Dataset Information

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study.

ABSTRACT:

Introduction

Physical activity (PA) protects the cardiovascular system and reduces the risk of stroke recurrence. However, most stroke survivors have significantly lower daily PA levels than those recommended. Adapted PA programmes provide a useful means of increasing the daily PA levels of this population. PA programmes designed to encourage people walking have been found to be more effective than no intervention. Some programmes have been applied in institutional settings while others are done on an independent basis. The aim of this study will be to compare the two methods in terms of their impact on the daily walking rates of subjects with spastic hemiparesis following a chronic stroke. Secondary outcomes will include effects on walking ability, endurance, balance, quality of life and motivation for exercise.

Methods and analysis

This French single-centre randomised (1:1), controlled, two-arm, parallel, single-blind study will include 40 adults with chronic stroke spastic hemiparesis who are able to walk for 6 min. The primary outcome will be the participants' daily activity measured via the number of steps performed per day using a Stepwatch device. We expect to establish that the institution-based programme will be more effective than a self-managed programme as a means of increasing the PA of chronic stroke subjects.

Ethics and dissemination

The protocol was approved by an independent National Ethics Committee (Comité de Protection des personnes Est IV). Participants will be asked to provide their signed informed consent prior to the study. The results will be disseminated via publications in the scientific literature, oral and poster presentations by partners at international scientific meetings and associations of patients.

Trial registration

NCT06061770.

SUBMITTER: Satger E

PROVIDER: S-EPMC11261681 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study.

Satger Etienne E Prieur-Blanc Nicolas N Viton Jean-Michel JM Auquier Pascal P Bensoussan Laurent L Cotinat Maëva M

BMJ open 20240720 7

<h4>Introduction</h4>Physical activity (PA) protects the cardiovascular system and reduces the risk of stroke recurrence. However, most stroke survivors have significantly lower daily PA levels than those recommended. Adapted PA programmes provide a useful means of increasing the daily PA levels of this population. PA programmes designed to encourage people walking have been found to be more effective than no intervention. Some programmes have been applied in institutional settings while others ...[more]

PMID: 39032927

Similar Datasets

Project description:IntroductionAmyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease with variable and complex clinical manifestations that requires a multidisciplinary approach. However, face-to-face treatment in this population may experience barriers, such as difficulty accessing physical therapists or other professionals. As a result, strategies (eg, telerehabilitation) emerged to facilitate treatment and physical therapy monitoring. This study aims to evaluate the effects of remote versus face-to-face home-based exercise programmes on clinical outcomes and treatment adherence of people with ALS.Methods and analysisThis is a single-blind randomised clinical trial protocol that will include 44 people with clinical diagnosis of ALS at any clinical stage and aged between 18 and 80 years. Participants will be randomised into two groups after face-to-face evaluation and perform a home-based exercise programme three times a week for 6 months. A physical therapist will monitor the exercise programme once a week remotely (phone calls-experimental group) or face-to-face (home visits-control group). The primary outcome measure will be functional capacity (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised). Secondary outcomes will include disease severity (Amyotrophic Lateral Sclerosis Severity Scale), fatigue (Fatigue Severity Scale), pain (Visual Analogue Scale and body pain diagram), adverse events and adherence rate. Outcomes will be initially evaluated face-to-face and revaluated remotely every 2 months and 1 month after interventions. Linear mixed models will compare outcome measures between groups and evaluations (α=5%).Ethics and disseminationThis study was approved by the research ethics committee of Hospital Universitário Onofre Lopes/Universidade Federal do Rio Grande do Norte (no. 3735479). We expect to identify the effects of an exercise programme developed according to ALS stages and associated with remote or face-to-face monitoring on clinical outcomes using revaluations and follow-up after interventions.Trial registration numberBrazilian Registry Clinical Trials (RBR-10z9pgfv).

Project description:BackgroundMany Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group.Methods/designThis is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax) aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised.DiscussionThe efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study will provide information, which at present is lacking, on safety of aerobic exercise in Polio, as potential negative outcomes of activity including loss of muscle strength, increased pain and fatigue will be closely monitored.

Project description:BackgroundCardiometabolic diseases are a major cause of morbidity and mortality in kidney transplant recipients (KTR) due to clustering of traditional and non-traditional risk factors including poor physical fitness and physical inactivity. Exercise may mitigate the risk of these diseases in this population but evidence is limited, and physical activity levels are low. The ECSERT randomised controlled trial assessed the feasibility of delivering a structured, home-based exercise intervention in KTR at increased cardiometabolic risk.MethodsFifty KTR (>1-year post-transplant) were randomised 1:1 to: intervention (INT: a 12-week home-based combined aerobic and resistance exercise programme) or control (CTR: guideline-directed care). The a-priori thresholds for feasibility were: recruitment of 20% of eligible participants (≥2 participants per month); adherence (an average of ≥ 3 exercise sessions per week); and attrition (≤30%).ResultsOne hundred and seventy-one patients were screened and 94 (55%) were eligible and invited to take part in the study. Fifty of those invited (53%) were recruited across 22 months of recruitment. Consented participant characteristics were: age 50 ± 14 years (INT 49 ± 13; CTR 51 ± 15), 23 male (INT 10; CTR 13), eGFR 59 ± 19 ml/min/1.73m2 (INT 60 ± 20; CTR 61 ± 21), 35 White British (WB), 13 South Asian (SA), 1 Caribbean, and 1 Mixed ethnicity (INT 17 WB, 7 SA, 1 Mixed; CTR 18 WB, 6 SA, 1 Caribbean). Intervention participants (n = 22 completed) recorded an average of 4.4 ± 1.4 exercise sessions per week (aerobic 2.8 ± 1.1; strength 1.6 ± 0.5). Three participants withdrew from the intervention group (1 COVID-19 infection, 1 recurrent urine infections unrelated to the trial, 1 time/family circumstances) and one from the control group (lost to follow-up; 8% attrition). There were no serious adverse events reported.ConclusionDespite previous evidence showing physical fitness and activity levels are low in KTR, the present results support that a structured, home-based exercise programme is feasible in this population. Specifically, a-priory recruitment, adherence, and retention thresholds were all exceeded. The groups were well matched and there was encouraging representation of female participants and participants from a non-white background. Thus, this study supports further development and testing of home-based programmes of exercise and activity for KTR.Trial registrationClinicalTrials.gov NCT04123951.

Project description:BackgroundBreast cancer is the most common female malignancy worldwide and a major cause of morbidity and mortality. Exercise during adjuvant treatment improves function and relieves symptoms in breast cancer survivors. However, it is unclear if an unsupervised exercise programme may be as effective as a supervised multimodal group. We investigated the feasibility and efficacy of a centre-based multidimensional rehabilitation (MDR) programme for breast cancer survivors undergoing adjuvant treatment and compared it to an unsupervised home-based exercise (HE) programme.MethodsParticipants were self-allocated to either MDR or HE group. MDR participants underwent 24 supervised exercise classes and 10 education classes over 12 weeks. HE participants were instructed on a home exercise regime. Outcome measures, including the 6-min walk test (6MWT) and Frenchay Activities Index (FAI), FACT-Cognitive Function scale, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, were conducted at baseline (W0), post-intervention (W12) and 6-months post-intervention (M6). Variance between time points and the 2 groups were analysed using a linear mixed model (unstructured covariance matrix) and adjusted with Bonferroni.ResultTwenty-five participants attended at least half of the MDR interventions, while 21 completed the HE interventions. The former showed significant improvement in 6MWT, from 406.88 m (W0) to 443.34 m (W12) to 452.81 m (M6), while the improvement in the HE group was not significant (407.67 m (W0) to 433.14 m (W12) to 430.96 m (M6)). Both groups showed a significant improvement in FAI, with earlier significant improvement noted at W12 in the MDR group (22.71 (W0) to 27.65 (W12) to 28.81 (M6)) compared to the HE group (23.16 (W0) to 26.47 (W12) to 29.85 (M6)). Dropout rate was 16% in the MDR group and 34% in HE group. Overall satisfaction with the MDR programme was high.ConclusionBoth MDR and HE programmes were feasible. MDR was superior in improving endurance and earlier return to instrumental activities for those who completed at least half of the sessions. Future studies could explore use of technology to improve adherence to exercise.Trial registrationThe study was registered with ClinicalTrial.gov on 01/04/2022 with the registration number NCT05306808.

Project description:INTRODUCTION:Living donor kidney transplantation (LDKT) is the optimal treatment for most patients with end-stage renal disease (ESRD). However, there are numerous patients who cannot find a living kidney donor. Randomised controlled trials have shown that home-based education for patients with ESRD and their family/friends leads to four times more LDKTs. This educational intervention is currently being implemented in eight hospitals in the Netherlands. Supervision and quality assessment are being employed to maintain the quality of the intervention. In this study, we aim to: (1) conduct a cost-effectiveness analysis of the educational programme and its quality assurance system; (2) investigate the relationship between the quality of the implementation of the intervention and the outcomes knowledge, communication and LDKT activities; and (3) investigate policy implications. METHODS AND DESIGN:Patients with ESRD who do not have a living kidney donor are eligible to receive the home-based educational intervention. This is carried out by allied health transplantation professionals and psychologists across eight hospitals in the Netherlands. The cost-effectiveness analysis will be conducted with a Markov model. Cost data will be obtained from the literature. We will obtain the quality of life data from the patients who participate in the educational programme. Questionnaires on knowledge and communication will be used to measure the outcomes of the programme. Data on LDKT activities will be obtained from medical records up to 24 months after the education. A protocol adherence measure will be assessed by a third party by means of a telephone interview with the patients and the invitees. ETHICS AND DISSEMINATION:Ethical approval was obtained through all participating hospitals. Results will be disseminated through peer-reviewed publications and scientific presentations. Results of the cost-effectiveness of the educational programme will also be disseminated to the Dutch National Health Care Institute. TRIAL REGISTRATION NUMBER:NL6529.

Dataset Information

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Publications

Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets