Congestive Heart FailurePEAK-HFNCT01480921
Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure
A study testing Home-based exercise training and Supervised hospital-based exercise training in people with Congestive Heart Failure, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Home-based exercise training and Supervised hospital-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- Home-based exercise training, Supervised hospital-based exercise training
- Keywords
- heart failure, health related quality of life, exercise capacity, home based exercise training, supervised exercise training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise trainingBehavioural
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.
Supervised hospital-based exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| home based exercise training | Experimental | Not described Receives: Behavioral: Home-based exercise training |
| supervised exercise training | Active comparator | Not described Receives: Behavioral: Supervised hospital-based exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months, 6 months, one year
Secondary outcomes (3)
Change in exercise capacity (peak exercise oxygen uptake - VO2)
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
Measured: baseline, 3 months, 6 months, one year
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)
Measured: baseline, 3 months, 6 months, one year
Change in caregiver burden
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
Measured: baseline, 3 months, 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJul 2003
- Primary completionJun 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Heather Arthur, McMaster University
- Investigators
- Heather M Arthur, PhD, Principal investigator, Hamilton Health Sciences CorporationRobert S McKelvie, MD, PhD, Study chair, Hamilton Health Sciences CorporationJennifer Kodis, MA, Study chair, Hamilton Health ScienesKevin Thorpe, MSc, Study chair, University of TorontoCatherine Demers, MD, MSc, Study chair, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480921
- Sponsor's protocol ID
- NA 5147
- Acronym
- PEAK-HF
- Status last verified
- Nov 2011
- First submitted
- 22 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure
- ClinicalTrials.gov ID
- NCT01480921
- Acronym / sponsor ID
- PEAK-HF / NA 5147
- Conditions
- Congestive Heart Failure
- Keywords
- heart failure, health related quality of life, exercise capacity, home based exercise training, supervised exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation
- Study start
- Jul 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home based exercise training | Experimental | Behavioral: Home-based exercise training |
| supervised exercise training | Active comparator | Behavioral: Supervised hospital-based exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise trainingParticipants 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. | Behavioural | home based exercise training |
| Supervised hospital-based exercise trainingPatients 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. | Behavioural | supervised exercise training |
Primary outcome
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.
3 secondary outcomes
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Time frame: baseline, 3 months, 6 months, one year
Change in self-efficacy for exercise
Time frame: baseline, 3 months, 6 months, one year
Change in caregiver burden
Time frame: baseline, 3 months, 6 months, one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather M Arthur, PhD principal investigator
Hamilton Health Sciences Corporation
Robert S McKelvie, MD, PhD study chair
Hamilton Health Sciences Corporation
Jennifer Kodis, MA study chair
Hamilton Health Scienes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise training and Supervised hospital-based exercise training in people with Congestive Heart Failure, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (HRQL): Generic and disease specific (time frame: baseline, 3 months, 6 months, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.