NCT00230724

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 3, 2005

Status Verified

September 1, 2005

First QC Date

September 29, 2005

Last Update Submit

September 29, 2005

Conditions

Cardiovascular Disease

Keywords

Exercise maintenance

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Exercise CounselingBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cardiac Fitness

Providence, Rhode Island, 02906, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 24983707DERIVED

  • 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.

    PMID: 21855741DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Bernardine M Pinto, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernardine M Pinto

CONTACT

401-793-8230Bpinto@lifespan.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

October 3, 2005

Record last verified: 2005-09

Locations

US(1)