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
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedNovember 29, 2011
November 1, 2011
2.9 years
November 22, 2011
November 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in exercise capacity (peak exercise oxygen uptake - VO2)
baseline, 3 months, 6 months, one year
Change in self-efficacy for exercise
baseline, 3 months, 6 months, one year
Change in caregiver burden
baseline, 3 months, 6 months, one year
Study Arms (2)
home based exercise training
EXPERIMENTALsupervised exercise training
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Heart and Stroke Foundation of Ontariocollaborator
- Hamilton Health Sciences Corporationcollaborator
Study Sites (1)
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 29, 2011
Study Start
July 1, 2003
Primary Completion
June 1, 2006
Study Completion
November 1, 2007
Last Updated
November 29, 2011
Record last verified: 2011-11