Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

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: NCT00492362
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : June 4, 2008
Information provided by:
University of Manitoba

Brief Summary:
Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Behavioral: ergometer exercise during hemodialysis Behavioral: pedometer activity outside of hemodialysis Not Applicable

Detailed Description:

Study Design:

Prospective, randomized, controlled trial of chronic hemodialysis outpatients within the Manitoba Renal Program.

Potential patients include any individual receiving chronic outpatient hemodialysis in Winnipeg (Seven Oaks, Sherbrook, Central and St. Boniface dialysis units) and the Brandon hemodialysis unit.

Exercise Interventions:

Patients will be block randomized to one of the following 2 interventions:

Group A: Cycling on an ergometer GOAL 60 minutes 3 times per week on hemodialysis for 24 weeks A cycling ergometer will be placed on the floor in front of the patient's dialysis chair or at the foot of the bed (if there are only beds available in that unit). The patient will be allowed to exercise anytime during the first half of each dialysis treatment. Goal frequency will be 3 times per week during their usual scheduled hemodialysis treatments.

Group B: Pedometers This group will each receive a pedometer (StepsCount®) at the onset of the study following exercise testing. They will be educated regarding the technical use of the pedometer and will receive the handout entitled "Pedometer Information Sheet: Get Physically Active One Step at a Time!" They will also receive verbal education regarding use of the pedometer and goal activity levels from the exercise study supervisor.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Ergometer during hemodialysis
Behavioral: ergometer exercise during hemodialysis
Active Comparator: B
Pedometer use outside of hemodialysis
Behavioral: pedometer activity outside of hemodialysis

Primary Outcome Measures :
  1. Aerobic exercise capacity as measured by VO2 peak [ Time Frame: 3 and 6 months ]
  2. physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. quality of life measured by SF36 [ Time Frame: 3 and 6 months ]
  2. dialysis adequacy as measured by ktV [ Time Frame: 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All adult (>18 years old) patients
  • Treated with hemodialysis for > 3 months
  • Hemoglobin > 100 g/L over the previous 2 months
  • Kt/V > 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
  • Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.

Exclusion Criteria:

  • Acute medical illness in last month
  • Unstable hemodialysis with frequent hypotension over the past month
  • Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
  • Lower extremity amputation with no prosthesis (inability to pedal a bike)
  • Spine compression fractures
  • Severe musculoskeletal pain at rest or with minimal activity
  • Inability to sit, stand or walk unassisted (walking devices such as cane will be allowed)
  • Shortness of breath at rest or with activities of daily living (NYHA Class IV)
  • Labile glycemic control with hypoglycaemic episodes > 1x/week.

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): NCT00492362

Canada, Manitoba
Sherbrook Dialysis Unit
Winnipeg, Manitoba, Canada, R3A1M2
Central Dialysis Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Principal Investigator: Clara J Bohm, MD University of Manitoba; Manitoba Renal Program Identifier: NCT00492362     History of Changes
Other Study ID Numbers: B2007:067
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by University of Manitoba:
physical fitness
dialysis adequacy

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