Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Behavioral: Home-based exercise training; Behavioral: Supervised hospital-based exercise training

• Registration Number: NCT01480921
• Lead Sponsor: McMaster University

Brief Summary

The objective of this study is to compare the effect of monitored, home-based exercise versus hospital-based exercise on the quality of life of patients with congestive heart failure. Secondary objectives are to assess the effect of the intervention on exercise capacity and caregiver burden.

The investigators hypothesize that the exercise training in the home-based environment will be superior to hospital based exercise training.

Detailed Description

Congestive heart failure (CHF) is a chronic disease that is associated with enormous burden of illness. Patients with CHF have diminished health-related quality of life, and due to the high demand associated with their everyday activities and self-management, there is consequently a burden upon family caregivers. Though exercise is a component of clinical practice guidelines for the management of CHF, previous studies have not examined the interrelationships among changes in exercise capacity, health-related quality of life (HRQL) and important predictor variables such as self-efficacy, as a result of exercise training in CHF patients. Furthermore, research to date has failed to examine whether a hospital-based or a home-based approach to exercise is the best-suited strategy for long-term adoption and benefit from exercise training. Thus, the most important effective approach to, and environment for, exercise training to improve the health and self-management of CHF patients has not yet been determined. This study will address some important gaps in the existing literature related to the benefits of exercise in CHF, specifically how different exercise approaches and strategies contribute to an individual's HRQL and self-efficacy.

This is a prospective, randomized controlled trial using a two-group, repeated measures design. Male and female patients with New York Heart Association (NYHA) Functional Class I-III CHF will be eligible to participate. Participants will be randomized to receive either supervised, hospital-based exercise or monitored home-based exercise. The participants in the study will train for a period of six months and will be reassessed six months following completion of the intervention to assess sustainability of any observed changes.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-06
• Study Completion: 2007-11
• Status Verified: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• chronic stable heart failure
• NYHA class I, II or III
• willing and able to regularly attend a supervised exercise program
• provision of written, informed consent

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Exclusion Criteria

• unstable angina in the last month
• recent acute MI (last 3 months) which precipitated heart failure
• hospitalized for heart failure in past month
• severe chronic pulmonary disease (FEV1 <40%)
• uncontrolled hypertension (B/P >140/90)
• orthopedic, neurological or psychiatric illness precluding participation in exercise
• heart failure that is amenable to revascularization, which is planned in the near future
• NYHA class IV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home based exercise training	Home-based exercise training	-
supervised exercise training	Supervised hospital-based exercise training	-

Primary Outcome Measures

Name	Time	Method
Change in health-related quality of life (HRQL): Generic and disease specific	baseline, 3 months, 6 months, one year	The Medical Outcomes Short Form-36 will be used to measure generic HRQL.; The Minnesota Living with Heart Failure (MLQHF) Questionnaire will be used to measure disease specific HRQL.

Secondary Outcome Measures

Name	Time	Method
Change in exercise capacity (peak exercise oxygen uptake - VO2)	baseline, 3 months, 6 months, one year	PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
Change in self-efficacy for exercise	baseline, 3 months, 6 months, one year	Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart \& Taylor, 1985)
Change in caregiver burden	baseline, 3 months, 6 months, one year	The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.

Trial Locations

Locations (1)

Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada