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Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

ABSTRACT: OBJECTIVES:For people with end-stage renal disease requiring haemodialysis, exercise can improve aspects of quality of life (QoL). However, the relative benefits and risks of different types of exercise in this population are unknown. Therefore, this pilot study aimed to evaluate the feasibility of a main study evaluating the efficacy of cycling and resistance exercise each performed during the haemodialysis treatment on QoL. METHODS:In this factorial (2×2) pilot trial, 31 haemodialysis patients were randomised to cycling, resistance, cycling and resistance, or an attention control. Feasibility was defined a priori by criteria on recruitment, fidelity to the protocol and patient response to the intervention. To better understand feasibility, we conducted interviews with dialysis unit staff and trial participants. As secondary outcomes, we estimated the main effect of cycling and weights each compared with control on QoL, physical function and strength. FINDINGS:We exceeded the target accrual of 28 participants over 12?weeks. Irrespective of exercise group allocation, adherence was high; of the 1038 training sessions offered, 87% were initiated and over 80% of exercise sessions were performed as per protocol. Progression based on perceived exertion, individual instruction and interactions with the kinesiologist facilitated acceptability across exercise groups. Using an attention control, measures of contamination and attrition were low. Important barriers to unit staff readiness for the intervention were initial safety and workflow concerns, unit workload and onerous data collection. Secondary outcomes were not statistically significant. Adverse events were low and did not increase with a higher volume of exercise. CONCLUSIONS:The main study is feasible with minor modifications. In addition to practical assistance, involvement from unit staff could increase patient participation and improve trial implementation. Strategies to increase acceptability of the intervention for staff include improving workflow integration and using a prestudy demonstration phase to introduce the intervention. TRIAL REGISTRATION NUMBER:NCT02234232.

SUBMITTER: Thompson S

PROVIDER: S-EPMC5020875 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

Thompson Stephanie S Klarenbach Scott S Molzahn Anita A Lloyd Anita A Gabrys Iwona I Haykowsky Mark M Tonelli Marcello M

BMJ open 20160906 9

<h4>Objectives</h4>For people with end-stage renal disease requiring haemodialysis, exercise can improve aspects of quality of life (QoL). However, the relative benefits and risks of different types of exercise in this population are unknown. Therefore, this pilot study aimed to evaluate the feasibility of a main study evaluating the efficacy of cycling and resistance exercise each performed during the haemodialysis treatment on QoL.<h4>Methods</h4>In this factorial (2×2) pilot trial, 31 haemodi ...[more]

PMID: 27601500

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Project description:ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

Project description:Interventions: This study was a 16-week exercise intervention programme done prior to surgery with assessments undertaken at three time-points: (1) baseline, (2) immediately pre-surgery and (3) 8-week post-surgery follow-up. This is a 16 weeks exercise programme that commenced prior to the schedule surgery. Patients undertook an exercise programme that consisted of two supervised clinic sessions per week. Each supervised exercise session took approximately 60 minutes to complete. Sessions commenced with a 5-minute warm-up consisting of moderate level of aerobic exercise (~60% heart rate maximum (HRmax)), as well as stretching exercises of the major muscle groups: chest, shoulder, biceps, triceps, quadriceps, hamstrings and calf muscles. This was followed by a resistance-training regime that included a series of six exercises targeting the major muscles of the upper- and lower-body. Upper-limb exercises included chest press, seated row and lat pull-down. Lower-limb exercises were leg extension, leg curl and leg press. All exercises were performed through the full range of motion adhering to correct techniques. To ensure the progressive nature of the training programme, patients were encouraged to work past the repetition maximum (RM) prescribed, with resistance increased by 5 – 10% for the subsequent set/training sessions if they were able to exceed the number specified. Progression of resistance followed guidelines previously outlined by Galvao and Newton (2005). The training phases were as follows: week 1 – 2 (two sets 12 RM), week 3 – 5 (three sets of 10 RM), week 6 – 8 (three sets of 8 RM), and week 9 – 10 (four sets of 6 RM). After week 10, the training phases set in week 1 – 2 were resumed to implement a periodised exercise model. A further 20 minutes of aerobic exercise was unde Primary outcome(s): The primary objective of this feasibility study was to determine the efficacy of a supervised, pre-surgical exercise programme consisting of targeted resistance and aerobic training for rectal cancer patients scheduled to received rectal resection surgery. Specifically, we aimed to investigate the effects of a pre-surgical exercise intervention on neuromuscular strength using the one-repetition maximum chest press, leg press, seated row and leg extension exercise protocol[Baseline, pre-surgery and 8-weeks post-surgery] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

Project description:Background/Objectives: Aerobic exercise and mind-body exercise, are vital for improving motor and non-motor functional performance of Parkinson's disease (PD). However, evidence-based recommendations on which type of exercise is most suitable for each individual are still lacking. Therefore, we conduct a network meta-analysis to assess the relative efficacy of aerobic and mind-body exercise on motor function and non-motor symptoms in Parkinson's disease and to determine which of these therapies are the most suitable. Design: A network meta-analysis and dose-response analysis. Setting and Participants: Medline, Embase (all via Ovid), and the Cochrane Central Register of Controlled Trials were comprehensively searched for related trials through April 2021. Measurements: Study quality was evaluated using the Cochrane Risk of Bias Tool. The effect sizes of continuous outcomes were calculated using mean differences (MDs) or standardized mean differences (SMDs). A network meta-analysis with a frequentist approach was conducted to estimate the efficacy and probability rankings of the therapies. The dose-response relationship was determined based on metaregression and SUCRA. Results: Fifty-two trials with 1971 patients evaluating six different therapies were identified. For the UPDRS-motor score and TUG score, yoga all ranked highest (SUCRA = 92.8%, 92.6%, respectively). The SUCRA indicated that walking may best improve the BBS score (SUCRA = 90.2%). Depression, cognitive and activities of daily living scores were significantly improved by yoga (SUCRA: 86.3, 95.1, and 79.5%, respectively). In the dose-response analysis, 60-min sessions, two times a week might be the most suitable dose of yoga for reducing the UPDRS-motor score of PD patients. Conclusion: Yoga and walking are important options for increasing functional mobility and balance function, and yoga might be particularly effective for decreasing depressive symptoms and cognitive impairment and improving activities of daily living in PD. The potential optimal dose of yoga for enhancing motor ability in PD patients is 60-min sessions, two times a week. Registration: PROSPERO CRD42021224823.

Project description:BackgroundFrailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD.MethodsParticipants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability.ResultsSix hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence.ConclusionsThis pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD.Trial registrationISRCTN87708989; https://clinicaltrials.gov/.

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Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

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Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

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