whole body electronic muscle stimulation favorably impacts cardiovascular biomarkers in healthy adults – A pilot randomized controlled trial

BackgroundPhysical activity is protective against cardiovascular disease (CVD) and favorably improves CVD risk profile. However, more than 25 % of American adults report no participation in physical activity. Whole body electronic muscle stimulation (WB-EMS) training is a novel FDA-cleared technology which offers a time-efficient and adaptable method for physical training by simultaneously stimulating the main muscle groups using percutaneous electrical impulse transmission. Studies have demonstrated increased muscle mass, reduced fat mass, and improved functional capacity in sedentary individuals after training with WB-EMS, but studies evaluating the role of WB-EMS training on CVD risk profile are lacking. MethodsWe performed a pilot randomized controlled trial in healthy adults randomized to physical training with versus without WB-EMS for one session of 20 min duration per week across 16-weeks. Study participants were asked to perform their usual activities but to abstain from any strength training during the study. During each training session, all study participants wore a specifically designed vest and arm and leg straps that were connected with electrical wires to the WB-EMS device (Miha Bodytec Gersthofen, Germany). Biphasic electrical stimulation was delivered through the vest and straps (4 s on, 4 s off) at a frequency that elicited a score of 5 or 6 on the Borg rating of perceived exertion scale from study participants when each of the following muscle groups was stimulated: thighs, buttocks, lower back, upper back, latissimus dorsi, abdomen, chest and arms. These frequencies were ‘titrated’ during the first 4 weeks and were then fixed at each muscle group for each participant. Individuals randomized to no WB-EMS wore the same equipment but received no electrical stimulation. Physical training sessions were provided by personal trainers certified for WB-EMS training and consisted of a fixed number of exercises and repetitions. We measured and compared several clinically important cardiovascular parameters at baseline and post-intervention. ResultsSeventy-eight participants were recruited between January 2021 and March 2022 with a mean age of 35.9 ± 11.2, 61.3 % females, median BMI 24.3 (21.8, 28.1); N = 46 were randomized to intervention group and N = 32 were randomized to the control group. Eighteen (23 %) participants dropped out of the trial, including 9 participants from the EMS arm (19.6 %), and 9 participants in control arm (28.1 %). There was no significant differences in the rate of dropping out of the WB-EMS and control groups (p = 0.27). Those in the intervention group compared to controls exhibited the following changes after 16-weeks of training: waist:hip ratio (∆ -0.03 ± 0.05, p = 0.01 vs. -0.01 ± 0.0, p = 0.1), peripheral endothelial function, measured using reactive hyperemia peripheral arterial tonometry (∆: 0.02 ± 0.1, p = 0.5 vs. -0.20 ± 0.3 p = 0.05), high-sensitivity C-reactive protein (∆: 0.06 ± 0.7, p = 0.3 vs. 0.20 ± 2.3 p = 0.02), total cholesterol (∆: −1.7 ± 25.1, p = 0.3 vs. 19.2 ± 26.5, p < 0.001), high density lipoprotein (∆: 2.02 ± 6.6, p = 0.2 vs. 3.6 ± 7.5 p = 0.01) and low density lipoprotein cholesterol (∆: 0.5 ± 26.7, p = 0.4 vs. 17.1 ± 23.2, p < 0.001). ConclusionOnce weekly physical training with WB-EMS in healthy adults resulted in either improved or stable biomarkers of cardiovascular risk, which either remained stable or worsened in those undergoing conventional training alone. Thus WB-EMS may provide an effective and time-efficient form of physical training that may be considered in those unable or unwilling to perform exercise conventionally.

Health-related quality of life and nutrient intake of the elderly with type 2 diabetes according to comorbidity burden: a cross-sectional study

Objectives: This study aimed to explore the cross-sectional association between health-related quality of life (HRQoL) according to the number of comorbidities in older adults with type 2 diabetes mellitus (T2DM) using the Euro Quality of Life-5 Dimensions (EQ-5D) index. Methods: This study included 3,553 participants aged ≥ 65 years from the 2008–2020 Korea National Health and Nutrition Examination Survey. Dietary data were collected through 24-hour recall interviews by trained researchers, and demographic and lifestyle information via self-administered questionnaires. HRQoL was measured using a modified EQ-5D scale. Multivariable linear regression analyzed the associations between EQ-5D scores, nutrients and comorbidity, controlling for sociodemographic and health variables. Results: Most participants reported ‘no problems’ in the EQ-5D scores, although approximately 17% to 47% of participants reported ‘some problems’ or ‘extreme problems,’ depending on the dimension. As comorbidities increased, significant declines were observed across all dimensions, particularly in mobility, usual activities, pain/discomfort, and anxiety/ depression. Nutrient intake analysis revealed that participants with three or more comorbidities consumed less carbohydrates, but more fat. Conclusion: Our findings demonstrate that among older adults with T2DM, a higher number of comorbidities is associated with decreased HRQoL. Additionally, there are differences in nutrient intake patterns among those with more comorbidities, specifically decreased carbohydrate intake and increased fat intake. These results emphasize the need for comprehensive and tailored management strategies that consider both diabetes and the co-occurring health conditions. By addressing the complex healthcare needs of individuals with multiple comorbidities, it is possible to enhance their HRQoL and overall well-being.

Evaluating the Effects of an 8-Week Zumba Exercise Program on Physical Fitness in Sedentary Women: A Randomized Controlled Trial

Objectives. This study aimed to evaluate the impact of an 8-week Zumba exercise program on physical fitness and body composition among sedentary women. The primary goals were to assess changes in muscle mass, flexibility, back strength, cardiovascular fitness, body weight, and body fat percentage. Materials and methods. Twenty-four female volunteers (mean age: 22.30 ± 2.10 years, height: 162.80 ± 4.00 cm) from North India were randomly assigned to either an experimental group, participating in a structured Zumba program (60-minute sessions, thrice weekly), or a control group, maintaining their usual activities. The initial and follow-up assessments comprised the measurement of height, weight, Body Fat Percentage (BFP), Body Muscle Mass (BMM), grip strength, back strength, flexibility, and Maximal Oxygen Consumption (VO₂max). Results. The statistical analysis conducted using the SPSS 26 software and the Wilcoxon Signed-Rank Test revealed significant improvements in the experimental group. Body weight decreased from 58.20 ± 5.10 kg to 56.80 ± 5.00 kg (p = 0.002), body fat percentage dropped from 25.10 ± 5.80% to 23.80 ± 6.00% (p = 0.03), and body muscle mass increased from 20.40 ± 3.20 kg to 21.00 ± 3.30 kg (p = 0.04). Grip strength improved from 32.50 ± 5.00 kg to 33.20 ± 4.80 kg (p = 0.05), back strength rose from 85.00 ± 22.00 kg to 105.00 ± 25.00 kg (p = 0.001), flexibility increased from 31.00 ± 2.80 cm to 34.00 ± 2.50 cm (p = 0.002), and VO₂Max increased from 41.00 ± 5.00 ml/kg/min to 44.00 ± 4.50 ml/kg/min (p = 0.001). No significant changes were observed in the control group. Conclusions. The 8-week Zumba program significantly enhanced physical fitness and body composition in sedentary women, improving muscle mass, flexibility, back strength, and cardiovascular fitness. These findings support Zumba as an effective and enjoyable exercise option, promoting an active lifestyle and better health outcomes, reinforcing its role as a comprehensive fitness solution suitable for encouraging sustained physical activity.

Trajectory of health-related quality of life during and after hospitalisation due to worsening of heart failure.

This study aimed to examine the trajectory in health-related quality of life (HRQoL) during and after hospitalisation for worsening of heart failure (HF) in Malaysia. 200 patients with heart failure and reduced ejection fraction (HFrEF) admitted into two hospitals in Malaysia due to worsening of HF were surveyed using the EQ-5D-5L questionnaire. The primary outcomes were utility values at admission, discharge and 1-month post-discharge (1MPD). Secondary outcomes included the visual analogue scores (VAS) and the proportion of patients reporting each EQ-5D-5L dimension levels. Missing data were imputed using multiple imputation, and generalised linear mixed models were fitted. At admission, the unadjusted mean utility values and VAS scores for HFrEF patients in Malaysia were as low as 0.150 ± 0.393 and 38.2 ± 20.8, respectively. After a median hospital stay of 4 days, there was a significant improvement in utility values and VAS scores by 0.510 (95% CI: 0.455-0.564) and 28.8 (95% CI: 25.5-32.1), respectively. The utility value and VAS score at 1-month post-discharge were not significantly different from discharge. The proportion of HFrEF patients reporting problems and severe problems in mobility, self-care, usual activities, and anxiety/depression, pain/discomfort reduced at varying degree from admission to discharge and 1MPD. HF is a progressive condition with substantial variation in HRQoL during the disease trajectory. During hospitalisation due to worsening of HF, HFrEF population has unfavourable HRQoL. Rapid and significant HRQoL improvement was observed at discharge, which sustained over one month. The study findings can inform future cost-effectiveness analyses and policies.

Quality of life of inflammatory bowel diseases patients in france with EQ-5D-5L: the QALY-MICI study.

This study aimed to document utility values and the Visual Analog Scale (VAS) with the 5-level version of the EQ-5D questionnaire in a large sample of patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). QALY-MICI was a cross-sectional survey across three sources in France. Data were collected between 2019 and 2022 for patients 18 and over. The EQ-5D-5L, the EQ-VAS, the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), the Harvey-Bradshaw Index (HBI) for CD, and the Walmsley Index for UC (SCCAI) were collected. A total of 2,841 patients aged over 18 were recruited (1785 with CD, 1056 with UC). The mean age was 40.2 (SD 14.3). The time since diagnosis was 6 years and over for 61.9% of patients. The most impacted dimensions were usual activities, anxiety/ depression, and pain/ discomfort. The mean utility value was 0.863 (SD 0.172) versus 0.905 (SD 0.158) in the French population (p = 0.007). The mean VAS value was 68 (SD 19.2) versus 73.4 (SD 22.2) in the general population (p = 0.016). Utility values and VAS were similar for CD and UC and higher for men. There was a strong positive correlation between utility values, the VAS, and the SIBDQ score, and a negative correlation between the HBI and the SCCAI. The SIBDQ score and disease activity were the main predictors of utility and VAS. The QALY-MICI is, to our knowledge, the first study documenting utility values and VAS using the EQ-5D-5L questionnaire on a large sample, with a comparison to the general population.

Effectiveness of a school-based high-intensity interval training intervention in adolescents: study protocol of the PRO-HIIT cluster randomised controlled trial.

High-intensity interval training (HIIT) is an effective strategy for improving a variety of health and fitness outcomes within school settings. Incorporating HIIT into existing physical activity opportunities appears practically feasible, yet the process evaluation and effectiveness of this strategy needs to be further evaluated. Therefore, a PRO-HIIT intervention will be conducted to evaluate the effectiveness of a 12-week school-based HIIT intervention on cardiorespiratory fitness, physical activity, body composition, muscular strength, bone health, cognitive function, wellbeing and academic performance among 12-13-year-olds. Eight classes of year 7 students (12-13-year-olds) from a secondary school in Ningbo, China, will be recruited and randomly allocated into an intervention or control group. While the control group maintains their usual activities, a 6 to 10 min HIIT session will be embedded in the physical education or physical activity lessons five days a week for 12 weeks for the intervention group. Training workshops will be conducted for participants, teachers, and research staff for facilitating the intervention. Outcome data will be collected at three time points: pre- and post-intervention, and two months (summer holiday) upon completion of the intervention. Linear mixed models will be used to analyse the impact of groups (intervention and control), timepoints (pre-, post- and two-month after intervention) and group by time interactions. The implementation process of the intervention will be evaluated using a process evaluation framework. Ethics approval is obtained from the Ningbo University Ethics Committee (TY2024002). Results from PRO-HIIT study will be disseminated via peer-reviewed journals, scientific conferences as well as local education system. The study protocol has been retrospectively registered on ClinicalTrials.gov Protocol Registration and Results System (NCT06374732), https://clinicaltrials.gov/study/NCT06374732.

Health-related quality of life and long-term incidence of major adverse events in patients with acute coronary syndromes

Abstract Background Assessing health-related quality of life (HRQoL) in patients with acute coronary syndromes (ACS) could provide insight into predicting major adverse cardiovascular events (MACE) and all-cause death. Purpose To investigate the association of baseline HRQoL and its change within the first year post-ACS with the incidence of MACE and all-cause death. Methods Participants in the SPUM-ACS study, a multicenter cohort of patients hospitalized for ACS at four Swiss university hospitals from 2007 and 2021 and followed-up for a median duration of 6.6 years, were evaluated for HRQoL at baseline and one-year post-discharge using the EQ-5D-3L index and visual analogue scale (VAS). The EQ-5D-3L index is derived from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Baseline HRQoL and its change within the first year post-ACS, alongside the individual health dimensions, were analyzed in relation to the risk of subsequent MACE (composite of myocardial infarction, stroke or transient ischemic attack, coronary revascularization, and cardiovascular death) and all-cause death using Cox proportional hazards models, adjusting for sociodemographic, lifestyle factors, and medical history. Results 2499 patients with ACS (mean age 62±12 years, 80% males), primarily undergoing percutaneous coronary revascularization, were included. Over a median follow-up of 6.6 years, 25% experienced MACE and 13% died from any cause. Overall, HRQoL improved in the first year post-ACS, with the EQ-5D-3L index increasing from 0.74 to 0.81 and the VAS from 68 to 76 (p&amp;lt;0.001). At baseline, 80% reported some problem in at least one health dimension, mainly anxiety/depression (36%), pain/discomfort (35%), and mobility (27%). By the first year, 58% had no problem or improved in one or more dimensions; however, 38% declined in at least one dimension, particularly in pain/discomfort (26%), or anxiety/depression (16%). The baseline VAS, but not EQ-5D-3L index, was inversely associated with the hazard of subsequent MACE and all-cause death (HR=1.06 [1.01, 1.11] per 0.1-unit and 1.10 [1.03, 1.19] per 10-unit decrease, respectively). Problems with pain/discomfort were associated with MACE (HR=1.20 [1.00, 1.44]); and mobility, self-care and usual activities with all-cause death (HR=1.36 [1.04, 1.79], 1.44 [1.04, 1.98] and 1.37 [1.04, 1.80], respectively) (Figure 1). First-year EQ-5D-3L index and VAS change were inversely associated with the hazard of MACE (HR=1.11 [1.04, 1.18] per 0.1-unit and 1.16 [1.07, 1.25] per 10-unit decrease) and all-cause death (HR=1.13 [1.04, 1.23] per 0.1 and 1.17 [1.06, 1.30] per 10-unit decrease, respectively) (Figure 2). Conclusion HRQoL at baseline and its change within the first year after ACS are associated with the risk of adverse events, suggesting HRQoL might be a valuable predictive indicator for long-term outcomes in patients with ACS.Figure 1Figure 2

Assessment of quality of life using EuroQol 5-Dimension questionnaire level sum score in patients with HFrEF, HFmrEF, and HFpEF: a patient-level meta-analysis of DAPA-HF and DELIVER

Abstract Background The impact of SGLT2 inhibitors on generic quality of life in heart failure (HF) has not been evaluated. Purpose To quantify individual dimension scores and the Level Sum Score of the EQ-5D-5L (EQ-5D-LSS) in patients with HFrEF and HFmrEF/HFpEF, the association between these scores and outcomes, and the impact of treatment with dapagliflozin on these scores. Methods The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). All dimensions and severity levels contribute equally when calculating the LSS. The individual dimension scores and the LSS were analyzed in patients with HFrEF and HFmrEF/HFpEF in the DAPA-HF and DELIVER trials, which compared dapagliflozin to placebo. Results Scores varied markedly by question with 37/30/33% of patients reporting no, a slight, or a moderate or greater problem for mobility; 67/20/13% for self-care; 40/33/27% for usual activities; 45/32/23% for pain/discomfort; and 57/27/16% for anxiety/depression. Compared to lower (better) LSS, patients with higher (worse) LSS were more often female, had more comorbidities, and had worse HF status. Compared to patients free from any problem across all dimensions (i.e. LSS of 5), the hazard ratios (95% CI) for time to first cardiovascular death or worsening HF were 1.27 (1.10-1.47), 1.70 (1.46-1.98), and 2.31 (1.88-2.85) in those with LSSs of 6-10, 11-15, 16-25 points, respectively. Patients randomized to dapagliflozin experienced greater improvement and less worsening across all EQ-5D-5L dimensions except pain/discomfort (Figure). Conclusions The EQ-5D-5L individual dimension questions revealed problems not often associated with (pain) or quantified in (anxiety/depression) HF and demonstrated the marked limitation of ordinary activities experienced by many patients with HF. Most EQ-5D-5L domain questions, including anxiety/depression, improved with dapagliflozin. The LSS, incorporating these domains was associated with clinical outcomes.

The Effect of a Biofeedback-Based Integrated Intervention for Older Adults with Orthostatic Hypotension: A Secondary Analysis on Psychological Health Outcomes in a Non-Randomized Pilot Trial.

Aging-related physical changes and dysfunctions in the autonomic nervous system (ANS) often lead to orthostatic hypotension (OH) in older adults. OH negatively impacts both the physical and psychological well-being of those affected. Previous studies have demonstrated that the biofeedback-based integrated program (BBIP), a multicomponent intervention focused on heart rate variability biofeedback, effectively improves OH, as well as symptoms related to ANS function. This substudy aims to examine the effects of the BBIP on psychological health outcomes among community-dwelling older adults with OH. This study employed a non-randomized controlled trial design with a convenience sampling strategy. A total of 51 older adults with OH were recruited from two senior welfare centers and randomly assigned to either the intervention group (n = 27) or the control group (n = 24). The intervention group participated in a 12-week BBIP, which included weekly biofeedback sessions and group education on lifestyle modification to alleviate OH. Telephone counseling was also provided to promote compliance. The intervention group showed significant improvements in health-related quality of life, depression, anxiety, and fall efficacy after the 12-week BBIP, whereas the control group exhibited no significant changes. There was a significant reduction in the percentage of participants in the intervention group reporting problems in all five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The BBIP was effective in improving the psychological health outcomes of older adults with OH. Future studies should explore the long-term effects of the BBIP using a larger sample size and a randomized controlled trial design.

Quality of life after screening for atrial fibrillation: a substudy from a randomised screening trial

Abstract Background Screening for atrial fibrillation (AF) is rising, yet trials have failed to show efficacy for stroke prevention from screening and subsequent anticoagulation. Quality of life is an important outcome for patients and physicians, however, it is largely unknown how this outcome is affected by screening for AF. The adverse effects of screening should be considered before implementing systematic screening. Purpose To explore changes in quality of life associated with screening for AF and subsequent anticoagulant treatment upon AF detection. Methods We used quality of life data from 6,004 persons with stroke risk factors randomised to usual care (n=4,503) or screening for AF using implantable loop recorder and anticoagulation for AF episodes lasting ≥6 minutes (n=1,501). The validated EQ-5D-5L tool evaluates health-related quality of life in five domains (mobility, selfcare, usual activities, pain/discomfort and anxiety/depression), rendering a final score in EQ-index (worst=-0.76 best=1.00) combined with an EQ-VAS score (worst=0, best=100). EQ-index and EQ-VAS were analysed with linear mixed models from baseline through year three. The domains were also analysed with logistic regression to report the risk of major problems (defined as a rating of 3, 4, or 5 in the range [1-5], where 1 corresponds to no problem and 5 corresponds to an extreme problem within a given domain) overall and separately. Sensitivity analyses with imputation for missing data were performed. Results Data were available for 5,162 (86.0%) participants at baseline and in year three, and 227 (5.0%) in usual care and 65 (4.3%) in the screened group had died before the last assessment. At baseline, 1,202 of 5,162 (23.3%) participants reported major pain/discomfort problems, and 666 of 5,162 (12.9%) reported major mobility problems (Figure 1). Major selfcare problems were the least frequent problem reported by 83 of 5,162 participants (1.6%). The occurrence of major problems was increased after 3 years in all domains and in both randomisation groups, with a 2% higher occurrence of major pain/discomfort in the control group compared to the screened group. At baseline, the average EQ-index was 0.88 (±0.16) and EQ-VAS 78.4 (±16.2). After three years, the EQ-index decreased by -0.05 (-0.05; -0.04), p&amp;lt;0.0001 in the control group vs. -0.04 (-0.05; -0.02) in the screened group and EQ-VAS with -6.06 (-6.54; -5.57) in the control group vs. -5.18 (-6.52; -3.78) in the screened group, resulting in no statistically significant difference between the groups (p=0.063 and p=0.056) (Figure 2). The screened group was equally likely to report at least one major problem in quality of life after three years (odds ratio 0.93 (0.77;1.13)), but was less likely to report major pain/discomfort (odds ratio 0.84 (0.72;0.98)), compared with the control group. Conclusion Systematic and intensive screening for atrial fibrillation did not improve quality of life compared to usual practice.

Sex-related differences in health-related quality-of-life measured using the EuroQol 5-Dimension questionnaire across the LVEF spectrum in DAPA-HF and DELIVER

Abstract Background Although sex-related differences in response to disease-specific health-related quality-of-life (HRQL) instruments such as the KCCQ have been investigated in patients with heart failure (HF), this is not the case for generic HRQL instruments. Purpose To assess the sex-specific differences in health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) in patients with HF with reduced and mildly reduced or preserved ejection fraction (HFrEF and HFmrEF/HFpEF), and to assess the effect of dapagliflozin on EQ-5D-5L index scores. Methods Using patient-level data from the DAPA-HF and DELIVER trials comparing dapagliflozin to placebo, we analysed patient-reported outcomes for each dimension of the EQ-5D index scores between men and women. The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). Results Of 4744 patients with HFrEF, 4390 completed the EQ-5D-5L index scores (3408 men and 982 women, 77.6% vs. 22.4%). The correresponding numbes in 6263 patients with HFmrEF/HFpEF were 5745 overall and 3320 men vs. 2425 women (57.8% vs. 42.2%). Regardless of HF phenotype, women had significantly worse (lower) baseline index scores overall compared to men (0.849 vs. 0.899 in HFrEF and 0.844 vs. 0.884 in HFmrEF/HFpEF, both p&amp;lt;0.001). Although scores varied markedly by question, women generally had worse health status in all the dimensions as compared with men in patients with HFrEF (39% vs. 29% reporting a moderate or greater problem for mobility, 17% vs. 9% for self-care, 36% vs. 25% for usual activities, 29% vs. 19% for pain/discomfort, and 21% vs. 13% for anxiety/depression, all p&amp;lt;0.001) (Figure, top panel). A broadly similar pattern was observed in HFmrEF/HFpEF (Figure, bottom panel). In all patients, across the range of LVEF, there dapagliflozin led to a significant placebo corrected increase (improvement) in index score (0.008, 95% CI 0.002 to 0.014), with no interaction between sex and the effect of dapagliflozin (p for interaction with sex = 0.50). Conclusions Women reported significantly poorer health status in both HFrEF and HFmrEF/HFpEF compared to men. Dapagliflozin treatment improved EQ-5D index scores irrespective of sex across the range of ejection fraction. Figure Sex differences in the distribution of responses to EQ-5D-5L questionnaire. EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction.

Exploring health-related quality of life in Portuguese Informal Caregivers

Abstract Background Caregiving can be associated with several adverse health impacts, such as in terms of mental health, health services use, or health-related quality of life (HRQoL). This study assessed HRQoL levels in Portuguese Informal Caregivers, and their relationship with caregiver psychosocial characteristics (e.g., perceived general and mental health; perceived level of support) and caregiving circumstances (e.g., caregiving duration, caregiving hours). Methods A cross-sectional study was conducted through an online survey directed to informal caregivers. HRQoL was measured using the Portuguese translation of the EQ-5D-5L. This instrument yields two values for HRQoL: a health profile (EQvalue) covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a visual analogue scale (EQvas). Bivariate analyses were performed and results with p-values below 0.05 were considered statistically significant. Results A total of 760 informal caregivers were surveyed (mean age 57 years (±9.9), 92.5% female, 41.5% at least university level, 44.4% works full or part-time). The mean total score for EQvalue (n = 733) was 0.8 (SD = 0.2). The mean total score for EQvas (n = 760) was 63.1 (SD = 21.5). The perceived general (p &amp;lt; 0.001) and mental (p &amp;lt; 0.001) health status, and the perceived access to healthcare (p &amp;lt; 0.001) were associated with EQvalue score. Also, EQvalue score was found to be directly correlated with the perceived level of support (r = 0.142; p &amp;lt; 0.001) and competence (r = 0,237; p &amp;lt; 0.001), and inversely correlated with the number of caregiving hours per day (r= -0,150; p = &amp;lt; 0,001) and the caregiving duration (r= -0,109; p = 0.008). Conclusions A significant relationship between caregiver HRQoL and several caregiver psychosocial variables was identified. Investing in and promoting the use of respite care services, as well as ensuring better access to healthcare for caregivers, appears important for improving caregivers’ HRQoL. Key messages • Improving caregivers’ access to healthcare and education or training programs (promoting a greater sense of competence) can be important in helping them maintain their quality of life. • Increasing the availability and promoting the use of respite care services by caregivers can be important in helping them maintain their quality of life.

Substantial morbidity and mortality due to cardiovascular diseases in hospitalized vaccinated and un-vaccinated patients with COVID-19 from 16 countries: the WHF COVID-19 Long-term study

Abstract Background Long-term adverse consequences of the COVID-19 affect many organ systems, and this requires the identification and appropriate care of diverse symptoms. Purpose The World Heart Federation (WHF) international study describes the burden of clinical sequelae of COVID-19 up to 1 year after hospitalization, including patients from low- middle-and high-income countries. Methods We prospectively recruited patients hospitalized due to COVID-19 from 16 countries between January 2022 and June 2023. Patients were followed up at 1, 3, 6, and 9-12 months after hospital discharge. A standardized questionnaire administered by telephone collected data on long COVID symptoms, quality of life using the EuroQol 5 Dimension scale (EQ-5D), and disease outcomes including new onset diabetes and hypertension, major adverse cardiovascular events (MACE), and mortality. We report a descriptive analysis including demographic characteristics and outcomes up to one year after initial hospitalization. Results Of 2504 patients, the majority were Asian (78%), and male (56%). Mean age was 59.2 years (SD 19.9). Low- and lower-middle-income country participants constituted 65% of the cohort, with upper middle-income and high-income representing 20% and 15%, respectively. Follow-up rate was complete for 86%. 55% had received at least two doses of COVID-19 vaccination. At 1 month, 63% reported at least one persistent symptom, which decreased to 28% at 9-12 months. Fatigue was reported by 45% at 1-month and 17% at final follow-up. Anxiety occurred in 20% and 9% at these respective timepoints, and breathlessness in 12% and 6%. At 9-12 months, moderate to severe impairment of usual activities as measured by EQ-5D occurred in 19%, anxiety/depression in 10%, and mobility problems in 10%. The most frequent post-discharge new-onset illnesses were pulmonary embolism (7%), kidney problems (4%), and hypertension (3%). In-hospital mortality was 4% (n=102), and a further 12% (265 patients) died by one-year. The most common cause was sudden cardiac death (59%), respiratory disease including pulmonary embolism (13%), and stroke (6%). Conclusions We observed a significant burden of post-COVID-19 complications with one fifth of patients with persistent difficulties in usual activities at one year. This underscores the urgent need to understand the underlying mechanisms for organ damage and death, and for targeted preventive strategies and proactive management approaches to reduce them.