12-week Program Research Articles

Telehealth pivotal response treatment parent training: A pilot study

ABSTRACT The purpose of this pilot study was to assess the feasibility, benefits, and acceptability of a telehealth Pivotal Response Treatment (PRT) parent training program. Autistic children (N = 21; 2–6 years) with language delay and their parents participated in the 12-week program. Parent-report measures and parent–child home videos were used to assess changes in parent PRT treatment adherence and child language. Changes in child affect were used to assess intervention acceptability. At the end of the program, treatment adherence improved, and children made more intelligible utterances. Child communication skills as measured by parent-report on several standardized questionnaires also improved. This study demonstrates the benefits of telehealth parent training for improving child language and parent PRT implementation. Our findings also provide preliminary evidence of PRT acceptability. Randomized controlled trials are an important next step to evaluate the impact of telehealth parent training as a tool for overcoming barriers to accessing intervention.

Effects of a 12-Week Mixed-Method Physical Exercise Program on Physical Fitness, Stress, Anxiety, and Quality of Life in Adolescents with Cerebral Palsy: A Case Series Study.

Although the health benefits related to physical exercise for adolescents with cerebral palsy (CP) have been recognized, studies indicate that individuals with CP at school age are less involved in physical activities than their typical peers and are twice as likely to engage in sedentary behaviors. Therefore, our study aims to investigate the effects of a physical exercise program on physical fitness, stress, anxiety, and quality-of-life variables. A total of 15 teenagers with ambulatory CP (n = 8 boys, n = 7 girls, between 12 and 18 years old; M = 14.35; SD = 1.76) completed a 12-week program based on a mixed-method approach with face-to-face and live online activities. The outcome measures were physical fitness, stress, anxiety, and quality of life. The 12-week exercise program resulted in gains in muscular strength, flexibility, and aerobic endurance tests, characterized by an increase in average walking speed and average VO2 max. There was also a significant change in the perception of emotional states of depression, anxiety, and stress reported by the participants. The program proved to be effective in physical fitness tests and perception of emotional states. Given the positive effects produced by the program, its design appears to meet the demands of adolescents with cerebral palsy.

A randomized clinical trial of emotional freedom techniques for chronic pain: Live versus self-paced delivery with 6-month follow-up.

Chronic pain represents a major global healthcare crisis, and current treatments are limited in effectiveness and safety. Emotional freedom techniques (EFTs) show promise as a potential psychological treatment. The current study investigated the effect of a randomized clinical trial of EFT for chronic pain in a sample of 147 adult chronic pain sufferers (89.9% female; mean 54.63 years). Participants engaged in a 6-week EFT programme (either online self-paced or in-person). The per-protocol analysis indicated pain severity and interference scores were significantly lower at the end of treatment for the EFT group compared to waitlist, and these were sustained at follow-up. There were no differences between the in-person or self-paced programmes at follow-up for pain severity and interference. Somatic symptoms were significantly lower after EFT, although no further differences at follow-up. Quality of life scores were significantly higher after EFT, which were sustained at follow-up, and no differences between two styles of programme. No significant effects were found for anxiety, depression, happiness or satisfaction with life across the 6-week programmes for either style of delivery or at follow-up. These are discussed in terms of clinical score meanings. Intent-to-treat analysis was consistent with the per-protocol analyses. Limitations of the study are identified and future directions are discussed. Findings offer early promise for EFT as a potentially effective pain management strategy, as well as support for online intervention without compromising treatment outcomes. An emerging body-based intervention for chronic pain may be a possible solution for remote clients who cannot attend in-person sessions. In this clinical trial Emotional Freedom Techniques (EFT) significantly reduced chronic pain severity and interference, and there were no differences between and online self-paced program toan online in-person EFT intervention. Both were equally effective, also enhancing quality of life without compromising outcomes. The results were significant at 6-month follow-up/. These findings highlight a body-based approach as a promising, accessible pain management strategy, and highlights that online programs may be part of the solution for chronic pain patients.

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

Background Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ‘Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial’, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James’s Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019

Effectiveness of Activity Supported Earthquake Awareness Education Program in Primary School Children: "I Know What I Need to Do, I'm Not Falling Even If We Shake" Project.

The objective of this study was to enhance the knowledge base of primary school children regarding earthquake preparedness through the implementation of an activity-based earthquake awareness education program. The study was conducted as pre-posttest semi-experimental design with one group of 333 children in a primary school between January and May 2024. A Descriptive Information Form and Earthquake Awareness Knowledge Level Form were the data collection tools. The children were provided with a 6-week (modules) education program. Measurements were made before and after the education. The mean age of the children was 7.16±0.73 years (6-9), 56.8% were girls, 43.2% were boys, and 25.8% were second-grade children. Earthquake Awareness Knowledge Level Form total score was higher after the education (18.31±1.52) than before (15.51±3.73) (t=-16.144, p<0.001). The study revealed an increase in children's knowledge regarding appropriate behaviors in the context of earthquakes, encompassing actions to be taken before, during, and after such events. Modular education and applied activities are effective in increasing children's knowledge levels in the context of teaching a concept such as earthquake preparedness, where the acquisition of life-based skills is of paramount importance.

Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial.

While sepsis, an exaggerated response to infection, can affect people of all age groups, it is more prevalent in middle-aged and older adults. Older adults suffer worse short-term and long-term outcomes than younger patients. Older sepsis survivors are commonly discharged to long-term acute care facilities, where they often die within 1 year. Those who return home from the hospital lose the momentum of physical function improvement after early inpatient rehabilitation, and often face exacerbation of comorbidities and decline in physical function. Additionally, patients who are discharged home often live at distant locations and are not able to commute to rehabilitation centers due to their poor health status. Therefore, remotely delivered exercise interventions tailored to this population hold promise to improve physical function safely and effectively after sepsis. However, this type of intervention has yet to be tested in this population. This study aims to assess the safety, feasibility, and ease of recruitment and retention of participants for a remotely delivered physical activity intervention for improving physical function in middle-aged and older sepsis survivors. The proposed intervention will be delivered through a digital health platform that comprises a patient-facing mobile app and a 12-week physical activity program specifically designed for middle-aged and older sepsis survivors with poor health status who may face challenges participating in traditional out-patient or community-based exercise interventions. This study is ongoing and plans to enroll 40 sepsis survivors aged 55 years and older who will be randomized to either a remotely delivered exercise intervention group or a control group (electronic health diary). Both groups will use a tablet containing the Health in Motion app (Blue Marble Health). The intervention group will receive a clinician-designed personalized avatar-guided home exercise program and reminders while the control group will self-report daily activities using the in-app health diary feature. This study is the first to use a home-based, remotely monitored 12-week exercise program to improve physical function in sepsis survivors. This study will evaluate the safety, feasibility, and efficacy, providing the necessary knowledge to design and calculate power for future larger trials. This study will provide important information for planning a future randomized clinical trial to test the efficacy of a remotely delivered exercise intervention in this high-risk population. ClinicalTrials.gov NCT05568511; https://clinicaltrials.gov/study/NCT05568511. DERR1-10.2196/60270.

Maintained cognitive gains after 10 weeks of cognitively engaging exercise via reducing body fat in overweight children

ABSTRACT This study aimed to determine whether the exercise-induced cognitive benefits persist after the interventions end and whether the persistence of cognitive gains following the intervention depends on the post-intervention exercise behaviour. Overweight children aged 10–12 years were enrolled in a 16-week afterschool program. During the first 10 weeks, children were randomised to receive the cognitively engaging movement games (CEMG) (N = 27) or the sedentary control (N = 27) interventions. During the subsequent 6-week post-intervention period, children self-selected either CEMG or sedentary activities daily. Perceptual discrimination performance, fitness, and body fat were measured before, immediately after, and 6-week after the intervention. Immediately after the intervention, the CEMG group improved aerobic capacity, muscular endurance, muscle power, body fat, and perceptual discrimination performance compared with the control group, and most of these benefits persisted after 6 weeks following the cessation of intervention. During the 6-week post-intervention period where CEMG and sedentary activities were both available, the CEMG group chose to engage in CEMG more frequently and with higher intensity on those days than the control group. The post-intervention exercise behaviours were positively related to the persistence of cognitive gains, and these associations were mediated through decreased body fat. Collectively, the 10-week CEMG intervention has positive effects not only on physical and cognitive outcomes, but also post-intervention self-selected exercise behaviours that may help maintain intervention-induced cognitive gains in overweight children. Future research controlling for factors impacting children’s behavioural choice and determining the differential effects of CEMG versus traditional exercise regimen is needed. Trial registration: Thai Clinical Trials Registry identifier: TCTR20220913006.

