Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02874521
Other study ID # GM118313
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT02922361 - Spending and Outcomes for Complex Medicare Advantage Patients
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01922843 - A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis Phase 2
Completed NCT01930396 - Use of Tinzaparin for Anticoagulation in Hemodialysis Phase 4
Not yet recruiting NCT01674660 - Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients N/A
Completed NCT01209403 - Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients Phase 4
Not yet recruiting NCT01157260 - The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease Phase 4
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Completed NCT00528788 - How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis Phase 4
Completed NCT00534144 - Comparison Between Effects of Two Iron Preparations on Protein in the Urine Phase 1
Completed NCT00226902 - Vascular Reactivity in Kidney Disease Patients N/A
Completed NCT00382044 - Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients N/A
Recruiting NCT00235287 - Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease Phase 4
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00071214 - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis Phase 3
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00006297 - Risk Factors for CV Disease in a Dialysis Cohort N/A