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Completed

NCT Number: NCT02874521

Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-dialytic LF-EMS

Other

Electrical muscle stimulation during haemodialysis

Other names: Electrical muscle stimulation

Intra-dialytic cycle training

Other

Cycle training during haemodialysis

Primary outcomes

  1. Peak oxygen uptake (VO2peak)

    Time frame: Baseline, 10 weeks

    Cardiopulmonary exercise test

Secondary outcomes

  1. Muscular strength

    Time frame: Baseline, 10 weeks

    Hand held dynamometer - quadriceps strength

  2. Arterial remodelling

    Time frame: Baseline, 10 weeks

    Tonometry - pulse wave velocity

  3. Cardiac remodelling

    Time frame: Baseline, 10 weeks

    Echocardiography - left ventricular volumes

  4. Health related quality of life

    Time frame: Baseline, 10 weeks

    Questionnaire - KDQOL-36

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

  • Cardiff Metropolitan University
  • Warwick Medical School

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2016
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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