Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Behavioral: Home-based exercise training; Behavioral: Supervised 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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: home based exercise training	Behavioral: 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.
Active Comparator: supervised exercise training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life (HRQL): Generic and disease specific	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.	baseline, 3 months, 6 months, one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; Heart and Stroke Foundation of Ontario
• Investigators: Principal Investigator: Heather M Arthur, PhD, Hamilton Health Sciences Corporation; Study Chair: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation; Study Chair: Jennifer Kodis, MA, Hamilton Health Scienes; Study Chair: Kevin Thorpe, MSc, University of Toronto; Study Chair: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 29, 2011
• Last Update Submitted That Met QC Criteria: November 23, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: exercise capacity; heart failure; health related quality of life; home based exercise training; supervised exercise training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NA 5147