Home Walking Exercise Training in Advanced Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012883
First received: March 14, 2001
Last updated: February 6, 2014
Last verified: February 2007
  Purpose

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.


Condition Intervention
Heart Failure
Functional Status
Quality of Life
Behavioral: Homewalking exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Walking Exercise Training in Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 110
Study Completion Date: December 2001
Arms Assigned Interventions
Arm 1
Homewalking Exercise Program
Behavioral: Homewalking exercise program

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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012883

Locations
United States, California
VA Greater Los Angeles Health Care System
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Teresita E. Corvera-Tindel, PhD RN MN VA Greater Los Angeles Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012883     History of Changes
Other Study ID Numbers: NRI 96-031
Study First Received: March 14, 2001
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014