NCT02222402

PrEscription of Intra-Dialytic Exercise to Improve quAlity of Life in Patients With Chronic Kidney Disease

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• End-Stage Kidney Disease

Interventions

Type	Name	Description
BEHAVIORAL	INTRA-DIALYTIC EXERCISE TRAINING

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-08-21
• Last updated: 2020-02-28

Locations

1 site across 1 country: United Kingdom