Clinical trial NCT01480921: Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure
Official title: The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: heart failure
health related quality of life
exercise capacity
home based exercise training
supervised exercise training
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
name: Hamilton Health Sciences Corporation
First posted: 2011-11-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in health-related quality of life (HRQL): Generic and disease specific
timeFrame: baseline, 3 months, 6 months, one year
Secondary outcomes:
measure: Change in exercise capacity (peak exercise oxygen uptake - VO2)
timeFrame: baseline, 3 months, 6 months, one year
measure: Change in self-efficacy for exercise
timeFrame: baseline, 3 months, 6 months, one year
measure: Change in caregiver burden
timeFrame: baseline, 3 months, 6 months, one year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Heather M Arthur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Robert S McKelvie, MD, PhD
role: STUDY_CHAIR
affiliation: Hamilton Health Scienes
name: Jennifer Kodis, MA
role: STUDY_CHAIR
affiliation: University of Toronto
name: Kevin Thorpe, MSc
role: STUDY_CHAIR
affiliation: Hamilton Health Sciences Corporation
name: Catherine Demers, MD, MSc
role: STUDY_CHAIR
References: