Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

August 17, 2016 updated by: University Hospitals Coventry and Warwickshire NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Other: Intra-dialytic LF-EMS
Electrical muscle stimulation during haemodialysis
Other Names:
  • Electrical muscle stimulation
EXPERIMENTAL: 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.
Other: Intra-dialytic cycle training
Cycle training during haemodialysis
NO_INTERVENTION: Usual care
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)
Time Frame: Baseline, 10 weeks
Cardiopulmonary exercise test
Baseline, 10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborators

Cardiff Metropolitan University
Warwick Medical School

Investigators

  • Study Chair: Godon S McGregor, PhD, UHCW NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (ESTIMATE)

August 22, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM118313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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