Maintaining Exercise After Cardiac Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by The Miriam Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00230724
First received: September 29, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Behavioral: Exercise Counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Maintaining Exercise After Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Participation in exercise (weekly minutes of exercise) at 6 months.

Secondary Outcome Measures:
  • Fitness on a sub-maximal graded stress test
  • Weekly minutes of exercise at 12 and 18 months

Estimated Enrollment: 180
Study Start Date: April 2005
Estimated Study Completion Date: April 2007
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230724

Contacts
Contact: Bernardine M Pinto 401-793-8230 Bpinto@lifespan.org

Locations
United States, Rhode Island
Center for Cardiac Fitness Recruiting
Providence, Rhode Island, United States, 02906
Contact: Peter Tilkemeier, MD    401-793-4109    PTilkemeier@lifespan.org   
Contact: Loren Stabile    401-793-5811    LStabile@lifespan.org   
Sub-Investigator: Peter Tilkemeier, MD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Bernardine M Pinto, Ph.D. The Miriam Hospital
  More Information

No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00230724     History of Changes
Other Study ID Numbers: HL76734
Study First Received: September 29, 2005
Last Updated: September 29, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Exercise maintenance

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014