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Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population (NCT03027778)

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. Qualitative assessments will be conducted among participants to evaluate the acceptability, feasibility and sustainability of intradialytic pedalling exercise. Recruitment of more participants in the future will be considered if warranted.
  • Other: Exercise
    Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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
    Status:
    active not recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 January, 2015
    Updated:
    18 January, 2017
    Participants:
    40
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