Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

Study Overview
=================
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.

Official Title
-----------------
Effects of Intra-dialytic Low-frequency Electrical Muscle Stimulation and Cycle Training on Cardiorespiratory Function and Muscular Strength: a Pilot Randomized Controlled Trial

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Other: Intra-dialytic LF-EMS
* Other: Intra-dialytic cycle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On haemodialysis for at least 3months On 3 times 4 hours of dialysis per week Urea reduction rate of at least 65% during the three months before enrolment Age 18 years or older Able to complete the exercise test and exercise training Able to provide informed consent Life expectancy of more than 6 months according to clinical assessment Exclusion Criteria: Clinically significant valvular insufficiency Clinically significant dysrythmia Uncontrolled blood pressure: systolic > 160, diastolic >95 during the months before enrolment 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 Haemoglobin unstable and below 9.0 Ischemic cardiac event or intervention in the last 3 months Clinically significant, still active inflammatory or malignant process Pacemaker or cardiac device (contraindicated for bioelectrical impedance) Planned kidney transplant during study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-dialytic LF-EMS<br>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). | Other: Intra-dialytic LF-EMS<br>* Electrical muscle stimulation during haemodialysis<br>* Other names: Electrical muscle stimulation;|
| Experimental: Intra-dialytic cycle training<br>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. | Other: Intra-dialytic cycle training<br>* Cycle training during haemodialysis<br>|
| No Intervention: Usual care<br>Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake (VO2peak) | Cardiopulmonary exercise test | Baseline, 10 weeks | 

Secondary Outcome Measures

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