Between-group Difference In Change Research Articles

The Impact of COVID-19 Surges in 2019-2021 on Patient-Reported Outcome Measures After Spine Surgery at an Academic Tertiary Referral Center in Taiwan: A Retrospective Observational Cohort Study.

AimLimited data are available on the impact of the coronavirus disease 2019 (COVID-19) pandemic on patient-reported outcome measures (PROMs) in patients who underwent spine surgery. In this study, we aimed to investigate the associations between the COVID-19 outbreak in Taiwan (May 2021) and PROMs in patients who underwent spine surgery.MethodWe retrospectively identified patients who underwent spine surgery during identical defined 6-week time-intervals (May 16 to June 30) in 2019, 2020, and 2021. PROMs, including visual analog scale (VAS) score for pain, Oswestry disability index (ODI), and EuroQol-5D (EQ-5D), were investigated before surgical intervention and at a 1-month follow-up. Relevant clinical information was collected from the electronic medical records of patients. Linear regression analysis was used to examine the association between the pandemic in 2021 (vs. 2019/2020) and the PROMs after adjusting for age, sex, and relevant clinical variables.ResultsThe number of patients who underwent spine surgery at our hospital during the identical defined 6-week time-intervals in 2019, 2020, and 2021 was 77, 70, and 48, respectively. The surgical intervention significantly improved VAS, ODI, and EQ-5D of the patients (1 month after surgery vs. before surgery, all p < 0.001) in all three study periods. However, there was a significant between-group difference in change from baseline in VAS (p = 0.002) and EQ-5D (p = 0.010). The decrease in VAS and increase in EQ-5D after surgery in 2021 were not as much as those in 2019 and 2020. The associations between the pandemic in 2021 (vs. 2019/2020) and changes in VAS (β coefficient 1.239; 95% confidence interval [CI] 0.355 to 2.124; p = 0.006) and EQ-5D (β coefficient, −0.095; 95% CI, −0.155 to −0.035; p = 0.002) after spine surgery were independent of relevant clinical factors.ConclusionThere was less improvement in short-term PROMs (VAS and EQ-5D) after spine surgery during the COVID-19 pandemic. Assessment of PROMs in surgical patients during a pandemic may be clinically relevant, and psychological support in this condition might help improve patients' outcomes.

Abstract P100: Changes In Adiponectin But Not Tnfα Predict Changes In Insulin Sensitivity Following Health Behavior Intervention Among Latino Youth

Background: Pediatric obesity is characterized by an imbalance in pro- and anti-inflammatory markers that are associated with cardiometabolic diseases. Adiponectin (Adpn), an anti-inflammatory marker, is associated with insulin sensitivity, while tumor necrosis factor-alpha (TNFα) has been associated with insulin resistance among youth with obesity. However, it is unknown whether longitudinal changes in Adpn or TNFα predict changes in insulin sensitivity among high-risk youth. Methods: A total of 73 Latino youth with obesity (age 13.3±1.4 y, Female 40.3%, BMIz 2.2±0.3) were enrolled in either a lifestyle intervention or usual care. Given that there were no between-group differences in changes in insulin sensitivity at 6-months, groups were combined for the present analysis. Fasting serum samples were used to measure high-molecular weight Adpn and TNFα before and after intervention. Insulin sensitivity was estimated by the whole-body insulin sensitivity index (WBISI) using insulin and glucose concentrations from a 75-g, 2-h oral glucose tolerance test. Baseline associations were analyzed using Pearson correlations. Linear regression was used to analyze whether changes in Adpn or TNFα predict changes in WBISI, adjusting for age, sex, and intervention assignment. Data from linear regressions are presented as betas (β) and standard errors (SE). Results: At baseline, WBISI was positively and significantly associated with Adpn (r=0.296, p=0.015) but not with TNFα (r=-0.171, p=0.168), adjusting for age and sex. Increases in Adpn were associated with increases in WBISI, whereby for every 1 μg/dL increase in Adpn, there was a 0.7 unit increase in WBISI (SE=0.3, p=0.027). Changes in TNFα did not significantly predict changes in WBISI (β=0.1, SE=0.5, p=0.915). Conclusion: Changes in Adpn but not TNFα were associated with changes in insulin sensitivity following intervention among Latino youth with obesity. Whether Adpn is the mechanism by which health behavior changes increase insulin sensitivity warrants further investigation among high-risk youth populations.

