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

NCT ID: NCT01480921

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Keywords

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heart failure health related quality of life exercise capacity home based exercise training supervised exercise training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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home based exercise training

Group Type EXPERIMENTAL

Home-based exercise training

Intervention Type BEHAVIORAL

Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:

* 5-10 min warm-up
* 30 min aerobic interval training (walking or stationary bicycle)
* 10 min cool-down

Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study.

supervised exercise training

Group Type ACTIVE_COMPARATOR

Supervised hospital-based exercise training

Intervention Type BEHAVIORAL

Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:

* 5-10 min of warm-up
* 30 min of aerobic interval training using stationary cycles, treadmills and arm ergometers
* 10 min of cool down

Exercise will be tracked by the participant in exercise log books.

Interventions

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Home-based exercise training

Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:

* 5-10 min warm-up
* 30 min aerobic interval training (walking or stationary bicycle)
* 10 min cool-down

Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study.

Intervention Type BEHAVIORAL

Supervised hospital-based exercise training

Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:

* 5-10 min of warm-up
* 30 min of aerobic interval training using stationary cycles, treadmills and arm ergometers
* 10 min of cool down

Exercise will be tracked by the participant in exercise log books.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Heather Arthur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather M Arthur, PhD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Robert S McKelvie, MD, PhD

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Jennifer Kodis, MA

Role: STUDY_CHAIR

Hamilton Health Scienes

Kevin Thorpe, MSc

Role: STUDY_CHAIR

University of Toronto

Catherine Demers, MD, MSc

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Locations

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Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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NA 5147

Identifier Type: -

Identifier Source: org_study_id