Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

Kidney Failure, Chronic Clinical Trial

Official title:

A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492362
• Other study ID #: B2007:067
• Status: Completed
• Phase: N/A
• First received: June 26, 2007
• Last updated: June 2, 2008
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Behavioral:
• ergometer exercise during hemodialysis

• pedometer activity outside of hemodialysis

Locations

Country	Name	City	State
Canada	Central Dialysis Unit, Health Sciences Centre	Winnipeg	Manitoba
Canada	Seven Oaks General Hospital	Winnipeg	Manitoba
Canada	Sherbrook Dialysis Unit	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic exercise capacity as measured by VO2 peak		3 and 6 months
Primary	physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test		3 and 6 months
Secondary	quality of life measured by SF36		3 and 6 months
Secondary	dialysis adequacy as measured by ktV		3 and 6 months