Clinical trial NCT00230724: Maintaining Exercise After Cardiac Rehabilitation
Official title: Maintaining Exercise After Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiovascular Disease
Keywords: Exercise maintenance
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2005-10-03
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Participation in exercise (weekly minutes of exercise) at 6 months.
Secondary outcomes:
measure: Fitness on a sub-maximal graded stress test
measure: Weekly minutes of exercise at 12 and 18 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Cardiac Fitness
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Bernardine M Pinto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pinto 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.