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Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-dialytic LF-EMS
Intra-dialytic cycle training
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intra-dialytic LF-EMS

Intra-dialytic cycle training

Usual care

Arm 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).

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.

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

Outcomes

Primary Outcome Measures

Peak oxygen uptake (VO2peak)
Cardiopulmonary exercise test

Secondary Outcome Measures

Muscular strength
Hand held dynamometer - quadriceps strength
Arterial remodelling
Tonometry - pulse wave velocity
Cardiac remodelling
Echocardiography - left ventricular volumes
Health related quality of life
Questionnaire - KDQOL-36

Full Information

First Posted
August 17, 2016
Last Updated
August 17, 2016
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Warwick Medical School, Cardiff Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02874521
Brief Title
Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Warwick Medical School, Cardiff Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-dialytic LF-EMS
Arm Type
Experimental
Arm 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).
Arm Title
Intra-dialytic cycle training
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention.
Intervention Type
Other
Intervention Name(s)
Intra-dialytic LF-EMS
Other Intervention Name(s)
Electrical muscle stimulation
Intervention Description
Electrical muscle stimulation during haemodialysis
Intervention Type
Other
Intervention Name(s)
Intra-dialytic cycle training
Intervention Description
Cycle training during haemodialysis
Primary Outcome Measure Information:
Title
Peak oxygen uptake (VO2peak)
Description
Cardiopulmonary exercise test
Time Frame
Baseline, 10 weeks
Secondary Outcome Measure Information:
Title
Muscular strength
Description
Hand held dynamometer - quadriceps strength
Time Frame
Baseline, 10 weeks
Title
Arterial remodelling
Description
Tonometry - pulse wave velocity
Time Frame
Baseline, 10 weeks
Title
Cardiac remodelling
Description
Echocardiography - left ventricular volumes
Time Frame
Baseline, 10 weeks
Title
Health related quality of life
Description
Questionnaire - KDQOL-36
Time Frame
Baseline, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Godon S McGregor, PhD
Organizational Affiliation
UHCW NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35077091
Citation
2021 exceptional surveillance of chronic kidney disease (NICE guideline NG203) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2021 Aug 25. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK576880/
Results Reference
background
PubMed Identifier
21975737
Citation
Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
Results Reference
background
PubMed Identifier
26401465
Citation
Bowen TS, Schuler G, Adams V. Skeletal muscle wasting in cachexia and sarcopenia: molecular pathophysiology and impact of exercise training. J Cachexia Sarcopenia Muscle. 2015 Sep;6(3):197-207. doi: 10.1002/jcsm.12043. Epub 2015 Jun 3.
Results Reference
background
PubMed Identifier
12005153
Citation
Koufaki P, Mercer TH, Naish PF. Effects of exercise training on aerobic and functional capacity of end-stage renal disease patients. Clin Physiol Funct Imaging. 2002 Mar;22(2):115-24. doi: 10.1046/j.1365-2281.2002.00405.x.
Results Reference
background
PubMed Identifier
17900457
Citation
Cheema B, Abas H, Smith B, O'Sullivan A, Chan M, Patwardhan A, Kelly J, Gillin A, Pang G, Lloyd B, Fiatarone Singh M. Randomized controlled trial of intradialytic resistance training to target muscle wasting in ESRD: the Progressive Exercise for Anabolism in Kidney Disease (PEAK) study. Am J Kidney Dis. 2007 Oct;50(4):574-84. doi: 10.1053/j.ajkd.2007.07.005.
Results Reference
background
PubMed Identifier
22236510
Citation
Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Epub 2012 Jan 10.
Results Reference
background
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived

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Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

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