Impact of home-based exercise on residual kidney function in patients initiating peritoneal dialysis: A feasibility multicenter randomized controlled trial.

Although the impact of aerobic exercise (AE) and resistance training (RT) on peritoneal dialysis (PD) patients is well established, the impact of exercise programs on residual kidney function (RKF) has not been elucidated. Patients were randomly assigned to either the exercise (n = 25) or control groups (n = 30). Patients in the exercise group performed AE three times a week and RT twice a week at home for 24 weeks. The control group did not receive any specific intervention. The primary outcome was RKF, assessed by residual glomerular filtration rate (rGFR). Secondary outcomes included urinary protein levels, distance covered in the incremental shuttle walking test (ISWT), and glycated hemoglobin (HbA1c) percentages. Linear mixed-effects models showed no significant changes in mean rGFR between the exercise and control groups at 12 weeks (-0.40; 95% confidence interval (CI): -2.17, 1.36; p = 0.65) and at 24 weeks (0.65; 95% CI: -1.15, 2.45; p = 0.48). There was a trend toward improvement in mean urinary protein level and ISWT results, and a significant decrease in mean HbA1c percentage at 24 weeks in the exercise group (-1.07, 95% CI: -2.29, 0.15, p = 0.09; 37.7, 95% CI: -10.1, 85.5, p = 0.12; -0.57, 95% CI: -0.97, -0.18, p = 0.005, respectively) compared to the control group. The 24-week home-based exercise program did not demonstrate beneficial effects on RKF in incident PD patients. Nonetheless, it may have an impact on reducing urinary protein levels and HbA1c percentages.

Physical Activity in young female outpatients with BORderline personality Disorder (PABORD): a study protocol for a randomized controlled trial (RCT)

BackgroundCurrent treatments for mental disorders, like pharmacotherapy or psychological approaches, do not lead to full remission in all individuals. Physical activity (PA) is effective at improving psycho-physical health in major depressive and anxiety disorders. However, the efficacy of PA as an adjunctive treatment for borderline personality disorder (BPD) has not been studied. To date, there are no approved pharmacological treatments for this severe condition and limited accessibility to effective psychotherapeutic interventions. This study tests the efficacy of a structured PA programme as an additional treatment for BPD outpatients.MethodsThe PABORD is a randomised controlled trial for female outpatients (18–40 years) with a BPD diagnosis. The intervention group (n = 32) will participate in a 12-week structured PA programme supervised by a sport medicine physician and preceded by three psychoeducation sessions on healthy eating habits. The control group (n = 32) will receive a 12-week psychoeducation programme on PA, diet, and health risks of a sedentary lifestyle for a total of 8 sessions. The study aims to determine if the PA intervention is superior to the control in reducing BPD symptoms. Secondary aims include improving PA levels and physical and psychological health. Assessments will be conducted at baseline, post-intervention, and 3 months post-intervention.DiscussionThe structured PA programme is expected to outperform the control group in terms of health and PA outcomes at the end of the intervention. Repeated assessments will also help to identify psychosocial factors that influence PA maintenance. Findings will support the potential widespread implementation of PA programmes for BPD treatment.Trial registrationClinicalTrials.gov NCT06461104. Registered on 6 June 2024 {2a}.

Acceptability, feasibility and preliminary efficacy of the Peer-led Hub-and-Spoke Community Aphasia Group program

