Recruiting
Phase 3

Exercise

Sponsor:

The Miriam Hospital

Code:

NCT00230724

Conditions

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Exercise Counseling

Study Details

Brief summary:

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.

Conditions

Cardiovascular Disease

Study ID

NCT00230724

Start date

Apr, 2005

Status verified date

Sep, 2005

Completion date

Apr, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

180 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Educational/Counseling/Training

Interventions and Outcome Measures

Interventions

Exercise Counseling

Primary outcome measure

  • Participation in exercise (weekly minutes of exercise) at 6 months. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Bernardine M Pinto

401-793-8230Bpinto@lifespan.org

Locations

Center for Cardiac Fitness

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Peter Tilkemeier, MD

401-793-4109PTilkemeier@lifespan.org

Loren Stabile

401-793-5811LStabile@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Oct 3, 2005

Last verified

Sep, 2005

Keywords

  • Exercise maintenance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2005-10-03.