Comparing the efficacy of angiotensin receptor-neprilysin inhibitor and enalapril in acute anterior STEMI patients after primary percutaneous coronary intervention: a prospective randomized trial.

For patients with heart failure (HF), the effect of angiotensin receptor-neprilysin inhibitors (ARNIs, sacubitril/valsartan) on cardiac remodeling has been found to be superior to angiotensin-converting enzyme inhibitors (ACEI). However, little data have described the impact of early-initiation ARNI in patients with acute anterior ST-segment elevation myocardial infarction (STEMI). In this prospective, randomized, double-blind, parallel-group trial, we enrolled 131 anterior STEMI patients who were treated with primary percutaneous coronary intervention (PCI) between February 2019 and December 2019. All patients received standard STEMI management and were divided into 2 groups (ARNI/enalapril). Primary efficacy outcomes were the between-group difference in change (from baseline to 4-, 12-, and 24-week) in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, left ventricular ejection fraction (LVEF), and left ventricular end-systolic volumes and end-diastolic volumes (LVESV and LVEDV). Secondary outcomes were determined by a composite of death, reinfarction, outpatient HF or HF hospitalization, malignant arrhythmia, and stroke. Safety outcomes included worsening renal function, hypotension, hyperkalemia, angioedema and cough. We found that NT-proBNP concentration decreased more in the ARNI group than in the enalapril group [4 weeks: ratio of ARNI vs. enalapril 0.36, 95% confidence interval (CI): 0.24 to 0.52, P<0.001; 12 weeks: 0.54, 95% CI: 0.35 to 0.79, P<0.001; 24 weeks: 0.53, 95% CI: 0.32 to 0.83, P<0.001). When compared to the enalapril group, the ARNI group patients had a significant reduction in LVEDV (P<0.001) and LVESV (P<0.001), and an improvement in LVEF (P=0.011) at 24 weeks. Secondary outcomes occurred in 13 participants (20.3%) in the ARNI group and 22 participants (34.4%) in the enalapril group [hazard ratio (HR), 0.56; 95% CI: 0.28 to 1.12; P=0.102]. The incidence of outpatient HF or HF hospitalization in the ARNI group was significantly lower than that in the enalapril group (HR, 0.36; 95% CI: 0.14 to 0.94; P=0.037). There were no significant differences in the safety between the 2 groups. For patients with acute anterior STEMI undergoing primary PCI, early initiation of ARNI provided significant clinical benefits. Chinese Clinical Trial Registry (ChiCTR2100042944) registered on February 1, 2021.

Adherence, Efficacy, and Safety of Wearable Technology-Assisted Combined Home-Based Exercise in Chinese Patients With Ankylosing Spondylitis: Randomized Pilot Controlled Clinical Trial.

BackgroundClinical practice guidelines recommend that exercise is essential in the self-management of ankylosing spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be difficult and patients may decline participation, whereas effective home-based exercise interventions that do not require regular medical center visits are likely to be more accessible for AS patients.ObjectiveThe goal of the research was to investigate the adherence, efficacy, and safety of a wearable technology–assisted combined home-based exercise program in AS.MethodsThis was a 16-week investigator-initiated, assessor-blinded, randomized, pilot controlled trial conducted at Chinese People’s Liberation Army General Hospital. We enrolled patients with AS who had no regular exercise habits and had been stable in drug treatment for the preceding month. Patients were randomly assigned (1:1) using a computer algorithm. An exercise program consisting of moderate-intensity aerobic exercise and functional exercise was given to the patients in the intervention group. The exercise intensity was controlled by a Mio FUSE Heart Rate Monitor wristband, which uses photoplethysmography to measure heart rate. Patients in the control group received usual care. The primary outcome was the difference in the Ankylosing Spondylitis Disease Activity Score (ASDAS). The secondary outcomes were patient global assessment (PGA), physician global assessment (PhGA), total pain, nocturnal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BAS Functional Index (BASFI), BAS Metrology Index (BASMI), Spondyloarthritis International Society Health Index (ASAS HI), 36-item Short Form Survey (SF-36), maximal oxygen uptake (VO2) max, body composition, range of motion of joints, and muscle endurance tests. Retention rate, adherence rate, barriers to being active, and adverse events were also assessed.ResultsA total of 77 patients were screened, of whom 55 (71%) patients were enrolled; 2% (1/55) withdrew without treatment after randomization. Patients were assigned to the intervention (n=26) or control group (n=28). The median adherence rate of the prescribed exercise protocol was 84.2% (IQR 48.7%-97.9%). For the primary outcome, between-group difference of ASDAS was significant, favoring the intervention (–0.2, 95% CI –0.4 to 0.02, P=.03). For the secondary outcomes, significant between-group differences at 16 weeks were detected in PGA, PhGA, total pain, BASDAI, BASDAI-fatigue, BASDAI–spinal pain, BASDAI–morning stiffness intensity, BASFI, and BASMI. Moreover, the frequency of difficulty in ASAS HI-motivation at 16 weeks was less in the intervention group (P=.03). Between-group difference for change from baseline were also detected in VO2 max, SF-36, back extensor endurance test, and the range of motion of cervical lateral flexion at 16 weeks. Lack of time, energy, and willpower were the most distinct barriers to being active. Incidences of adverse events were similar between groups (P=.11).ConclusionsOur pilot study suggests that this technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS who have no exercise habit, with good adherence and safety profile.Trial RegistrationChinese Clinical Trial Registry ChiCTR1900024244; http://www.chictr.org.cn/showproj.aspx?proj=40176

Effectiveness of an adapted physical activity intervention for weight management in adolescents with intellectual disability: A randomized controlled trial.

To evaluate the effectiveness of a 9-month school-based adapted physical activity (APA) program for reducing weight among adolescents with intellectual disability (ID). In this randomized controlled trial, adolescents with ID, aged 12-18 years, who were overweight/or with obesity were randomly assigned into intervention and control groups. The APA intervention consisted of aerobic and resistance exercises with an overall moderate intensity and was delivered at a frequency of two sessions per week for 9months. Changes in body mass index (BMI, primary outcome) and changes in BMIz, weight, percent body fat, waist circumference and waist-to-height ratio (secondary outcomes) were examined using general linear models. In total 61 subjects (39 in the intervention and 22 in the control) completed the study and were included in the analyses. At 9months, the intervention group exhibited a reduced BMI of -0.66 kg/m2 (95% CI -1.06 to -0.25 kg/m2 , p=0.002), while a significant increase in BMI was observed in the control group. A significant post-intervention between-group difference in change in BMI (-1.31 kg/m2 [95% CI -1.99 to -0.63], p < 0.01) was found in favour of the intervention group. Similar results were also observed for all secondary outcomes. This study provides evidence that a 9-month APA intervention induced clinically meaningful effects on weight loss in adolescents with ID.

Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs Using Biological Measures.

Background: Educational kinesiology is a popular intervention that aims to improve brain functioning via physical movements. Yet, it lacks supporting scientific evidence and is regarded as pseudoscience. Given the popularity of educational kinesiology in school settings, it is important to revisit its effectiveness through scientific research. Previous studies that evaluated the effectiveness of educational kinesiology relied mainly on subjective measures, in which subjective bias is inevitable. Cortisol and oxytocin levels in saliva have been reported to be reliable stress and anxiety markers that provide unbiased objective data. This study explores the effect of educational kinesiology on the changes in salivary cortisol and oxytocin levels in kindergarteners with special needs.Methods: A quasi-experimental design was adopted in this study. Thirty-seven kindergarteners (3.5–6.5 years old) who were either diagnosed with one type of special needs or referred by school principals due to the requirement of special supports at school were assigned to either the intervention group, which received 1-h educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Saliva samples were collected at baseline and after the completion of intervention programme for the measurement of cortisol and oxytocin levels. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC) were also collected at pre- and post-intervention. Because of the small samples, non-parametric tests such as Mann-Whitney U test, Quade test, and Fisher's exact tests were used in this study where appropriate.Results: After controlled for the effect at baseline, gender and types of special needs, the changes in oxytocin levels were significantly higher in the intervention group compared with control [F(1, 35) = 4.747, p = 0.036, eta2 = 0.119], whereas no significant between-group difference in changes of cortisol levels was observed [F(1, 35) = 0.306, p = 0.584, eta2 = 0.009]. Results from PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (p = 0.048, ϕ = 0.344, p = 0.037).Conclusions: Our findings suggest a plausible anti-anxiety effect of educational kinesiology in kindergarteners with special needs by elevating the oxytocin levels. Future studies are warranted to further confirm our findings with a larger sample.

The Impact of a 12-Month Activity Tracker Intervention on Activity Behavior Across Body Mass Index Subgroups Among Recent Retirees: Post Hoc Analysis of a Randomized Controlled Trial.

This study examined the effectiveness of a 12-month activity tracker-based intervention on activity behavior among recent retirees (Enhancing physical ACTivity and healthy aging among recent REtirees [REACT]) in subgroups based on body mass index. REACT trial randomized 231 participants (mean age 65.2) into intervention and control groups. Main outcomes were accelerometer-measured moderate-to-vigorous (MVPA) and light physical activity (LPA) and sedentary time (SED) measured at baseline and 3-, 6-, and 12-month follow-ups. As a post hoc analysis, the intervention effect was examined among participants with normal weight (n = 77), overweight (n = 89), and obesity (n = 61). An intervention effect was observed among participants with obesity in LPA (time × group P = .045) mirrored by a similar, albeit nonsignificant, effect in SED (P = .067), but not in MVPA (P = .92). A transient increase of 41 minutes per day (95% confidence interval, 14 to 68) in LPA was observed at 6 months among the intervention group, with a concomitant decrease of 42minutes per day (-72 to -12) in SED. However, these changes were not maintained at 12months. No between-group differences in changes over time were observed among participants with normal or overweight. Activity trackers may be particularly suitable for promoting changes in LPA and SED among older adults with obesity. However, their long-term effectiveness might be limited.

Flat flexible compared to stable supportive footwear for self-managing knee osteoarthritis symptoms: a randomised clinical trial

Introduction: International clinical guidelines advise stable supportive shoes for knee osteoarthritis (OA) however evidence suggests flat flexible shoes may reduce knee joint loading and symptoms. We hypothesised that flat flexible shoes would lead to greater improvements in pain and function, compared to stable supportive shoes. Methods: This was a two-arm, participant- and assessor-blinded comparative effectiveness randomised controlled trial. We recruited 164 people aged 50 years or older with knee pain on most days of the past month and moderate to severe radiographic medial tibiofemoral OA. Participants were randomised to receive either flat flexible shoes (n=82) or stable supportive shoes (n=82), classified based on: i) differences in shoe heel height/thickness, ii) shoe pitch, iii) arch support/motion control features, iv) sole flexibility and v) weight. Shoes were worn >6 hours/day for 6 months. Primary outcomes were changes in walking knee pain (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index subscale, 0-68) at 6-months. Secondary outcomes included additional measures of pain, function, physical activity, quality of life and adverse events. Results: 164 participants were recruited and 161 (98%) completed 6-month primary outcomes. There was evidence of a between-group difference in change in walking knee pain favoring stable supportive shoes (mean difference=1.1 units (95%CI 0.5 to 1.8; p=0.001) but no strong evidence of difference in function (2.3 (-0.9 to 5.5; p=0.17)). Furthermore, 46 (58%) participants in the stable supportive group achieved the minimal clinically important difference (MCID) in pain, compared to 32 (40%) in the flat flexible group (relative risk 1.56, 1.05 to 2.02). Improvements in knee-related quality of life and ipsilateral hip pain also favored stable supportive shoes (-5.3 (-10.0 to -0.5; p=0.03) and 0.7 (0.0 to 1.4; p=0.04), respectively), with no evidence of between-group differences in other secondary outcomes. Fewer participants reported adverse events with stable supportive shoes (n=12 (15%)) compared to flat flexible shoes (n=26 (32%); relative risk=0.46 (0.25 to 0.84; p=0.012)). Discussion: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes. Furthermore, a greater proportion of participants allocated to stable supportive shoes achieved the MCID in walking pain compared to those allocated to flat flexible shoes. Findings from this trial are the first to show that stable supportive shoes may be an inexpensive, low burden self-management strategy to improve pain associated with knee OA. Conflict of interest statement: My co-authors and I acknowledge that we have no conflict of interest of relevance to the submission of this abstract

Effect of ideal protein versus low-fat diet for weight loss: A randomized controlled trial.

