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
| ISRCTN | ISRCTN83508514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83508514 |
| ClinicalTrials.gov number | NCT02222402 |
| Secondary identifying numbers | HTA 12/23/09 |
- Submission date
- 11/12/2014
- Registration date
- 17/12/2014
- Last edited
- 24/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Hemodialysis is a form of treatment that replicates many of the kidney’s functions, filtering the blood to rid the body of harmful waste, extra salt, and water. The aim of this study is to test whether exercise carried out during hemodialysis benefits patients in terms of their general wellbeing and quality of life and also if it benefits physical function and ability to participate in daily activities, like walking and rising from a chair. The effects of participation in the exercise programme on other aspects that may be important to the health of hemodialysis patients (for example, blood pressure) will also be examined. In addition, we will also examine whether this type of additional treatment option is cost effective within the health service setting.
Who can participate?
Adult patients from dialysis units throughout the UK will participate in this study.
What does the study involve?
Once patients have agreed to take part they will complete a series of assessments to measure their quality of life and functional limitations. After this, patients will be allocated to either a usual care haemodialysis plus exercise group or a usual care haemodialysis group. The exercise group will receive the opportunity to exercise during their dialysis for a total duration of 6 months. All patients will be invited to come back for reassessment of quality of life and functional limitations after 6, 9 and 15 months.
What are the possible benefits and risks of participating?
The benefits of undertaking exercise training are that the patients are likely to feel better and healthier, have a potentially improved cardiovascular health, have improved physical, mental and emotional wellbeing, and an improved dialysis efficiency. All participants will have access to additional monitoring not available as part of routine care. For example, fitness and the health of blood vessels will be assessed. After the study patients will be able to use this information to guide their lifestyle choices, potentially impacting positively upon their health. For patients in the exercise group, there is a very small chance of getting a muscle strain or some joint pain following exercise. Also, blood sugar levels and blood pressure may drop during the exercise, which may make the patient feel sick or dizzy. Rarely, exercise can cause a change to heart function. To reduce the risks of exercise the patients’ medical history will be checked to ensure that health risks do not outweigh any benefits.
Where is the study run from?
King's College Hospital, Salford Royal Hospital, Glasgow Western Infirmary, Royal Derby Hospital and Heartlands Hospital (UK).
When is the study starting and how long is it expected to run for?
January 2015 to February 2020
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).
Who is the main contact?
Mrs Claire White (clairewhite4@nhs.net)
Professor Iain Macdougall (iain.macdougall@nhs.net)
Contact information
Public
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)2032999000 |
|---|---|
| clairewhite4@nhs.net |
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)2032999000 |
|---|---|
| iain.macdougall@nhs.net |
Study information
| Study design | Multi-centre pragmatic single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | PrEscription of intra-Dialytic exercise to improve quAlity of Life in patients with chronic kidney disease (PEDAL) |
| Study acronym | PEDAL |
| Study objectives | To determine, in comparison to usual care, whether usual care augmented by intra-dialytic exercise training improves health-related quality of life in stage 5 CKD patients receiving maintenance haemodialysis renal replacement therapy. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/122309 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/130659/PRO-12-23-09.pdf |
| Ethics approval(s) | London – Fulham, 27/11/2014, ref: 14/LO/1851 |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Once patients have agreed to take part they will complete a series of assessments to measure their self-reported QOL and functional limitations. After this, patients will be allocated to either a usual care haemodialysis plus intradialytic exercise group or a usual care haemodialysis group. The exercise group will receive the opportunity to exercise during their dialysis for a total duration of 6 months. All patients will be invited to come back for reassessment of QOL and functional limitations after 6, 9 and 15 months. |
| Intervention type | Mixed |
| Primary outcome measure | 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. |
| Secondary outcome measures | Assessed at 6, 9 and 15 months. Change between baseline and follow-up for: 1. KDQOL-PCS 2. KDQOL-MCS 3. KDQOL-Vitality subscale 4. KDQOL- symptom burden subscale 5. IPAQ 6. Height (at screening visit only), weight and anthropometric (BMI, waist to hip ratio) 7. Peak aerobic capacity 8. Duke Activity Status Index (self-report 12-item activity of daily living questionnaire) 9. 10 m Timed-up-and-go (composite test of leg strength, balance, coordination and gait speed) 10. Sit-to-stand 60 (proxy measure of lower extremity muscular endurance) 11. Tinetti Falls Efficacy Scale 12. Habitual physical activity (a self-report assessment via International Physical Activity Questionnaire) 13. Habitual physical activity (GT3X tri-axial accelerometer) 14. Arterial stiffness (via pulse wave velocity and augmentation index) 15. Blood pressure 16. Blood lipid levels – LDL, HDL, triglyceride levels 17. Hb 18. ESAs 19. HBA1c 20. CRP 21. Bicarbonate 22. Phosphate 23. Parathyroid hormone (PTH) 24. Dialysis efficiency 25. Change in medication use (vascular and diabetic medications) 26. EQ-5D, a generic multi-attribute health-related QOL questionnaire for use in cost-utility analysis 27. Health Economic questionnaire regarding resource use 28. All hospitalisations 29. All-cause mortality 30. Cardiovascular mortality 31. Safety/harms (AE, SAE) |
| Overall study start date | 31/07/2014 |
| Completion date | 29/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| Total final enrolment | 380 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Salford
M6 8HD
United Kingdom
Glasgow
G11 6NT
United Kingdom
Derby
DE22 3NE
United Kingdom
Birmingham
B9 5SS
United Kingdom
Sponsor information
Hospital/treatment centre
Denmark Hill
London
SE5 9RS
England
United Kingdom
"ROR" |
https://ror.org/01n0k5m85 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/09/2020 | 10/05/2021 | Yes | No | |
| Funder report results | 01/06/2021 | 24/06/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/06/2021: Publication reference added.
10/05/2021: Publication reference added.
12/06/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/07/2018 to 29/02/2020.
2. The intention to publish date and total final enrolment number were added.
15/04/2019: No publications found, verifying study status with principal investigator.
