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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home-based exercise training
Supervised hospital-based exercise training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring heart failure, health related quality of life, exercise capacity, home based exercise training, supervised exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

home based exercise training

supervised exercise training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in exercise capacity (peak exercise oxygen uptake - VO2)
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
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)
Change in caregiver burden
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.

Full Information

First Posted
November 22, 2011
Last Updated
November 23, 2011
Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01480921
Brief Title
Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure
Acronym
PEAK-HF
Official Title
The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
heart failure, health related quality of life, exercise capacity, home based exercise training, supervised exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home based exercise training
Arm Type
Experimental
Arm Title
supervised exercise training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Home-based exercise training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supervised hospital-based exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health-related quality of life (HRQL): Generic and disease specific
Description
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.
Time Frame
baseline, 3 months, 6 months, one year
Secondary Outcome Measure Information:
Title
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Description
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
Time Frame
baseline, 3 months, 6 months, one year
Title
Change in self-efficacy for exercise
Description
Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart & Taylor, 1985)
Time Frame
baseline, 3 months, 6 months, one year
Title
Change in caregiver burden
Description
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
Time Frame
baseline, 3 months, 6 months, one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather M Arthur, PhD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert S McKelvie, MD, PhD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jennifer Kodis, MA
Organizational Affiliation
Hamilton Health Scienes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kevin Thorpe, MSc
Organizational Affiliation
University of Toronto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Catherine Demers, MD, MSc
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

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Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure

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