Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

NCT ID: NCT02874521

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-09-30

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Intra-dialytic LF-EMS

Intervention Type: OTHER

Electrical muscle stimulation during haemodialysis

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.

Group Type: EXPERIMENTAL

Intra-dialytic cycle training

Intervention Type: OTHER

Cycle training during haemodialysis

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intra-dialytic LF-EMS

Electrical muscle stimulation during haemodialysis

Intervention Type: OTHER

Intra-dialytic cycle training

Cycle training during haemodialysis

Intervention Type: OTHER

Other Intervention Names

Electrical muscle stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Warwick Medical School

OTHER

Sponsor Role: collaborator

Cardiff Metropolitan University

OTHER

Sponsor Role: collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Godon S McGregor, PhD

Role: STUDY_CHAIR

UHCW NHS Trust

Locations

University Hospital

Coventry, , United Kingdom

Countries

United Kingdom

References

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/

Reference Type: BACKGROUND

PMID: 35077091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21975737 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26401465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12005153 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17900457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22236510 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

Other Identifiers

GM118313

Identifier Type: -

Identifier Source: org_study_id