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Anabolic exercise in haemodialysis patients: a randomised controlled pilot study.

ABSTRACT: The anabolic response to progressive resistance exercise training (PRET) in haemodialysis patients is unclear. This pilot efficacy study aimed to determine whether high-intensity intradialytic PRET could reverse atrophy and consequently improve strength and physical function in haemodialysis patients. A second aim was to compare any anabolic response to that of healthy participants completing the same program.In a single blind controlled study, 23 haemodialysis patients and 9 healthy individuals were randomly allocated to PRET or an attention control (SHAM) group. PRET completed high-intensity exercise leg extensions using novel equipment. SHAM completed low-intensity lower body stretching activities using ultra light resistance bands. Exercises were completed thrice weekly for 12 weeks, during dialysis in the haemodialysis patients. Outcomes included knee extensor muscle volume by magnetic resonance imaging, knee extensor strength by isometric dynamometer and lower body tests of physical function. Data were analysed by a per protocol method using between-group comparisons.PRET elicited a statistically and clinically significant anabolic response in haemodialysis patients (PRET-SHAM, mean difference [95 % CI]: 193[63 to 324]?cm(3)) that was very similar to the response in healthy participants (PRET-SHAM, 169[-41 to 379]?cm(3)). PRET increased strength in both haemodialysis patients and healthy participants. In contrast, PRET only enhanced lower body functional capacity in the healthy participants.Intradialytic PRET elicited a normal anabolic and strength response in haemodialysis patients. The lack of a change in functional capacity was surprising and warrants further investigation.

SUBMITTER: Kirkman DL

PROVIDER: S-EPMC4159488 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Anabolic exercise in haemodialysis patients: a randomised controlled pilot study.

Kirkman Danielle L DL Mullins Paul P Junglee Naushad A NA Kumwenda Mick M Jibani Mahdi M MM Macdonald Jamie H JH

Journal of cachexia, sarcopenia and muscle 20140408 3

<h4>Background</h4>The anabolic response to progressive resistance exercise training (PRET) in haemodialysis patients is unclear. This pilot efficacy study aimed to determine whether high-intensity intradialytic PRET could reverse atrophy and consequently improve strength and physical function in haemodialysis patients. A second aim was to compare any anabolic response to that of healthy participants completing the same program.<h4>Methods</h4>In a single blind controlled study, 23 haemodialysis ...[more]

PMID: 24710697

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Project description: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.

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:The prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder.The study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial.There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression.ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.

Project description:BACKGROUND:Frailty is a state of low physiological reserve and multi-systemic dysregulation that leads to susceptibility to external stressors; it is associated with adverse outcomes. North American data suggest that haemodialysis recipients are more likely to be frail than the general population, although data on UK cohorts are lacking. Furthermore, with a multitude of assessment tools, it is difficult for the clinician to ascertain which is most suitable for this population. The FITNESS Study aims to measure the prevalence and outcomes associated with frailty in a large UK haemodialysis cohort to determine the optimum frailty tool as defined by predictive value for mortality/hospitalisation and to conduct a feasibility study exploring a multi-disciplinary clinical intervention to improve frailty among haemodialysis recipients. METHODS/DESIGN:The study will follow a cohort multiple randomised controlled trial design; the initial cohort study will identify participants to be invited into a subsequent open-label randomised controlled trial. Eligible patients will be identified and recruited from their usual haemodialysis session. They will be invited to complete tasks and questionnaires collecting data on sarcopenia, immunosenescence, mood, cognition, disability, and comorbidity. Fifty pre-frail participants with suitable English proficiency will be randomly selected from this cohort to participate in the randomised controlled trial phase of the study. Further stratified randomisation will occur to assign these 50 participants to active or passive groups. The active group will receive a psychologically supported, patient-centred, multi-disciplinary intervention into frailty, in what we believe to be a first within this patient group. The control group will receive usual haemodialysis standard of care. All participants will be followed up using electronic patient records for outcomes to include hospitalisation and mortality. Primary outcomes for this phase of the study will be feasibility and tolerability of the clinical intervention study. DISCUSSION:The study will collect data on multiple aspects of frailty allowing for a rich dataset for detailed analysis. We believe this will be the first study to explore a psychologically supported, patient-centred intervention in this patient group. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03071107 . Registered on 6 March 2017.

Project description:After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke.This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (?20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained.Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events.This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

Project description:Aims and objectivesTo develop a smartphone application-based dietary self-management program for haemodialysis patients and to examine its effects on biochemical indicators, self-efficacy and quality of life.BackgroundLack of dietary management in haemodialysis patients can lead to serious complications such as oedema, hyponatremia, hyperkalaemia, hypertension, uraemia and eventually death; however, studies using smartphone applications for dietary self-management in haemodialysis patients are rare.DesignA prospective, single-blind, randomised, controlled design with repeated measures was followed with 75 haemodialysis patients at a haemodialysis centre. Data were collected from 10 January 2017-6 May 2018. The study applied the Consolidated Standards of Reporting Trials statement.MethodsThe 8-week smartphone application-based dietary self-management program was developed through collaboration with a haemodialysis equipment company. The experimental group took this program while the control group took an 8-week general program. Study variables were serum phosphorus, potassium and albumin, self-efficacy and quality of life. They were measured at pretest, and 8 weeks and 12 weeks after the programs, and analysed using two-way repeated measures analysis of variance.FindingsThe smartphone application-based program significantly improved serum phosphorus, potassium, self-efficacy and quality of life over time compared with the general program. There was no significant difference in albumin level changes between the groups.ConclusionsThe smartphone application-based dietary self-management program is an opportune and effective nursing intervention to lower serum phosphorus and potassium levels in haemodialysis patients over time. Trial registration was performed on www.cris.nih.go.kr (KCT0005366).Relevance to clinical practiceHaemodialysis patients can easily use the smartphone application to manage their diet anytime and anywhere. They can get real-time feedback and solutions to prevent haemodialysis complications. Nurses can provide tailored high-quality care based on an individual's lifelog data from the smartphone application.

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Anabolic exercise in haemodialysis patients: a randomised controlled pilot study.

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Anabolic exercise in haemodialysis patients: a randomised controlled pilot study.

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