ABSTRACT Background Several programs addressing the long-term impacts of aphasia after stroke show promise. However, barriers restrict their implementation at scale. Hub-and-spoke models of care operate in several health contexts to reduce the health care costs associated with health professionals providing all direct services, and to improve the reach of services to communities at distance from the main service. We developed the Peer-led Hub-and-Spoke Community Aphasia Group (Peer-led HS CAG) program to address staff and service availability barriers. The Peer-led HS CAG organises service through a “Hub” of allied and mental health professionals, led by a speech pathologist, who provide consultative and occasional direct services to the aphasia group. The “spokes” are volunteers with and without aphasia, trained and supported by the “Hub” staff to facilitate groups in the community. Aims We aimed to investigate the feasibility, acceptability, and preliminary efficacy of the Peer-led HS CAG program to address long-term impacts of aphasia. Methods & Procedures In a Phase I, proof of concept, mixed methods design we utilised: (1) a pre-post observational quantitative design; (2) an embedded qualitative study using semi-structured in-depth interviews of group facilitators and participants. Four health professionals from speech pathology, psychology, art therapy, and music therapy formed the Hub. Four volunteers were trained as group facilitators over two, half-day sessions prior to the group programs commencing. The 12-week group programme was delivered twice in a community setting, consisting of weekly 2-hour sessions. Seven people with aphasia attended: four in programme one, three in program two. The group program consisted of four compulsory topic sessions and eight “members choice” sessions. Seven close others attended four of the twelve program sessions: two with their family members with aphasia; two with specific “hub” staff input. During the remaining eight weeks of the program close others chose whether to meet independently. Outcome measures were taken at four time points: 6 weeks pre-program; immediately pre-program; immediately after-program; 6-week follow up. Outcomes & Results Four participants showed clinically meaningful gains in communication-related quality of life and three in functional communication immediately post-program or at 6-week follow up. Qualitative interviews confirmed the feasibility and overall acceptability of the program. Close others requested additional sessions specific to their needs. Conclusions The Peer-led HS CAG program is a feasible and acceptable way to address the current lack of community aphasia groups. Future phase II and III research should explore the efficacy and costs of this model.

Investigation of the Effects Of ACE Gene Polymorphism on Athletic Performance in Active Adult Males

Studying genes associated with exercise-related physiological systems and metabolic pathways has proven to be an effective method for identifying genetic markers associated with enhanced athletic performance. One of the extensively studied genes in genetics is "Angiotensin I-converting enzyme (ACE)" which has a significant role in regulating blood pressure, plasma volume, and the development of cardiac and skeletal muscle. The objective of this study was to determine the different results and genetic variations in the effects of ACE gene polymorphisms on the performance of the 30m sprint test and the arrowhead agility drill test in active adult males after a 6-week training program. Following the manufacturer's instructions, genomic DNA was extracted from participant mouth swab samples using the Buccalyse DNA Extraction Kit from Isohelix. The Statistical Package for the Social Sciences (SPSS) 25 application was used to perform statistical analysis on the research data. The findings indicate that 45.7% of the participants possess the I/D genotype, 31.4% possess the I/I genotype, and 22.9% possess the D/D genotype. There was no notable disparity in the performance of the arrowhead agility test and the 30 m sprint test among the different genotype groups (p&lt;0.05). Our analysis revealed a lack of association between genetic variants and the values obtained from performance measurements in the test outcomes. Due to the involvement of various genes and variables, further research is needed to improve the predictability of approaches to ACE gene variations, considering their performance-enhancing benefits.

Bioavailable testosterone and androgen receptor activation, but not total testosterone, are associated with muscle mass and strength in females.

Testosterone, the major androgen, influences the reproductive and non-reproductive systems in males and females via binding to the androgen receptor (AR). Both circulating endogenous testosterone and muscle AR protein content are positively associated with muscle mass and strength in males, but there is no such evidence in females. Here, we tested whether circulating testosterone levels were associated with muscle mass, function, or the muscle anabolic response to resistance training in pre-menopausal females. Twenty-seven pre-menopausal, untrained females (aged 23.5 ± 4.8 years) underwent a 12-week resistance training programme. Muscle strength, size, power, and plasma and urine androgen hormone levels were measured. Skeletal muscle biopsies were collected before and after the training programme to quantify the effect of resistance training on AR content and nuclear localisation. Primary muscle cell lines were cultured from a subset (n=6) of the participants' biopsies and treated with testosterone to investigate its effect on myotube diameter, markers of muscle protein synthesis and AR cellular localisation. Physiological levels of total testosterone were not associated with muscle mass or strength at baseline or with the changes in muscle mass and strength that occurred in response to resistance training in our cohort of pre-menopausal females. In contrast, bioavailable testosterone and the proportion of nuclear-localised AR were positively associated with skeletal muscle mass and strength in pre-menopausal females. In vitro, supra-physiological doses of testosterone increased myocyte diameter, but this did not occur via the Akt/mTOR pathway as previously suggested. Instead, we show a marked increase in AR nuclear localisation with testosterone administration in vitro. KEY POINTS: Total circulating testosterone was not related to muscle mass or strength before or after resistance training in pre-menopausal females. Bioavailable testosterone was positively related to exercise-induced muscle hypertrophy in pre-menopausal females. In vivo nuclear localisation of the androgen receptor was positively related to muscle mass in pre-menopausal females at baseline, but not to resistance training-induced hypertrophy. Testosterone treatment induced androgen receptor nuclear translocation but did not induce mTOR signalling in primary skeletal myocytes cultured from pre-menopausal female muscle.

