Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047437
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2002-10-03
Brief Title:
Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Heart Failure A Controlled Trial Investigating Outcomes of Exercise Training HF-ACTION
Status:
COMPLETED
Status Verified Date:
2013-03
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 purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure CHF
Detailed Description:
BACKGROUND
CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65 Although exercise training improves several clinical measures in individuals with CHF eg peak VO2 heart rate variability and plasma norepinephrine levels it is not known whether exercise training reduces mortality in individuals with CHF
DESIGN NARRATIVE
This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning is economically advantageous and prevents medical complications
Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education or standard medical therapy and education plus a supervised exercise training program The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle which will be provided for them
Recruitment Status As of November 9 2006 HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February 2007 with an anticipated enrollment of approximately 2300 subjects
CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65 Although exercise training improves several clinical measures in individuals with CHF eg peak VO2 heart rate variability and plasma norepinephrine levels it is not known whether exercise training reduces mortality in individuals with CHF
DESIGN NARRATIVE
This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning is economically advantageous and prevents medical complications
Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education or standard medical therapy and education plus a supervised exercise training program The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle which will be provided for them
Recruitment Status As of November 9 2006 HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February 2007 with an anticipated enrollment of approximately 2300 subjects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL063747 | NIH | None | None |
| U01HL064250 | NIH | None | None |
| U01HL064257 | NIH | None | None |
| U01HL064264 | NIH | None | None |
| U01HL064265 | NIH | None | None |
| U01HL066461 | NIH | None | None |
| U01HL066482 | NIH | None | None |
| U01HL066491 | NIH | None | None |
| U01HL066494 | NIH | None | None |
| U01HL066497 | NIH | None | None |
| U01HL066501 | NIH | None | None |
| U01HL068973 | NIH | None | None |
| U01HL068980 | NIH | None | httpsreporternihgovquickSearchU01HL068980 |