Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Other: Intra-dialytic cycle training; Other: Intra-dialytic LF-EMS

• Registration Number: NCT02874521
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-22
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-dialytic cycle training	Intra-dialytic cycle training	Semi-recumbent cycling performed twice weekly whilst seated on a standard dialysis chair. Performed for up to one hour per session, initially at a workload (Watts) equivalent to that achieved at 40-60% VO2 reserve during cardiopulmonary exercise test. Exercise intensity regulated using a combination of heart rate and rating of perceived exertion (12-14). Workload adjusted weekly and controlled with a combination of pedal resistance and cadence to provide a personalised exercise prescription. Five minute warm-up and cool down each session.
Intra-dialytic LF-EMS	Intra-dialytic LF-EMS	Performed twice weekly whilst seated on a standard dialysis chair. Delivered by adhesive electrodes in a neoprene garment, applied bilaterally to the quadriceps and hamstrings. Cardiovascular stimulus via rapid, rhythmical, sub-tetanic contractions. Short bursts of four pulses repeatedly delivered by stimulator at a frequency of 4Hz. Current amplitude adjustable from 40 - 200 mA with inbuilt controller. Conducted for one hour at the maximum tolerable intensity. Five minute warm-up and cool down at a lower frequency (3 Hz).

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2peak)	Baseline, 10 weeks	Cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Muscular strength	Baseline, 10 weeks	Hand held dynamometer - quadriceps strength
Arterial remodelling	Baseline, 10 weeks	Tonometry - pulse wave velocity
Health related quality of life	Baseline, 10 weeks	Questionnaire - KDQOL-36
Cardiac remodelling	Baseline, 10 weeks	Echocardiography - left ventricular volumes

Trial Locations

Locations (1)

University Hospital; 🇬🇧 Coventry, United Kingdom