Addressing rural health disparities by optimizing “high-touch” intervention components in digital obesity treatment: The iREACH Rural study

BackgroundRural residents are more impacted by obesity and related comorbidities than their urban counterparts. Digital weight management interventions may produce meaningful weight loss among rural residents. ObjectivesThe iREACH Rural Study aims to identify “high-touch” component(s) that contribute to meaningful weight loss (≥1.5 kg) at 6-months, over and above what the 24-week core online program produces. Three treatment components are assessed: group video sessions (yes/no); self-monitoring feedback (counselor-crafted/pre-scripted, modular); and individual coaching calls (yes/no). DesignThe iREACH Rural Study is a factorial experiment (n = 616). MethodsParticipants receive up to 3 “high-touch” components (weekly synchronous facilitated group video sessions, weekly counselor-crafted self-monitoring feedback, and individual coaching calls) to determine which contribute meaningfully to 6-month weight loss. Participants complete assessments at baseline, 2 months, 6 months, and 12 months. Weight loss at 6 months (primary outcome) and 12 months (secondary outcome) is measured by Bluetooth-enabled scales. The study seeks to identify the weight loss approach for underserved rural residents which optimizes weight change outcomes and also examines costs associated with delivering different treatment constellations. SummaryThe iREACH Rural Study is the first of its kind to isolate digital weight loss intervention components to determine which meaningfully contribute to long-term weight loss among rural residing individuals. The results may be used to refine digital weight loss programs by enhancing their effectiveness to allow broad dissemination.

Feasibility and efficacy of adding high-intensity interval training to a multidisciplinary lifestyle intervention in children with obesity-a randomized controlled trial.

Multidisciplinary lifestyle interventions for children with obesity in Denmark often include recommendations regarding physical activity, but no structured exercise program. We hypothesized that adding high-intensity interval training (HIIT) to a multidisciplinary lifestyle intervention would improve BMI z-score (primary outcome), waist circumference, blood pressure, and health-related quality of life (HRQOL). This randomized controlled trial included 173 children and adolescents with obesity. Participants were allocated to 12-months lifestyle intervention (N = 83), or 12-month lifestyle intervention accompanied by a 12-week HIIT program (N = 90). HIIT consisted of three weekly sessions and included activities eliciting intensities >85% of maximal heart rate. Attendance rate for the 3-months HIIT intervention was 68.0 ± 23.2%. Dropout was lower in HIIT compared to control at three months (7.8% vs. 20.5%) and 12 months (26.5% vs 48.2%). Changes in BMI z-score did not differ between HIIT and control at 3 months (Mean Difference (MD): 0.01, 95% confidence interval (CI): -0.09; 0.12, P = 0.82) or 12 months (MD: 0.06, CI: -0.07;0.19, P = 0.34). Across randomization, BMI z-score was reduced by 0.11 (CI: 0.17; 0.06, P < 0.01) at 3 months and 0.20 (CI: 0.26;0.14, P < 0.01) at 12 months. At 3 months, HIIT experienced a greater increase in HRQOL of 2.73 (CI: 0.01;5.44, P = 0.05) in PedsQL Child total-score and 3.85 (CI: 0.96; 6.74, P < 0.01) in psychosocial health-score compared to control. At 12 months, PedsQL Child physical-score was reduced by 6.89 (CI: 10.97; 2.83, P < 0.01) in HIIT compared to control. No group differences or changes over time were found for waist circumference or blood pressure. Adding a 12-week HIIT program did not further augment the positive effects of a 12-month lifestyle intervention on BMI z-score. Adding HIIT improved HRQOL after 3 months, but reduced HRQOL at 12 months. Implementation of HIIT in community-based settings was feasible and showed positive effects on adherence to the lifestyle intervention.

¡Iniciando! la Adultez, a bilingual treatment program for Latino, autistic young adults and their Spanish-speaking parents: a pilot study

Objectives Latino young adults with autism spectrum disorder (ASD) face many challenges during the transition to adulthood, particularly regarding executive functioning (EF) and mental health symptom management. Latinos with ASD are particularly underserved, with existing supports often neglecting these critical areas. The study aims to evaluate a culturally and linguistically tailored intervention to better support Latino young adults by improving their adaptive functioning to enhance social outcomes and quality of life. Methods The culturally adapted and translated intervention, called ¡Iniciando! la Adultez, is a 12-week therapy program based on an evidence-based treatment (Launching! to Adulthood). The present study involved young adults with ASD (n = 26) and their Spanish-speaking parents (n = 38). Participants completed measures at baseline, mid-treatment, and post-treatment. Results The ¡Iniciando! la Adultez program led to significant improvements in social domains (e.g. cognition, motivation), and improvements in adaptive functioning, EF, quality of life, self-efficacy, and emotion regulation. Parental stress and caregiver burden, however, did not show significant changes. Conclusions Tailored, holistic interventions like ¡Iniciando! la Adultez are useful for supporting autistic young adults. These programs effectively address critical gaps in EF and mental health management, especially for Latino individuals, promoting better outcomes during the transition to adulthood.

Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance

BackgroundWithout provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest. MethodsWe proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial. ResultsA total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m2, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001. ConclusionResults from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.

Increasing digital equity to promote online smoking cessation program engagement among rural adults: a randomized controlled pilot trial

BackgroundCigarette smoking prevalence is higher for rural than urban adults, yet digital access to cessation programming is reduced. We aim to investigate digital access interventions to promote engagement with an online evidence-based cessation treatment (EBCT) program among rural adults.MethodsThis pilot trial used a pragmatic, three-arm, randomized, parallel-group design (ClinicalTrials.gov: NCT05209451). Inclusion criteria included being aged ≥18, Mayo Clinic Midwest patient, rural residency, and currently smokes cigarettes. All participants received an online, 12-week EBCT program and were randomized to receive one of three digital access interventions: print materials (control, n = 30); print materials + loaner iPad device with data plan coverage (n = 30); or print materials + loaner device + up to six, 15–20-minute motivational interviewing-based coaching calls to support technology needs (n = 30). A composite score of trial engagement (primary outcome) and self-reported smoking abstinence and use of EBCT resources (secondary outcomes) were assessed online at 4 and 12 weeks. Qualitative interviews were used to assess patient experience. Neither participants nor outcome assessors were blinded to group assignment.ResultsResults are reported for all 30 participants in each group. The average age of participants is 51.0 years and 61% are women. We show no significant arm differences for the trial engagement composite score (p = 0.30). We also find coaching support is significantly (p < 0.05) associated with enhanced smoking-related treatment response, including cigarette abstinence and use of EBCT resources, and participants reported positive experiences with the intervention.ConclusionsThe coaching intervention to support technology needs is acceptable and shows preliminary evidence of its efficacy in smoking-related treatment response. Further studies could refine and implement the coaching intervention for trial engagement and long-term cessation.

A Behavioral Change-Based Mobile Intervention for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance of Patients With Coronary Artery Disease: Controlled Trial.