BackgroundCurrent guidelines call for peer‐reviewed evidence of efficacy and safety for commercial weight loss programs to be recommended as options for those seeking to lose weight.ObjectivesThis study investigated the Ideal Protein (IP) system, a commercial weight loss program, compared to a guideline‐based, low‐calorie/low‐fat (LCLF) dietary behavioral intervention on body weight and CVD risk factors in adults with obesity.MethodsIn this randomized, assessor‐blinded, parallel‐group trial, 192 participants with body mass index (BMI) ≥30 and ≤49 kg/m2 were assigned to either the IP Phase I diet or LFLC diet interventions. The IP Phase I is focused on lean protein and vegetables with avoidance of fruit and dairy, while the LFLC diet goals include <30% of daily energy from fat, <7% from saturated fat, 55% from carbohydrate, and an energy deficit of 500 kcal/day. The primary endpoint was change in body weight at 3 months. Secondary endpoints included change in waist circumference (WC), hip circumference (HC), total cholesterol (TC), low‐density lipoprotein cholesterol (LDL‐C) and high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG), fasting glucose (FG), systolic blood pressure (SBP) and diastolic blood pressure (DBP).ResultsThe mean ± SD of change in weight at 3 months was −9.6 ± 12.7 kg in the IP group as compared to −1.6 ± 27.2 kg in the LFLC group. The mean between‐group difference in change at 3 months was −8.1 kg (95% confidence interval [CI] −16.6 to 0.6; p = 0.05). Additional significant between‐group differences included WC, HC, TC, and TG levels, all favoring the IP group. There were no serious adverse events during the intervention period.ConclusionsThe present findings demonstrate the efficacy and safety of the IP weight loss program as compared to a guideline‐based LCLF dietary behavioral intervention among black and white adults with obesity and CVD risk factors, providing support for the effectiveness of the program.

Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials

BackgroundThe aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.MethodsWe used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians’ input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated.ResultsTwo clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and − 13 to − 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and − 10 to − 5 for deterioration.ConclusionsOur findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

Collective motion diminishes, but variation between groups emerges, through time in fish shoals.

Despite extensive interest in the dynamic interactions between individuals that drive collective motion in animal groups, the dynamics of collective motion over longer time frames are understudied. Using three-spined sticklebacks, Gasterosteus aculeatus, randomly assigned to 12 shoals of eight fish, we tested how six key traits of collective motion changed over shorter (within trials) and longer (between days) timescales under controlled laboratory conditions. Over both timescales, groups became less social with reduced cohesion, polarization, group speed and information transfer. There was consistent inter-group variation (i.e. collective personality variation) for all collective motion parameters, but groups also differed in how their collective motion changed over days in their cohesion, polarization, group speed and information transfer. This magnified differences between groups, suggesting that over time the ‘typical’ collective motion cannot be easily characterized. Future studies are needed to understand whether such between-group differences in changes over time are adaptive and represent improvements in group performance or are suboptimal but represent a compromise between individuals in their preferences for the characteristics of collective behaviour.

Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial

Introduction Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST) improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Here, we compared effects of RPSS vs sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke. Methods This single-center, randomized, placebo-controlled, parallel-group clinical trial compared effects of 18 sessions of either 1.5 h of active RPSS or sham followed by a supervised session that included 45 min of TST of the paretic upper limb. In both groups, subjects were instructed to perform functional tasks at home, without supervision. The primary outcome measure was the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. Grasp and pinch strength were secondary outcomes. Results In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment. Grasp strength improved significantly in the active, but not in the sham group, at 3 and 6 weeks. Pinch strength improved significantly in both groups at 3 weeks, and only in the active group at 6 weeks. Conclusions The between-group difference in changes in WMFT was not statistically significant. Despite the short duration of supervised treatment, WMFT improved significantly in subjects treated with RPSS or sham. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients. In addition, RPSS led to significant gains in hand strength. Trial Registry Name: Peripheral Nerve Stimulation and Motor Training in Stroke Clinical Trials.gov identifier: NCT0265878 https://clinicaltrials.gov/ct2/show/NCT02658578

A Tenodesis-Induced-Grip exoskeleton robot (TIGER) for assisting upper extremity functions in stroke patients: a randomized control study

