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Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ergometer exercise during hemodialysis
pedometer activity outside of hemodialysis
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Failure, Chronic focused on measuring hemodialysis, exercise, physical fitness, dialysis adequacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sherbrook Dialysis Unit
  • Central Dialysis Unit, Health Sciences Centre
  • Seven Oaks General Hospital
  • St. Boniface General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Ergometer during hemodialysis

Pedometer use outside of hemodialysis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

quality of life measured by SF36
dialysis adequacy as measured by ktV

Full Information

First Posted
June 26, 2007
Last Updated
June 2, 2008
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00492362
Brief Title
Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
Official Title
A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
hemodialysis, exercise, physical fitness, dialysis adequacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Ergometer during hemodialysis
Arm Title
B
Arm Type
Active Comparator
Arm Description
Pedometer use outside of hemodialysis
Intervention Type
Behavioral
Intervention Name(s)
ergometer exercise during hemodialysis
Intervention Type
Behavioral
Intervention Name(s)
pedometer activity outside of hemodialysis
Primary Outcome Measure Information:
Title
Aerobic exercise capacity as measured by VO2 peak
Time Frame
3 and 6 months
Title
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 Measure Information:
Title
quality of life measured by SF36
Time Frame
3 and 6 months
Title
dialysis adequacy as measured by ktV
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara J Bohm, MD
Organizational Affiliation
University of Manitoba; Manitoba Renal Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherbrook Dialysis Unit
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1M2
Country
Canada
Facility Name
Central Dialysis Unit, Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada
Facility Name
Seven Oaks General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived

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Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

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