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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary
ClinicalTrials.gov Identifier:
NCT01877863
First received: May 27, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention
End Stage Kidney Disease
Other: exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Functional Capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Aerobic capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Aerobic capacity is measured as a function of the DASI score

  • Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.

  • Hospitalizations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Hypotension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Hemoglobin levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.

  • Potassium levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.

  • Urea removal [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The baseline and 12 week pre and post dialysis urea levels will be monitored.

  • Phosphate levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The baseline and 12 week pre-dialysis phosphate levels will be tracked.

  • Bioimpedance derived volume and body mass determinations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: May 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877863

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

No publications provided

Responsible Party: Dr Jennifer MacRae, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01877863     History of Changes
Other Study ID Numbers: E-25253
Study First Received: May 27, 2013
Last Updated: March 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
intradialytic exercise
hemodialysis

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

ClinicalTrials.gov processed this record on August 21, 2014