Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874521
• Other study ID #: GM118313
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 17, 2016
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• Intra-dialytic LF-EMS
Electrical muscle stimulation during haemodialysis
• Intra-dialytic cycle training
Cycle training during haemodialysis

Locations

Country	Name	City	State
United Kingdom	University Hospital	Coventry

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	Cardiff Metropolitan University, Warwick Medical School

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. Review. — View 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. — View Citation

Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD003236. doi: 10.1002/14651858.CD003236.pub2. Review. — View 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. — View 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. Review. — View Citation

The National Institute for Health and Care Excellence (NICE). Guideline CG73. Chronic KIdney Disease.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake (VO2peak)	Cardiopulmonary exercise test	Baseline, 10 weeks	No
Secondary	Muscular strength	Hand held dynamometer - quadriceps strength	Baseline, 10 weeks	No
Secondary	Arterial remodelling	Tonometry - pulse wave velocity	Baseline, 10 weeks	No
Secondary	Cardiac remodelling	Echocardiography - left ventricular volumes	Baseline, 10 weeks	No
Secondary	Health related quality of life	Questionnaire - KDQOL-36	Baseline, 10 weeks	No