Clinical trial NCT00492362: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: hemodialysis
exercise
physical fitness
dialysis adequacy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Aerobic exercise capacity as measured by VO2 peak
timeFrame: 3 and 6 months
measure: physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test
timeFrame: 3 and 6 months
Secondary outcomes:
measure: quality of life measured by SF36
timeFrame: 3 and 6 months
measure: dialysis adequacy as measured by ktV
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Sherbrook Dialysis Unit
state: Manitoba
city: Winnipeg
country: Canada
facility: Central Dialysis Unit, Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba; Manitoba Renal Program
name: Clara J Bohm, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.