Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492362
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2007-06-26
Brief Title:
Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None