Clinical trial NCT02874521: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: Warwick Medical School
name: Cardiff Metropolitan University
First posted: 2016-08-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Peak oxygen uptake (VO2peak)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Muscular strength
timeFrame: Baseline, 10 weeks
measure: Arterial remodelling
timeFrame: Baseline, 10 weeks
measure: Cardiac remodelling
timeFrame: Baseline, 10 weeks
measure: Health related quality of life
timeFrame: Baseline, 10 weeks
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospital
Study officials:
affiliation: UHCW NHS Trust
name: Godon S McGregor, PhD
role: STUDY_CHAIR
References:
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/
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.
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.
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.
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.
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.
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.