Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

June 2, 2008 updated by: University of Manitoba

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aerobic exercise capacity as measured by VO2 peak
Time Frame: 3 and 6 months
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
3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Clara J Bohm, MD, University of Manitoba; Manitoba Renal Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2007:067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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