Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

McGill University

Status

Completed

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03027778

12-309 GEN

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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