Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)
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|ClinicalTrials.gov Identifier: NCT01480921|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 29, 2011
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 or disease||Intervention/treatment|
|Congestive Heart Failure||Behavioral: Home-based exercise training Behavioral: Supervised 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure|
|Study Start Date :||July 2003|
|Primary Completion Date :||June 2006|
|Study Completion Date :||November 2007|
|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:
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:
Exercise will be tracked by the participant in exercise log books.
- Change in health-related quality of life (HRQL): Generic and disease specific [ Time Frame: baseline, 3 months, 6 months, one year ]
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.
- Change in exercise capacity (peak exercise oxygen uptake - VO2) [ Time Frame: baseline, 3 months, 6 months, one year ]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 ]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 ]The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480921
|Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|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|