Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Kidney Failure, Chronic

Treatments: Other: Intra-dialytic LF-EMS; Other: Intra-dialytic cycle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02874521

GM118313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

Intra-dialytic LF-EMS

Experimental group

Description:

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).

Treatment:

Other: Intra-dialytic LF-EMS

Intra-dialytic cycle training

Experimental group

Description:

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.

Treatment:

Other: Intra-dialytic cycle training

Usual care

No Intervention group

Description:

Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention.