Cardiovascular DiseasePhase 3NCT00230724
Maintaining Exercise After Cardiac Rehabilitation
A Phase 3 study testing Exercise Counseling in people with Cardiovascular Disease, run by The Miriam Hospital at 1 site in United States.
Trial summary
Maintaining exercise participation among patients who have completed cardiac rehabilitation is integral to secondary prevention of coronary events and cardiac re-hospitalization. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Exercise Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2007
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:: 1) men and women aged >40 years participating in supervised Phase II CR. The CR population tends to be older (mean age: 64.5+11.9, range 38-83 years, Preliminary Studies C.6.) and by including adults as young as 40 years, we expect to offer the program to the majority of Phase II CR patients. (2) scheduled to complete Phase II CR in the next 4 weeks, 3) able to read and speak English, 4) provide consent for medical chart review to extract disease and treatment variables, 5) able to walk unassisted. 6) We plan to include patients who participated in Phase II CR due to a diagnosis of coronary heart disease (e.g., post- MI, CABG, chronic angina pectoris) or chronic heart failure.
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Exclusion Criteria:1) Prior neurological brain disorder (e.g., Seizure Disorder, Traumatic Brain Injury. Patients with prior neurological disease, including large vessel stroke and Alzheimer's Disease will be excluded. 2) An arbitrary Mini-Mental Status Examination (MMSE) cutoff score of >10 will be set to exclude patients whose scores suggest dementia or cognitive impairments that will interfere with ability to provide informed consent and complete research demands.
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Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Cardiac Fitness
Providence, Rhode Island, 02906
Peter Tilkemeier, MD, 401-793-4109, PTilkemeier@lifespan.org
Loren Stabile, 401-793-5811, LStabile@lifespan.org
About this study
Maintaining exercise participation among patients who have completed cardiac rehabilitation is integral to secondary prevention of coronary events and cardiac re-hospitalization. To promote exercise maintenance after completion of a 12 week Phase II rehabilitation program, we propose to offer a theoretically-based intervention that we have used successfully to promote exercise among older, primary-care patients. This program (Maintenance Counseling) includes brief advice from the Cardiac Rehabilitation case manager at Phase II program discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior Change and Social Cognitive Theory. Health educators will provide the telephone-based intervention over 6 months. Using a randomized controlled design, 180 patients will be assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments will include an exercise tolerance test (baseline/post-rehabilitation and 6 months), self-reported exercise participation, motivational readiness for exercise, and objective activity monitoring at baseline, 6, 12 and 18 months.
Read the detailed description
Maintaining exercise participation among patients who have completed cardiac rehabilitation is integral to secondary prevention of coronary events and cardiac re-hospitalization. Patients in Phase II cardiac rehabilitation programs, a majority being older adults, participate in regular supervised exercise during the program; however, long-term adherence to exercise is poor, with only 30% reporting regular exercise at 12 month follow-ups. To promote exercise maintenance after completion of a 12 week Phase II rehabilitation program, we propose to offer a theoretically-based intervention that we have used successfully to promote exercise among older, primary-care patients. This program (Maintenance Counseling) includes brief advice from the Cardiac Rehabilitation case manager at Phase II program discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior Change and Social Cognitive Theory. Health educators will provide the telephone-based intervention over 6 months. Using a randomized controlled design, 180 patients will be assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments will include an exercise tolerance test (baseline/post-rehabilitation and 6 months), self-reported exercise participation, motivational readiness for exercise, and objective activity monitoring at baseline, 6, 12 and 18 months. These data will help to identify whether telephone-based exercise counseling is an effective strategy for sustaining regular exercise and fitness among cardiac rehabilitation patients thereby contributing to secondary prevention of coronary heart disease.
- Conditions
- Cardiovascular Disease
- Being tested
- Exercise Counseling
- Keywords
- Exercise maintenance
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in exercise (weekly minutes of exercise) at 6 months.