Purpose This study was aimed toward developing a lightweight assisting tenodesis-induced-grip exoskeleton robot (TIGER) and to examine the performance of the TIGER in stroke patients with hemiplegia. Methods This was a single-blinded, randomized control trial with pre-treatment, immediate post-treatment, and 12-week follow-up assessments. Thirty-four stroke patients were recruited and randomized to either an experimental or control group, where each participant in both groups underwent 40 min of training. In addition to a 20-min bout of regular task-specific motor training, each participant in the experimental group received 20 min of TIGER training, and the controls received 20 min of traditional occupational therapy in each treatment session. Primary outcomes based on the Fugl-Meyer Motor Assessment of Upper Extremity (FMA-UE) were recorded. Results Thirty-two patients (94.1%) completed the study: 17 and 15 patients in the experimental and control groups, respectively. Significant beneficial effects were found on the total score (ANCOVA, p = 0.006), the wrist score (ANCOVA, p = 0.037), and the hand score (ANCOVA, p = 0.006) for the FMA-UE in the immediate post-treatment assessment of the participants receiving the TIGER training. Conclusion The TIGER has beneficial effects on remediating upper limb impairments in chronic stroke patients. Clinical trial registration: ClinicalTrials.gov; identifier NCT03713476 Implications for rehabilitation Based on use-dependent plasticity concepts, robot training with the more distal segments of the upper extremities has a beneficial effect in patients with chronic stroke. A novel lightweight assisting tenodesis-induced-grip exoskeleton robot (TIGER) system using a mechanism involving musculotendinous coordination of the wrist and hand was proposed in this study. Between-group differences in changes in the upper limb motor performance were observed in the experimental group as compared to patients in the control group. For patients with chronic stroke, receiving 20 min of TIGER training in conjunction with 20 min of task-specific motor training led to clinically important changes in motor control and functioning of the affected upper limb.

Benefits and Risks of Iron Interventions in Infants in Rural Bangladesh

BackgroundUniversal provision of iron supplements (drops or syrup) or multiple micronutrient powders to young children in low-to-middle-income countries where anemia is prevalent is recommended by the World Health Organization and widely implemented. The functional benefits and safety of these interventions are unclear.MethodsWe conducted a three-group, double-blind, double-dummy, individually randomized, placebo-controlled trial to assess the immediate and medium-term benefits and risks of 3 months of daily supplementation with iron syrup or iron-containing multiple micronutrient powders, as compared with placebo, in 8-month-old children in rural Bangladesh. The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores indicating better cognitive performance. Secondary outcomes included the cognitive composite score at 9 months after completion of the assigned regimen; behavioral, language, and motor development, as well as growth and hematologic markers, immediately after completion and at 9 months after completion; and safety.ResultsWe randomly assigned 3300 infants to receive iron syrup (1101 infants), multiple micronutrient powders (1099), or placebo (1100) daily. After completion of the assigned 3-month regimen, no apparent effect on the cognitive composite score was observed with iron syrup as compared with placebo (mean between-group difference in change in score from baseline, −0.30 points; 95% confidence interval [CI], −1.08 to 0.48) or with multiple micronutrient powders as compared with placebo (mean between-group difference in change in score from baseline, 0.23 points; 95% CI, −0.55 to 1.00). No apparent effect on any other developmental or growth outcome was observed immediately after completion of the assigned regimen or at 9 months after completion. At 9 months after completion of the assigned regimen, the prevalences of anemia, iron deficiency, and iron deficiency anemia increased in all three trial groups but remained lower among the children who received iron syrup or multiple micronutrient powders than among those who received placebo. The risk of serious adverse events and incidence of symptoms of infection were similar in the three trial groups.ConclusionsIn this trial involving infants in Bangladesh, 3 months of daily supplementation with iron syrup or multiple micronutrient powders did not appear to have an effect on child development or other functional outcomes as compared with placebo. (Funded by the National Health and Medical Research Council of Australia; BRISC Australian New Zealand Clinical Trials Registry number, ACTRN12617000660381.)

Effect of a Musical Intervention During the Implantation of a Central Venous Catheter or a Dialysis Catheter in the Intensive Care Unit: A Prospective Randomized Pilot Study.

Listening to music may reduce anxiety during medical procedures. However, the magnitude of any effect may differ with respect to patient and procedure. We evaluated the effect of a musical intervention on patient anxiety during a central venous catheter or dialysis catheter implantation in an intensive care unit. A prospective single-center controlled open-label 2-arm randomized trial was conducted in a medical intensive care unit (ICU) from February 2018 to February 2019. Patients undergoing central venous catheterization were randomized to listening to music or not during the procedure. Patients randomized to music listened to the Music Care application via headphones. The primary outcome was the change in anxiety assessed on a 100-mm Visual Analogue Scale between the beginning and end of the catheterization procedure. Secondary outcomes included postprocedural pain. We included 37 patients in the musical intervention group and 35 in the standard care group. The primary reasons for intensive care unit admission were the need for a central catheter for chemotherapy for hematologic malignancy and sepsis and/or septic shock in both groups. Postprocedural anxiety and pain assessments were missing in 1 (2.7%) and 4 (11.4%) patients in the intervention and standard care groups. We found no between-group difference in change in anxiety score: median -1 (interquartile range, -3 to 0) vs 0 (-3 to 0) in the musical intervention and standard care groups (median difference, -1 [-2 to 0]) (P = .24). Postprocedural pain score did not differ between the groups: median 0 (0-2) and 0 (0-3.75) in the musical intervention and standard care groups (median difference, -0 [0-0]) (P = .40). To account for missing outcome assessments, sensitivity analyses were performed using 2 extreme scenarios, one favoring the standard care group (scenario 1) and the other favoring the intervention group (scenario 2). In either scenario, change in anxiety score did not differ between the intervention and standard care groups: -1 (-3 to 0) vs 0 (-4 to 0) (P = .88) in scenario 1 and -1 (-3 to 0) vs 0 (-2.75 to 1) (P = .07) in scenario 2. In this first randomized pilot study of musical intervention for central venous catheterization in awake patients in the intensive care unit, the musical intervention did not reduce patients' anxiety as compared with usual care.

Neuromuscular Electric Stimulation in Addition to Exercise Therapy in Patients with Lower Extremity Paresis Due to Acute Ischemic Stroke. A proof-of-concept randomised controlled trial

IntroductionExercise therapy and neuromuscular electrical stimulation (NMES) during the initial 14 days after stroke may benefit recovery of gait. We aimed to determine whether poststroke NMES of vastus medial and tibial muscles during exercise therapy is more effective than exercise therapy alone. Materials and methodsIn this proof-of-concept randomised trial patients with first-ever acute ischemic stroke and a leg paresis (40–85 years of age) were randomised (1:1) to 10 min of daily NMES + exercise therapy or exercise therapy alone. Primary outcome was the between-group difference in change in 6 min Walk Test (6MWT) at 90 days post stroke estimated with a mixed regression model. Secondary outcomes included 10 m Walk Test, Fugl-Meyer Motor Assessment, Guralnik Timed Standing Balance, Sit to Stand, Timed Up and Go, EQ-5D-5L, Montreal Cognitive Assessment and Becks Depression Inventory. Results50 stroke survivors (25 in each group) with a mean age of 67 years (range 43–83) were included. An insignificant between-group difference in change of 28.3 m (95%CI -16.0 to 72.6, p = 0.23, adjusted for baseline) in 6MWT at 90-days follow-up was found, in favour of the NMES group. All secondary outcomes showed no statistically significant between-group difference. The conclusion was that adding NMES to exercise therapy had no effect on poststroke walking distance measured by the 6 MWT or any of the secondary outcomes. ConclusionsIn this proof-of-concept RCT, we demonstrated that NMES in addition to exercise therapy during the first 14 days after onset of ischemic stroke did not improve walking distance or any of the secondary outcomes. Future studies with a longer trial period, stratifying patients into subgroups with comparable patterns of expected spontaneous recovery – if possible within 48 h post stroke, and greater sample size, than in this study are suggestions of how rehabilitation research could go on exploring the potential for NMES as an amplifier in stroke recovery.

Contralesional Cathodal Transcranial Direct Current Stimulation Does Not Enhance Upper Limb Function in Subacute Stroke: A Pilot Randomized Clinical Trial.

Transcranial direct current stimulation (tDCS) has the potential to improve upper limb motor outcomes after stroke. According to the assumption of interhemispheric inhibition, excessive inhibition from the motor cortex of the unaffected hemisphere to the motor cortex of the affected hemisphere may worsen upper limb motor recovery after stroke. We evaluated the effects of active cathodal tDCS of the primary motor cortex of the unaffected hemisphere (ctDCSM1UH) compared to sham, in subjects within 72 hours to 6 weeks post ischemic stroke. Cathodal tDCS was intended to inhibit the motor cortex of the unaffected hemisphere and hence decrease the inhibition from the unaffected to the affected hemisphere and enhance motor recovery. We hypothesized that motor recovery would be greater in the active than in the sham group. In addition, greater motor recovery in the active group might be associated with bigger improvements in measures in activity and participation in the active than in the sham group. We also explored, for the first time, changes in cognition and sleep after ctDCSM1UH. Thirty subjects were randomized to six sessions of either active or sham ctDCSM1UH as add-on interventions to rehabilitation. The NIH Stroke Scale (NIHSS), Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA), Barthel Index (BI), Stroke Impact Scale (SIS), and Montreal Cognitive Assessment (MoCA) were assessed before, after treatment, and three months later. In the intent-to-treat (ITT) analysis, there were significant GROUP∗TIME interactions reflecting stronger gains in the sham group for scores in NIHSS, FMA, BI, MoCA, and four SIS domains. At three months post intervention, the sham group improved significantly compared to posttreatment in FMA, NIHSS, BI, and three SIS domains while no significant changes occurred in the active group. Also at three months, NIHSS improved significantly in the sham group and worsened significantly in the active group. FMA scores at baseline were higher in the active than in the sham group. After adjustment of analysis according to baseline scores, the between-group differences in FMA changes were no longer statistically significant. Finally, none of the between-group differences in changes in outcomes after treatment were considered clinically relevant. In conclusion, active CtDCSM1UH did not have beneficial effects, compared to sham. These results were consistent with other studies that applied comparable tDCS intensities/current densities or treated subjects with severe upper limb motor impairments during the first weeks post stroke. Dose-finding studies early after stroke are necessary before planning larger clinical trials.

Pilot randomized clinical trial targeting anxiety sensitivity: effects on physical activity

ABSTRACT Anxiety sensitivity (AS)—the tendency to interpret anxiety as an aversive state—is associated with low rates of physical activity. Previous interventions targeting AS via exercise-based interoceptive exposure have not assessed physical activity as an outcome and are limited by brief follow-up periods. This study replicated and extended previous work by including a 6-week follow-up and assessing physical activity. Participants were 44 sedentary young adults with elevated AS randomized to intervention (six 20-minute sessions of moderate-intensity walking) or assessment-only control. Assessments of AS and physical activity were conducted at baseline and weeks 2 (post-treatment), 4, and 8. Between-group change in AS and physical activity over time was assessed using hierarchical linear modeling. The intervention condition demonstrated a marginally significant reduction in AS compared to control at week 4, which eroded by week 8. There were no significant between-group differences for change in physical activity. Findings indicate that a brief intervention might not be sufficient to produce lasting changes in AS or related exercise avoidance without additional treatment. Intervention effects were weaker than previous reports, which may be due to the greater racial/ethnic diversity of the current sample. Future research should objectively measure physical activity and explore individual variability in response.ClinicalTrials.gov identifier: NCT03128437

The effect of intermittent energy restriction on weight loss and diabetes risk markers in women with a history of gestational diabetes: a 12-month randomized control trial

Weight loss after gestational diabetes (GDM) can prevent or delay the onset of type 2 diabetes. Intermittent energy restriction (IER) may offer an alternative to continuous energy restriction (CER) for weight loss. We compared the effects of IER (2 days per week) to daily CER over 12 mo on weight loss and diabetes risk markers in overweight women with previous GDM. Overweight females (n=121) ≥18 y were randomized 1:1 to either IER [2-d 500 kcal (2100 kJ); n=61] or CER [1500 kcal (6000 kJ); n=60] in this 12-mo noninferiority trial. The trial was completed by 62 participants with a median age of 39.6 y [Quartile (Q) 1 to Quartile 3, 34.9 to 43.9 y] with a median BMI of 32.6 kg/m2 (Q1 to Q3, 28.5 to 37.9 kg/m2) at a median of 2.9 y after GDM (Q1 to Q3, 2.1 to 6.4 y; 49% attrition; IER n=29; CER n=30; P=0.8). The mean±SD weight loss was significant over time (P<0.001) but not by diet group (IER -4.8±5.0 kg; CER -3.2±5.0; P=0.2). The mean between-group difference was -1.6 kg (95% CI: -4.2 to 1.0 kg; P=0.2). There were no significant between-group differences in change in HbA1c, fasting plasma glucose, fasting serum insulin, HOMA-IR or 2-h oral glucose tolerance at 12 mo (p>0.05). The trial was registered at https://www.anzctr.org.au/ (ACTRN12617001476325). IER produces comparable weight loss to CER over 12 mo in overweight women with previous GDM. The high dropout rate in this study is a limitation in the interpretation of these results. Larger studies are needed to confirm noninferiority of IER compared to CER.

A telerehabilitation programme in post-discharge COVID-19 patients (TERECO): a randomised controlled trial

ObjectivesTo investigate superiority of a telerehabilitation programme for COVID-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL)...