Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

NCT03027778 | Completed DMC

• 1 other identifier: 12-309 GEN
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

arterial stiffness; hemodialysis; intradialytic pedalling exercise; carotid-femoral pulse wave velocity; chronic kidney disease; hemodynamics; augmentation index

Outcome Measures

Primary Outcomes (1)

• Change in non-invasive measures of arterial stiffness using applanation tonometry.

  4 months and 8 months after study initiation

Secondary Outcomes (3)

• 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

Other Outcomes (12)

• Change in peripheral and central blood pressure using a oscillometric cuff-based approach.

  4 months and 8 months after study initiation

• Change in total cholesterol levels

  4 months and 8 months after study initiation

• Change in triglyceride levels

  4 months and 8 months after study initiation

Study Arms (2)

Exercise

EXPERIMENTAL

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

Other: Exercise

Usual care

NO INTERVENTION

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

Interventions

Exercise OTHER

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

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Related Publications (2)

• 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.

  PMID: 35018639 DERIVED

• 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.

  PMID: 29126178 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stella S Daskalopoulou, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Medicine

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share