Cardiac rehabilitation is known to reduce coronary artery disease (CAD) severity and symptoms, but adoption of a healthy postrehabilitation lifestyle remains challenging. Innovative eHealth solutions could help, but behavioral change-based eHealth maintenance programs for patients with CAD are scarce. RehaPlus+ aims to improve postrehabilitation outcomes with a personalized eHealth intervention built on behavioral change concepts emphasizing healthy lifestyle changes, especially regular physical activity (PA). This study aims to evaluate the effectiveness of the personalized eHealth program RehaPlus+ for promoting regular PA against usual care. A total of 169 patients with CAD who had undergone stent implantation or bypass surgery were recruited after completing center-based phase II rehabilitation. They were then divided, without blinding, into 2 groups using a quasi-experimental approach: a case manager-assisted 24-week eHealth program (RehaPlus+; n=84) and a conventional physician-assisted outpatient program (usual care; n=85). The study was designed as a noninferiority trial. RehaPlus+ participants received motivational messages twice weekly for 6 months, and the usual care group engaged in a 6-month outpatient program (twenty-four 90-minute strength and endurance training sessions). The primary outcomes, evaluated using the self-assessed Bewegungs- und Sportaktivität questionnaire, were regular PA (≥150 min/wk) and weekly activities of daily living (ADLs) 6 months after rehabilitation. Secondary outcomes involved PA during work and floors climbed weekly (measured by Bewegungs- und Sportaktivität questionnaire), psychological well-being (assessed by the 5-item World Health Organization Well-Being Index), cardiac self-efficacy, health-related quality of life (measured by the 36-Item Short Form Survey), and work ability (using the Work Ability Index). Data of 105 patients (RehaPlus+: n=44, 41.9%; usual care: n=61, 58.1%; male patients: n=80, 76.2%; female patients: n=25, 23.8%; mean age 56.0, SD 7.3 years) were available at the 6-month follow-up. At 6 months after discharge from phase II cardiac rehabilitation, the RehaPlus+ group exhibited 182 (SD 208) minutes per week of PA and the usual care group exhibited 119 (SD 175) minutes per week of PA (P=.15), with no interaction effect (P=.12). The RehaPlus+ group showed an ADL level of 443 (SD 538) minutes per week compared to the usual care group with 308 (SD 412) minutes per week at the 6-month follow-up, with no interaction effect (P=.84). The differences observed in PA and ADL levels between the RehaPlus+ and usual care groups were within the predefined 1-sided noninferiority margin, indicating that the RehaPlus+ intervention is not inferior to usual care based on these outcomes. There were no differences between the groups for all secondary outcomes (P>.05). RehaPlus+ is not inferior to the usual care program, as both groups improved PA and ADLs to a similar extent. These findings emphasize the potential of eHealth interventions to assist in maintaining healthy lifestyles after rehabilitation. ClinicalTrials.gov NCT06162793; https://clinicaltrials.gov/study/NCT06162793.

Effects of a 12-week aerobic dance programme on diastolic blood pressure in stage one hypertensive adults

Hypertension which impacts over 1.5 billion people globally is a crucial health challenge accountable for more than 10.8 million early deaths yearly. Our study used an experimental design to investigate the effects of aerobic dance programme on diastolic blood pressure levels in stage one hypertensive adults over a 12-week period. The study participants were randomly allocated into either the experimental or control groups. Diastolic blood pressure measurements were collected using a mercury sphygmomanometer at baseline and post programme. The 12-week aerobic dance programme entailed three 45-minute sessions per week, at a moderate intensity. The paired samples t-test was used to compare mean differences within the groups with the significance level set at P

Telerehabilitation Program Impact on Overactive Bladder Symptoms and Metabolic Health in Obese Women: a Randomized Controlled Trial

INTRODUCTION. Overactive bladder syndrome is caused by many factors including obesity, insulin resistance and poor dietary habits. Since it is a chronic disease and needs time to be treated, introducing telepilates in addition to Mediterranean diet would encourage better adherence and results to the treatment program. AIM. To assess the impact of a virtual group-based telerehabilitation program on overactive bladder symptoms and metabolic health in women with obesity. MATERIAL AND METHODS. Eighty obese women (BMI 30.0–34.9 kg/m2) between the ages of 35 and 45 were allocated into two equal groups, 40 for each: (A) supervised telepilates and (B) unsupervised telepilates. The supervised group participated in a 12-week Pilates workout program over videoconference platforms three times a week. Meanwhile, the unsupervised group only received four online meetings. The groups’ diet was the Mediterranean style. The Hemostatic Model of Insulin Resistance (HOMA-IR), body mass index (BMI), waist circumference (WC), Patient Perception of Urgency Scale (PPIUS), Overactive Bladder Questionnaire Short Form (OAB-q SF), and Telehealth Usability Scale (TUS) were measured. RESULTS AND DISCUSSION. The supervised telepilates group exhibited statistically significant amelioration of overactive bladder symptoms and a reduction in HOMA-IR (p 0.001), while the unsupervised telepilates group showed insignificant changes in these measures (p 0.05). Furthermore, the supervised telepilates group showed significantly greater reductions in BMI and WC (p 0.001) than the unsupervised telepilates group (p 0.05). Additionally, the supervised telegroup outperformed the unsupervised telegroup on all parameters of TUS (p 0.001) CONCLUSION. Women with obesity experienced decrease in overactive bladder symptoms and improved metabolic health after completing a 12-week telepilates training program.