Clinical value 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

Not Applicable

Completed

• Conditions: Chronic kidney disease; Urological and Genital Diseases

• Registration Number: ISRCTN83508514
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33959264/ (added 10/05/2021) 2021 report to funder in https://doi.org/10.3310/hta25400 (added 24/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Study Completion: 2020-02-29
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Prevalent Stage 5 CKD patients (GFR <15 mL/min) receiving maintenance haemodialysis therapy for more than 3 months
2. Male or female
3. Aged >18 years
4. Able to provide written informed consent

Exclusion Criteria

1. Patients unlikely to be on HD for > 6 months (this includes cachectic patients, those with severe heart failure, patients in whom dialysis withdrawal is being considered, and patients likely to receive a live-donor transplant or transfer to PD in that period of time)
2. Less than 3 months after the initiation of haemodialysis (patients in this time-frame are generally less clinically stable, many having vascular access procedures performed, and rates of inter-current events, including death and hospitalisation, are very much higher in the first 3 months after commencement of chronic haemodialysis)
3. Deemed to be clinically unstable by treating physician
4. Bilateral lower limb amputees
5. Dementia or severe cognitive impairment (as will be unable to give consent and/or complete questionnaire assessments)
6. Severe psychiatric disorders – except treated stable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in Kidney Disease QOL questionnaire Physical Composite Score (KDQOL-PCS) between baseline and 6 months. The KDQOL is a disease-specific quality of life measure.