Kidney Failure, ChronicNCT02874521
Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis
A study testing Intra-dialytic LF-EMS and Intra-dialytic cycle training in people with Kidney Failure, Chronic, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Intra-dialytic LF-EMS and Intra-dialytic cycle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Clinically significant, still active inflammatory or malignant process
- Pacemaker or cardiac device (contraindicated for bioelectrical impedance)
- Planned kidney transplant during study period.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Intra-dialytic LF-EMS, Intra-dialytic cycle training
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-dialytic LF-EMSOther
Also called Electrical muscle stimulation
Electrical muscle stimulation during haemodialysis
Intra-dialytic cycle trainingOther
Cycle training during haemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Intra-dialytic LF-EMS | Experimental | 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). Receives: Other: Intra-dialytic LF-EMS |
| Intra-dialytic cycle training | Experimental | 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. Receives: Other: Intra-dialytic cycle training |
| Usual care | No intervention | Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak)
Cardiopulmonary exercise test
Measured: Baseline, 10 weeks
Secondary outcomes (4)
Muscular strength
Hand held dynamometer - quadriceps strength
Measured: Baseline, 10 weeks
Arterial remodelling
Tonometry - pulse wave velocity
Measured: Baseline, 10 weeks
Cardiac remodelling
Echocardiography - left ventricular volumes
Measured: Baseline, 10 weeks
Health related quality of life
Questionnaire - KDQOL-36
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Medical School, Cardiff Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Godon S McGregor, PhD, Study chair, UHCW NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874521
- Sponsor's protocol ID
- GM118313
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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/
PubMed 35077091Heiwe 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.
PubMed 21975737Bowen 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.
PubMed 26401465Koufaki 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.
PubMed 12005153Cheema 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.
PubMed 17900457Smart 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.
PubMed 22236510Bernier-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.
PubMed 35018639
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02874521
- Acronym / sponsor ID
- GM118313
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Warwick Medical School, Cardiff Metropolitan University
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra-dialytic LF-EMS | Experimental | Other: Intra-dialytic LF-EMSPerformed 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). |
| Intra-dialytic cycle training | Experimental | Other: Intra-dialytic cycle trainingSemi-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. |
| Usual care | No intervention | –Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-dialytic LF-EMSAlso: Electrical muscle stimulationElectrical muscle stimulation during haemodialysis | Other | Intra-dialytic LF-EMS |
| Intra-dialytic cycle trainingCycle training during haemodialysis | Other | Intra-dialytic cycle training |
Primary outcome
Peak oxygen uptake (VO2peak)
Time frame: Baseline, 10 weeks
Cardiopulmonary exercise test
4 secondary outcomes
Muscular strength
Time frame: Baseline, 10 weeks
Arterial remodelling
Time frame: Baseline, 10 weeks
Cardiac remodelling
Time frame: Baseline, 10 weeks
Health related quality of life
Time frame: Baseline, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 350770912021 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/
- Background: PubMed 21975737Heiwe 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.
- Background: PubMed 26401465Bowen 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.
- Background: PubMed 12005153Koufaki 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.
- Background: PubMed 17900457Cheema 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.
- Background: PubMed 22236510Smart 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.
- Derived from this study: PubMed 35018639Bernier-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Godon S McGregor, PhD study chair
UHCW NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-dialytic LF-EMS and Intra-dialytic cycle training in people with Kidney Failure, Chronic, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2peak) (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874521, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.