Congestive Heart Failure Clinical Trial
Official title:
The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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