Recipient organisationKing's College Hospital NHS Foundation Trust
Funding£1.4M
PeriodApr 2014 — Feb 2020
In plain English
AI plain-English summary
Patients on kidney dialysis will pedal exercise bikes during their treatment sessions to see if this improves their quality of life and physical function. The problem: People with stage 5 chronic kidney disease on haemodialysis often suffer from poor physical fitness, reduced mobility, and low quality of life. Exercise during dialysis—intradialytic exercise—could help, but the NHS lacks robust evidence on whether it works and is cost-effective. The PEDAL trial is a pragmatic, multicentre randomised controlled trial across England, Wales, and Scotland that will test a 9-month programme of thrice-weekly cycling plus twice-weekly leg-strengthening exercises, supervised by physiotherapy assistants, against standard care alone. If the trial shows that intradialytic exercise meaningfully improves patients’ physical composite scores on the Kidney Disease Quality of Life-36 questionnaire—where even a 1-point increase is linked to reduced hospitalisation and mortality—the NHS could adopt this as a routine, low-cost intervention. That would directly change how thousands of dialysis patients spend their treatment hours, potentially improving their daily lives without requiring extra clinic visits. The nested health economic analysis will tell funders whether the programme is worth scaling.
View original technical description
The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise training intervention designed to improve quality of life (QOL) and functional limitations in patients with stage 5 CKD, against established treatment options available within UK NHS haemodialysis (HD)units. It is designed as a pragmatic, multicentre RCT (with an internal pilot study) with two treatment arms: intradialytic exercise training plus usual care maintenance HD (EXHD) versus usual care maintenance HD (UCHD). The internal pilot, run concurrently with the main trial, will explore patient participation metrics and intervention acceptability in a sample of 20% of patients. Within the RCT, a nested qualitative study will also investigate the experience and acceptability of the intervention for both participants and members of the renal care team. Health Economic analysis will be conducted to assess the cost effectiveness of the intervention. We propose to recruit participants to the PEDAL study from all adult eligible prevalent HD patients who have been receiving outpatient maintenance HD for at least 3 months. We propose to recruit participants to the PEDAL study from all eligible adult prevalent intra-dialytic exercise naïve HD patients receiving outpatient maintenance HD for at least 3 months. Patients will be recruited from hospital HD units. Recruitment for the trial will take place over a 21-month period in HD units from England, Wales and Scotland. Intradialytic exercise is the Health Technology being assessed. The type of exercise programme advocated is a combination of thrice weekly aerobic cycle exercise and twice weekly muscular endurance conditioning. The aerobic exercise involves steady, rhythmic movements of the large muscle groups of the body. In this instance it will be accomplished by pedalling at a preset cadence against a frictional resistance applied by a cycle ergometer specially adapted for dialysis chairs/couches. The aerobic exercise will be performed seated, in a semi-recumbent position, during the first two hours of haemodialysis. Twice per week and immediately after the aerobic cycling exercise, patients will also complete lower extremity muscular conditioning exercise, using ankle weights. These ankle weights are fitted with a Velcro strap attachment and of a type routinely used by NHS physiotherapists. All intradialytic exercise sessions will be supervised by a Physiotherapy Assistant. The aerobic exercise prescription will be individualised for all patients on the basis of a peak aerobic capacity assessment conducted during an incremental exercise test on a stationary cycle ergometer. Participants will have their QOL, functional limitations and selected clinical characterstics recorded via blinded outcome assessment prior to treatment randomisation and followed up after 6, 9 and 15 months. Following blinded outcome assessments conducted at entry to the study, a total of 380 patients will be randomised equally in 5 centres to either UCHD or EXHD, giving 190 per treatment arm. Based on evidence from phase II trials (23) we expect 17-25% of patients to discontinue the exercise programme due to transplant, death or personal choice over the 9 months of the programme. A similar discontinuation rate will occur in the UCHD group, leading to 133 patients per group completing the study. The primary outcome will be change in the Kidney Disease Quality of Life-36 (KDQOL-36) Physical Composite Score (PCS) and this will be evaluated at the primary endpoint after 6 months of the intervention. Based on the PCS variability seen in Painter et al (31) and comparing 6-month KDQOL PCS between groups by two sample t-test (two-sided 5% significance level), this sample size would give 83% power to detect a mean difference of 4 points in KDQOL PCS. The 4 point effect size is of clinical relevance: as there is an established relationship between each 1 point increase in PCS and reduced mortality and hospitalisation (9). Important se
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