Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis - Full Text View

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00492362

Purpose

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	Intervention
Kidney Failure, Chronic	Behavioral: ergometer exercise during hemodialysis Behavioral: pedometer activity outside of hemodialysis

MedlinePlus related topics: Dialysis Exercise and Physical Fitness Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

quality of life measured by SF36 [ Time Frame: 3 and 6 months ]
dialysis adequacy as measured by ktV [ Time Frame: 3 and 6 months ]

Enrollment:	60
Study Start Date:	July 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Ergometer during hemodialysis	Behavioral: ergometer exercise during hemodialysis
B: Active Comparator Pedometer use outside of hemodialysis	Behavioral: pedometer activity outside of hemodialysis

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492362

Locations

Canada, Manitoba
Sherbrook Dialysis Unit
Winnipeg, Manitoba, Canada, R3A1M2
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Central Dialysis Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator:

Clara J Bohm, MD

University of Manitoba; Manitoba Renal Program

More Information

Study ID Numbers:	B2007:067
Study First Received:	June 26, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00492362
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

hemodialysis
exercise
physical fitness
dialysis adequacy

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009