Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013221
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Chronic heart failure HF is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue dyspnea and decreased exercise capacity These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function Until recently the prescription for individuals with HF was rest and minimization of physical exertion
Detailed Description:
Background
Chronic heart failure HF is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue dyspnea and decreased exercise capacity These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function Until recently the prescription for individuals with HF was rest and minimization of physical exertion
Objectives
The primary objectives of this randomized clinical trial were to determine whether subjects with moderate to severe chronic HF who completed a 12-week individualized program of cardiopulmonary training exercise group would have significantly greater i quality of life measured by the Rand Short Form-36 and ii aerobic fitness measured by oxygen uptake during symptom limited maximal metabolic treadmill testing than subjects who met weekly with an investigator and received vital sign measurements non-exercise group
Methods
A randomized controlled clinical trial was utilized Individuals who met the inclusion criteria were randomly assigned to either an exercise or control group Individuals in the exercise group received 36 weeks of exercise training primary outcome variables were measured at 12 weeks Participants in the control group received weekly visits with a nurse for 12 weeks
Status
Ongoing data analysis for publication Final report submitted
Chronic heart failure HF is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue dyspnea and decreased exercise capacity These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function Until recently the prescription for individuals with HF was rest and minimization of physical exertion
Objectives
The primary objectives of this randomized clinical trial were to determine whether subjects with moderate to severe chronic HF who completed a 12-week individualized program of cardiopulmonary training exercise group would have significantly greater i quality of life measured by the Rand Short Form-36 and ii aerobic fitness measured by oxygen uptake during symptom limited maximal metabolic treadmill testing than subjects who met weekly with an investigator and received vital sign measurements non-exercise group
Methods
A randomized controlled clinical trial was utilized Individuals who met the inclusion criteria were randomly assigned to either an exercise or control group Individuals in the exercise group received 36 weeks of exercise training primary outcome variables were measured at 12 weeks Participants in the control group received weekly visits with a nurse for 12 weeks
Status
Ongoing data analysis for publication Final report submitted
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