Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Behavioral: ergometer exercise during hemodialysis
* Behavioral: pedometer activity outside of hemodialysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Ergometer during hemodialysis | Behavioral: ergometer exercise during hemodialysis<br> <br> |
| Active Comparator: B<br>Pedometer use outside of hemodialysis | Behavioral: pedometer activity outside of hemodialysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life measured by SF36 |  | 3 and 6 months | 
| dialysis adequacy as measured by ktV |  | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, exercise, physical fitness, dialysis adequacy