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Completed

NCT Number: NCT03027778

Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

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

    Time frame: 4 months and 8 months after study initiation

Secondary outcomes

  1. Change in gait speed using a 6 meter walk course and timer.

    Time frame: 4 months and 8 months after study initiation

  2. Change in grip strength using a hand dynamometer.

    Time frame: 4 months and 8 months after study initiation

  3. Safety and adverse events.

    Time frame: 8 months

Other outcomes

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

    Time frame: 4 months and 8 months after study initiation

  2. Change in total cholesterol levels

    Time frame: 4 months and 8 months after study initiation

  3. Change in triglyceride levels

    Time frame: 4 months and 8 months after study initiation

  4. Change in high density lipoprotein cholesterol levels

    Time frame: 4 months and 8 months after study initiation

  5. Change in low-density lipoprotein cholesterol levels

    Time frame: 4 months and 8 months after study initiation

    Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels

  6. Change in hemoglobin levels

    Time frame: 4 months and 8 months after study initiation

  7. Change in leukocyte levels

    Time frame: 4 months and 8 months after study initiation

  8. Change in platelet levels

    Time frame: 4 months and 8 months after study initiation

  9. Change in albumin levels

    Time frame: 4 months and 8 months after study initiation

  10. Change in serum electrolyte levels

    Time frame: 4 months and 8 months after study initiation

  11. Change in phosphate levels

    Time frame: 4 months and 8 months after study initiation

  12. Change in ferritin levels

    Time frame: 4 months and 8 months after study initiation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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