Kidney Failure, Chronic
Conditions
Brief summary
The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise training.
Detailed description
End stage renal disease is associated with reduced functional capacity. Dynamic exercise training i.e. cycling, performed between dialysis sessions or during dialysis (intra-dialytic) can be effective in improving functional capacity and quality of life. However, many patients are unable to engage in intra-dialytic cycling due to limiting comorbidities. Other exercise modalities should be considered. Low-frequency electrical muscle stimulation of the quadriceps is well tolerated and may improve functional capacity in clinical populations. The trial is a longitudinal, randomised controlled trial. Participants will be randomly allocated to 10 weeks of 1) intra-dialytic low-frequency electrical muscle stimulation, 2) intra-dialytic cycling, or 3) usual care haemodialysis without exercise training. Outcomes will be assessed at baseline and 10 weeks by assessors blinded to group allocation.
Interventions
OTHERIntra-dialytic LF-EMS
Electrical muscle stimulation during haemodialysis
OTHERIntra-dialytic cycle training
Cycle training during haemodialysis
Sponsors
Warwick Medical School
Cardiff Metropolitan University
University Hospitals Coventry and Warwickshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. On haemodialysis for at least 3months 2. On 3 times 4 hours of dialysis per week 3. Urea reduction rate of at least 65% during the three months before enrolment 4. Age 18 years or older 5. Able to complete the exercise test and exercise training 6. Able to provide informed consent 7. Life expectancy of more than 6 months according to clinical assessment
Exclusion criteria
1. Clinically significant valvular insufficiency 2. Clinically significant dysrythmia 3. Uncontrolled blood pressure: systolic \> 160, diastolic \>95 during the months before enrolment 4. Excessive fluid accumulation between dialysis sessions (\>3 liters), more than twice pulmonary edema over 3 months before enrolment deemed to be due to excess fluid intake 5. Haemoglobin unstable and below 9.0 6. Ischemic cardiac event or intervention in the last 3 months 7. Clinically significant, still active inflammatory or malignant process 8. Pacemaker or cardiac device (contraindicated for bioelectrical impedance) 9. Planned kidney transplant during study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen uptake (VO2peak) | Baseline, 10 weeks | Cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular strength | Baseline, 10 weeks | Hand held dynamometer - quadriceps strength |
| Arterial remodelling | Baseline, 10 weeks | Tonometry - pulse wave velocity |
| Cardiac remodelling | Baseline, 10 weeks | Echocardiography - left ventricular volumes |
| Health related quality of life | Baseline, 10 weeks | Questionnaire - KDQOL-36 |
Countries
United Kingdom
Outcome results
None listed