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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital | Coventry |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust | Cardiff Metropolitan University, Warwick Medical School |
United Kingdom,
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.
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 |
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