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Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00492362
First received: June 26, 2007
Last updated: June 2, 2008
Last verified: June 2008

June 26, 2007
June 2, 2008
July 2007
May 2008   (final data collection date for primary outcome measure)
  • Aerobic exercise capacity as measured by VO2 peak [ Time Frame: 3 and 6 months ]
  • physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test [ Time Frame: 3 and 6 months ]
Same as current
Complete list of historical versions of study NCT00492362 on ClinicalTrials.gov Archive Site
  • quality of life measured by SF36 [ Time Frame: 3 and 6 months ]
  • dialysis adequacy as measured by ktV [ Time Frame: 3 and 6 months ]
Same as current
Not Provided
Not Provided
 
Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Kidney Failure, Chronic
  • Behavioral: ergometer exercise during hemodialysis
  • Behavioral: pedometer activity outside of hemodialysis
  • Active Comparator: A
    Ergometer during hemodialysis
    Intervention: Behavioral: ergometer exercise during hemodialysis
  • Active Comparator: B
    Pedometer use outside of hemodialysis
    Intervention: Behavioral: pedometer activity outside of hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00492362
B2007:067
Yes
Not Provided
University of Manitoba
Not Provided
Principal Investigator: Clara J Bohm, MD University of Manitoba; Manitoba Renal Program
University of Manitoba
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP