Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

Sponsor

University of Manitoba (Other)

Overall Status

Completed

CT.gov ID

NCT00492362

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aerobic exercise capacity as measured by VO2 peak [3 and 6 months]
physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test [3 and 6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sherbrook Dialysis Unit	Winnipeg	Manitoba	Canada	R3A1M2
2	Central Dialysis Unit, Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A1R9
3	Seven Oaks General Hospital	Winnipeg	Manitoba	Canada
4	St. Boniface General Hospital	Winnipeg	Manitoba	Canada