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Home Walking Exercise Training in Advanced Heart Failure
This study has been completed.
Study NCT00012883   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: October 31, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

March 14, 2001
October 31, 2008
 
 
 
Complete list of historical versions of study NCT00012883 on ClinicalTrials.gov Archive Site
 
 
 
Home Walking Exercise Training in Advanced Heart Failure
Home Walking Exercise Training in Advanced Heart Failure

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.

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 (78[99%] male; mean age 62.6 � 10.6 years; EF 27 � 8.8%; 63 [80%] NYHA II, 15[20%] NYHA III-IV; HF duration 39.2 � 41.8 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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Heart Failure
  • Functional Status
  • Quality of Life
Behavioral: Homewalking exercise program
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
110
December 2001
 

Inclusion Criteria:

Should have a stable heart failure in the past 3 months (Max Age is 80)

Exclusion Criteria:

Both
18 Years and older
No
 
United States
 
 
NCT00012883
Corvera, Teresita - Principal Investigator, Department of Veterans Affairs
 
Department of Veterans Affairs
 
Principal Investigator: Teresita E. Corvera, RN MN PhD VA Greater Los Angeles Health Care System
Department of Veterans Affairs
July 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.