Secondary outcomes (2)
Fitness on a sub-maximal graded stress test
Weekly minutes of exercise at 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startApr 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bernardine M Pinto, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230724
- Sponsor's protocol ID
- HL76734
- Status last verified
- Sep 2005
- First submitted
- 29 Sep 2005
- Last updated
- 3 Oct 2005
- Results posted
- No
Publications
Pinto BM, Dunsiger SI. Mediators of exercise maintenance after cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):13-20. doi: 10.1097/HCR.0000000000000065.
PubMed 24983707Pinto BM, Goldstein MG, Papandonatos GD, Farrell N, Tilkemeier P, Marcus BH, Todaro JF. Maintenance of exercise after phase II cardiac rehabilitation: a randomized controlled trial. Am J Prev Med. 2011 Sep;41(3):274-83. doi: 10.1016/j.amepre.2011.04.015.
PubMed 21855741
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Exercise After Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT00230724
- Acronym / sponsor ID
- HL76734
- Conditions
- Cardiovascular Disease
- Keywords
- Exercise maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Apr 2007
- First posted
- 3 Oct 2005 (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.
Maintaining exercise participation among patients who have completed cardiac rehabilitation is integral to secondary prevention of coronary events and cardiac re-hospitalization. To promote exercise maintenance after completion of a 12 week Phase II rehabilitation program, we propose to offer a theoretically-based intervention that we have used successfully to promote exercise among older, primary-care patients. This program (Maintenance Counseling) includes brief advice from the Cardiac Rehabilitation case manager at Phase II program discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior Change and Social Cognitive Theory. Health educators will provide the telephone-based intervention over 6 months. Using a randomized controlled design, 180 patients will be assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments will include an exercise tolerance test (baseline/post-rehabilitation and 6 months), self-reported exercise participation, motivational readiness for exercise, and objective activity monitoring at baseline, 6, 12 and 18 months.
Detailed description
Maintaining exercise participation among patients who have completed cardiac rehabilitation is integral to secondary prevention of coronary events and cardiac re-hospitalization. Patients in Phase II cardiac rehabilitation programs, a majority being older adults, participate in regular supervised exercise during the program; however, long-term adherence to exercise is poor, with only 30% reporting regular exercise at 12 month follow-ups. To promote exercise maintenance after completion of a 12 week Phase II rehabilitation program, we propose to offer a theoretically-based intervention that we have used successfully to promote exercise among older, primary-care patients. This program (Maintenance Counseling) includes brief advice from the Cardiac Rehabilitation case manager at Phase II program discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior Change and Social Cognitive Theory. Health educators will provide the telephone-based intervention over 6 months. Using a randomized controlled design, 180 patients will be assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments will include an exercise tolerance test (baseline/post-rehabilitation and 6 months), self-reported exercise participation, motivational readiness for exercise, and objective activity monitoring at baseline, 6, 12 and 18 months. These data will help to identify whether telephone-based exercise counseling is an effective strategy for sustaining regular exercise and fitness among cardiac rehabilitation patients thereby contributing to secondary prevention of coronary heart disease.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Exercise Counseling | Behavioural | – |
Primary outcome
Participation in exercise (weekly minutes of exercise) at 6 months.
2 secondary outcomes
Fitness on a sub-maximal graded stress test
Weekly minutes of exercise at 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2005.
- Derived from this study: PubMed 24983707Pinto BM, Dunsiger SI. Mediators of exercise maintenance after cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):13-20. doi: 10.1097/HCR.0000000000000065.
- Derived from this study: PubMed 21855741Pinto BM, Goldstein MG, Papandonatos GD, Farrell N, Tilkemeier P, Marcus BH, Todaro JF. Maintenance of exercise after phase II cardiac rehabilitation: a randomized controlled trial. Am J Prev Med. 2011 Sep;41(3):274-83. doi: 10.1016/j.amepre.2011.04.015.
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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.
Bernardine M Pinto, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise Counseling in people with Cardiovascular Disease, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 3 Oct 2005. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernardine M Pinto (401-793-8230, Bpinto@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in exercise (weekly minutes of exercise) at 6 months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230724, which also lists 2 linked publications.
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 3 Oct 2005.