Maintaining Exercise After Cardiac Rehabilitation

September 29, 2005 updated by: The Miriam Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Center for Cardiac Fitness
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Peter Tilkemeier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Participation in exercise (weekly minutes of exercise) at 6 months.

Secondary Outcome Measures

Outcome Measure
Fitness on a sub-maximal graded stress test
Weekly minutes of exercise at 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

April 1, 2007

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Estimate)

October 3, 2005

Last Update Submitted That Met QC Criteria

September 29, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL76734

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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