The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT01877863
Collaborator
(none)
50
1
1

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: intradialytic exercise

baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program

Other: exercise
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
Other Names:
  • intradialytic exercise
  • intradialytic biking
  • biking on hemodialysis
  • Outcome Measures

    Primary Outcome Measures

    1. Functional Capacity [12 weeks]

      Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.

    Secondary Outcome Measures

    1. Aerobic capacity [12 weeks]

      Aerobic capacity is measured as a function of the DASI score

    2. Strength [12 weeks]

      Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds). These measures are obtained at baseline and again at 12 weeks.

    3. Quality of life [12 weeks]

      The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.

    4. Hospitalizations [12 weeks]

      The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program. Length of stay is also tracked.

    5. Hypotension [12 weeks]

      Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg. IDH with patient symptoms and nursing interventions will be obtained as well.

    6. Hemoglobin levels [12 weeks]

      The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.

    7. Potassium levels [12 weeks]

      The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.

    8. Urea removal [12 weeks]

      The baseline and 12 week pre and post dialysis urea levels will be monitored.

    9. Phosphate levels [12 weeks]

      The baseline and 12 week pre-dialysis phosphate levels will be tracked.

    10. Bioimpedance derived volume and body mass determinations [12 weeks]

      In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Cardiac and hemodynamic stability

    • Absence of severe musculoskeletal impairment

    • Increased musculoskeletal weakness

    • Vital signs within normal range for exercise

    • Desire/motivated to exercise

    • Clearance from nephrologist and Kinesiologist

    Exclusion Criteria:
    • Compromised cardiac profiles

    • Hemodynamic instability

    • Severe bone disease

    • Medical conditions which contraindicate exercise

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwest Dialysis Centre Calgary Alberta Canada T2L 2J8

    Sponsors and Collaborators

    • University of Calgary

    Investigators

    • Principal Investigator: Jennifer MacRae, University of Calgary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Jennifer MacRae, Principal Investigator, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT01877863
    Other Study ID Numbers:
    • E-25253
    First Posted:
    Jun 14, 2013
    Last Update Posted:
    Mar 20, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Dr Jennifer MacRae, Principal Investigator, University of Calgary
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 20, 2014