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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01877863
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : March 20, 2014
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary

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
End Stage Kidney Disease Other: exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 2013
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Functional Capacity [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Aerobic capacity is measured as a function of the DASI score

  2. Strength [ Time Frame: 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 [ Time Frame: 12 weeks ]
    The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.

  4. Hospitalizations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.

  7. Potassium levels [ Time Frame: 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 [ Time Frame: 12 weeks ]
    The baseline and 12 week pre and post dialysis urea levels will be monitored.

  9. Phosphate levels [ Time Frame: 12 weeks ]
    The baseline and 12 week pre-dialysis phosphate levels will be tracked.

  10. Bioimpedance derived volume and body mass determinations [ Time Frame: 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.

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Ages Eligible for Study:   Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01877863

Canada, Alberta
Northwest Dialysis Centre
Calgary, Alberta, Canada, T2L 2J8
Sponsors and Collaborators
University of Calgary
Principal Investigator: Jennifer MacRae University of Calgary

Responsible Party: Dr Jennifer MacRae, Principal Investigator, University of Calgary Identifier: NCT01877863     History of Changes
Other Study ID Numbers: E-25253
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Dr Jennifer MacRae, University of Calgary:
intradialytic exercise

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency