INTRA-DIALYTIC EXERCISE IN RENAL FAILURE
Research type
Research Study
Full title
PrEscription of intraDialytic exercise to improve quAlity of Life (PEDAL Trial) in patients with chronic kidney disease
IRAS ID
162002
Contact name
Sharlene Greenwood
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
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. Other secondary outcomes include mental health, physical fitness and functional limitations, habitual physical activity and cardiovascular health outcomes. All assessments will be performed at baseline, 6, 9 and 15 months follow-up.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1851
Date of REC Opinion
27 Nov 2014
REC opinion
Further Information Favourable Opinion