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

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Heather Arthur, McMaster University
ClinicalTrials.gov Identifier:
NCT01480921
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Behavioral: Home-based exercise training
Behavioral: Supervised hospital-based exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Change in health-related quality of life (HRQL): Generic and disease specific [ Time Frame: baseline, 3 months, 6 months, one year ] [ Designated as safety issue: No ]

    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:
  • Change in exercise capacity (peak exercise oxygen uptake - VO2) [ Time Frame: baseline, 3 months, 6 months, one year ] [ Designated as safety issue: No ]
    PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.

  • Change in self-efficacy for exercise [ Time Frame: baseline, 3 months, 6 months, one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 3 months, 6 months, one year ] [ Designated as safety issue: No ]
    The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.


Enrollment: 62
Study Start Date: July 2003
Study Completion Date: November 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480921

Locations
Canada, Ontario
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
Hamilton Health Sciences Corporation
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
  More Information

No publications provided

Responsible Party: Heather Arthur, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT01480921     History of Changes
Other Study ID Numbers: NA 5147
Study First Received: November 22, 2011
Last Updated: November 23, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
heart failure
health related quality of life
exercise capacity
home based exercise training
supervised exercise training

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014