End-Stage Kidney Disease Clinical Trial
Official title:
Evaluating the Clinical and Cost-effectiveness of Intra-dialytic Exercise for the Improvement of Health-related Quality of Life in People With Stage 5 Chronic Kidney Disease Undergoing Maintenance Haemodialysis Renal Replacement Therapy.
The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise
training intervention designed to improve quality of life (QOL) and alleviate functional
limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.
Exercise rehabilitation will be compared against established treatment options available
within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the
experience and acceptability of the intervention for both participants and members of the
renal care team. In addition, we want to examine whether this type of additional exercise
treatment is cost effective within the health service setting.
PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380
adult patients who have been on HD for at least 3 months, from 10 HD sites located in
Scotland, England and Wales. The type of exercise programming will consist of cycling
exercise performed during each dialysis session plus a muscle conditioning programme
performed twice per week. All exercise sessions will be supervised by a physiotherapy
assistant. The exercise prescription will be individualised for all patients on the basis of
their fitness and clinical status.
The main objective is to examine the impact of exercise rehabilitation on quality of life and
well being of patients. We hypothesise that the exercise training delivered during
haemodialysis treatment will significantly improve the functional limitations/abilities of
the patients leading to the detection of clinically beneficial improvement in quality of life
outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.
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