Condition category
Urological and Genital Diseases
Date applied
11/12/2014
Date assigned
17/12/2014
Last edited
17/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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?
The study will run from January 2015 to July 2018.

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)

Trial website

Contact information

Type

Public

Primary contact

Mrs Claire White

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)2032999000
clairewhite4@nhs.net

Type

Scientific

Additional contact

Professor Iain Macdougall

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)2032999000
iain.macdougall@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02222402

Protocol/serial number

HTA 12/23/09

Study information

Scientific title

PrEscription of intra-Dialytic exercise to improve quAlity of Life in patients with chronic kidney disease (PEDAL)

Acronym

PEDAL

Study hypothesis

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

London – Fulham, 27/11/2014, ref:14/LO/1851

Study design

Multi-centre pragmatic single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

31/07/2014

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant 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

Recruitment start date

01/01/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Glasgow Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter New Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Trust

Sponsor details

Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes