Home Walking Exercise Training in Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

Home Walking Exercise Training in Advanced Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012883
• Other study ID #: NRI 96-031
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: December 2001

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Status
• Heart Failure
• Quality of Life

Intervention

Behavioral:
• Homewalking exercise program

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,