Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Not Applicable

Completed

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Other: Exercise

• Registration Number: NCT03027778
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).

The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.

Recruitment of more participants in the future will be considered if warranted.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-11
• Study Completion: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment
• A cardiac evaluation was required within the last year to ensure adequate cardiac function

Exclusion Criteria

• Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia
• Serum intact parathyroid hormone(iPTH)>250 pmol/L within 30 days prior to screening visit
• Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment
• Severe peripheral arterial disease
• Severe hyperkalemia (>6.5 milliequivalent/L) consistently the last 2 weeks
• Current active cancer (excluding basal cell carcinoma of the skin)
• Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment
• Anticipated living donor kidney transplant or any other planned major surgery over the study duration
• History of poor treatment adherence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months.

Primary Outcome Measures

Name	Time	Method
Change in non-invasive measures of arterial stiffness using applanation tonometry.	4 months and 8 months after study initiation

Secondary Outcome Measures

Name	Time	Method
Change in gait speed using a 6 meter walk course and timer.	4 months and 8 months after study initiation
Change in grip strength using a hand dynamometer.	4 months and 8 months after study initiation
Safety and adverse events.	8 months