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

November 22, 2011
November 23, 2011
July 2003
June 2006   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01480921 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Congestive Heart Failure
  • 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.

  • 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.

  • Experimental: home based exercise training
    Intervention: Behavioral: Home-based exercise training
  • Active Comparator: supervised exercise training
    Intervention: Behavioral: Supervised hospital-based exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
November 2007
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01480921
NA 5147
No
Heather Arthur, McMaster University
McMaster University
  • Heart and Stroke Foundation of Ontario
  • Hamilton Health Sciences Corporation
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
McMaster University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP