Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012883
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Home Walking Exercise Training in Advanced Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Home Walking Exercise Training in Advanced 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:
Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality and reduce exercise capacity with distressing symptoms of dyspnea and fatigue Evaluating the effects of complementary intervention such as exercise training on functional status and QOL are clinically important and relevant to HF patients
In the last decade hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption VO2 and symptom scores and restore autonomic balance These programs may be costly for patients to perform Improved peak VO2 may not necessarily translate into improved functional status and quality of life To date the effects of a home walking exercise program alone on functional status QOL and autonomic tone has not been evaluated
In the last decade hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption VO2 and symptom scores and restore autonomic balance These programs may be costly for patients to perform Improved peak VO2 may not necessarily translate into improved functional status and quality of life To date the effects of a home walking exercise program alone on functional status QOL and autonomic tone has not been evaluated
Detailed Description:
Background
Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality and reduce exercise capacity with distressing symptoms of dyspnea and fatigue Evaluating the effects of complementary intervention such as exercise training on functional status and QOL are clinically important and relevant to HF patients
In the last decade hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption VO2 and symptom scores and restore autonomic balance These programs may be costly for patients to perform Improved peak VO2 may not necessarily translate into improved functional status and quality of life To date the effects of a home walking exercise program alone on functional status QOL and autonomic tone has not been evaluated
Objectives
The specific aim was to compare functional status FS quality of life QOL and autonomic tone in 2 groups of advanced HF patients nurse-managed home walking exercise HWE group vs control group
Methods
A randomized controlled trial comparing a 12-week nurse-managed progressive HWE protocol to usual activity was conducted in 79 HF patients 7899 male mean age 626 106 years EF 27 88 63 80 NYHA II 1520 NYHA III-IV HF duration 392 418 months from a VA medical center and a university affiliated medical center The 12- week HWE program is once a day 5x a week and initiated at 10 minutes and progressively increases in duration and intensity up to 60 minutes Pre- and post-study measures were FS peak VO2 and ventilatory threshold via CPX 6-minute walk test 6MWT and a Heart Failure Functional Status Inventory HFFSI QOL Cardiac Quality of life Index C-QLI SF-36 and Dyspnea-Fatigue Index DFI with global rating of symptoms and autonomic tone norepinephrine NE and heart rate variability HRV Intention-to-treat analysis with repeated measures ANOVA was used to identify group differences
Status
Completed
Heart failure is a major public health burden in the United States characterized by increased morbidity and mortality and reduce exercise capacity with distressing symptoms of dyspnea and fatigue Evaluating the effects of complementary intervention such as exercise training on functional status and QOL are clinically important and relevant to HF patients
In the last decade hospital-based and a home bicycle exercise programs for HF have been shown to improve peak oxygen consumption VO2 and symptom scores and restore autonomic balance These programs may be costly for patients to perform Improved peak VO2 may not necessarily translate into improved functional status and quality of life To date the effects of a home walking exercise program alone on functional status QOL and autonomic tone has not been evaluated
Objectives
The specific aim was to compare functional status FS quality of life QOL and autonomic tone in 2 groups of advanced HF patients nurse-managed home walking exercise HWE group vs control group
Methods
A randomized controlled trial comparing a 12-week nurse-managed progressive HWE protocol to usual activity was conducted in 79 HF patients 7899 male mean age 626 106 years EF 27 88 63 80 NYHA II 1520 NYHA III-IV HF duration 392 418 months from a VA medical center and a university affiliated medical center The 12- week HWE program is once a day 5x a week and initiated at 10 minutes and progressively increases in duration and intensity up to 60 minutes Pre- and post-study measures were FS peak VO2 and ventilatory threshold via CPX 6-minute walk test 6MWT and a Heart Failure Functional Status Inventory HFFSI QOL Cardiac Quality of life Index C-QLI SF-36 and Dyspnea-Fatigue Index DFI with global rating of symptoms and autonomic tone norepinephrine NE and heart rate variability HRV Intention-to-treat analysis with repeated measures ANOVA was used to identify group differences
Status
Completed
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