Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108147
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2005-04-14
Brief Title:
Functional Circuit Training in Older Adults With Congestive Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Functional Circuit Training in Older Adults With Congestive Heart Failure
Status:
COMPLETED
Status Verified Date:
2009-03
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:
The goal of this study is to determine the effect of a functional circuit training program as compared to standard cardiac rehabilitation or control exercise in improving physical function and activity
Detailed Description:
In older 65 years of age or older patients with congestive heart failure we propose to
1 Assess a Peak aerobic capacity peak VO2 during a monitored standardized treadmill test b Oxygen uptake kinetics and heart rate during a standardized submaximal treadmill test c Performance on a set of functional mobility tasks d Self-report of physical disability and difficulty in performing daily tasks and physical activity
2 Conduct a 12-week randomized controlled trial comparing changes in these assessed measures in patients randomized to three different groups 1 standard cardiac rehabilitation using bicycle exercise 2 group functional circuit training focusing on exercises that involve functional mobility tasks and a home-activities exercise component 3 a chair-based flexibility and toning low level resistance group control exercise
3 Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function
4 Examine the mechanisms underlying change in functional mobility performance and self-reported function as a result of the interventions
Primary hypothesis 1 Compared to chair-based exercise controls at the end of week 12 both the cardiac rehabilitation and functional circuit training groups will show improvements in measures of peak aerobic capacity submaximal oxygen uptake kinetics functional mobility performance and self-reported function
Primary hypothesis 2 Compared to the other two groups that are given exercise instructions only the functional circuit training group who continue their home activities exercise program show less decline by week 24 in measures of peak aerobic capacity submaximal oxygen uptake kinetics functional mobility performance and self-reported function
Secondary hypothesis Measures of submaximal oxygen uptake kinetics are better predictors of changes in functional mobility performance and self-reported function than peak aerobic capacity muscle strength joint range of motion balance and behavioral factors such as depression
1 Assess a Peak aerobic capacity peak VO2 during a monitored standardized treadmill test b Oxygen uptake kinetics and heart rate during a standardized submaximal treadmill test c Performance on a set of functional mobility tasks d Self-report of physical disability and difficulty in performing daily tasks and physical activity
2 Conduct a 12-week randomized controlled trial comparing changes in these assessed measures in patients randomized to three different groups 1 standard cardiac rehabilitation using bicycle exercise 2 group functional circuit training focusing on exercises that involve functional mobility tasks and a home-activities exercise component 3 a chair-based flexibility and toning low level resistance group control exercise
3 Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function
4 Examine the mechanisms underlying change in functional mobility performance and self-reported function as a result of the interventions
Primary hypothesis 1 Compared to chair-based exercise controls at the end of week 12 both the cardiac rehabilitation and functional circuit training groups will show improvements in measures of peak aerobic capacity submaximal oxygen uptake kinetics functional mobility performance and self-reported function
Primary hypothesis 2 Compared to the other two groups that are given exercise instructions only the functional circuit training group who continue their home activities exercise program show less decline by week 24 in measures of peak aerobic capacity submaximal oxygen uptake kinetics functional mobility performance and self-reported function
Secondary hypothesis Measures of submaximal oxygen uptake kinetics are better predictors of changes in functional mobility performance and self-reported function than peak aerobic capacity muscle strength joint range of motion balance and behavioral factors such as depression
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