Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

NCT ID: NCT03027778

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-01-31

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months

Usual care

Participants receive their usual dialysis for the duration of 4 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stella Daskalopoulou

Associate Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stella S Daskalopoulou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

References

Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

Cooke AB, Ta V, Iqbal S, Gomez YH, Mavrakanas T, Barre P, Vasilevsky M, Rahme E, Daskalopoulou SS. The Impact of Intradialytic Pedaling Exercise on Arterial Stiffness: A Pilot Randomized Controlled Trial in a Hemodialysis Population. Am J Hypertens. 2018 Mar 10;31(4):458-466. doi: 10.1093/ajh/hpx191.

Reference Type: DERIVED

PMID: 29126178 (View on PubMed)

Other Identifiers

12-309 GEN

Identifier Type: -

Identifier Source: org_study_id