Cardiac Rehabilitation and Sedentary Behavior

NCT ID: NCT03200756

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2017-06-20

Brief Summary

This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.

Detailed Description

Cardiac rehabilitation after a cardiac event or procedure is of key importance to physical and psychological recovery. Cardiac rehabilitation comprises a standardized stepwise approach to exercise in a supervised setting and is proven to reduce morbidity and mortality after a cardiac event. However, cardiac rehabilitation does not necessarily change behavior in the long-term and many do not attend cardiac rehabilitation due to lack of motivation, difficulty accessing programs, and cost. These individuals loose an important opportunity to improve their health, sense of well-being and outcomes. The investigators propose to test the effect of a patient-centered approach to reduce sedentary behavior for aging adults added to usual cardiac rehabilitation. In this study, the investigators will identify patients at their introductory visit to cardiac rehabilitation and randomize to either a program to decrease in-home sedentary behavior vs. a standard program to increase in-home exercise. Both groups will receive additional support and encouragement to attend cardiac rehabilitation. Using motivational interviewing techniques in both groups the investigators will assist the patients in recognizing their potential and goal-setting. Patients will be monitored using the ActivPAL monitor, a new technology that quantifies sedentary time and steps/day. Patients will be monitored four times as they proceed through cardiac rehabilitation for a total of 13 weeks and receive 3 educational and goal setting sessions. Those in the intervention group will have sedentary behavior change emphasized with feedback from the ActivPAL monitor. The control group will focus on standard exercise recommendations and feedback from his/her exercise diary. Outcomes include change in sedentary time and steps/day. Anticipated results include a significant change in the intervention group vs. the control: a decrease in in-home sedentary time, an increase in steps/day. The results of this study will provide the basis for designing a larger randomized controlled trial to investigate the effects of an intervention to reduce sedentary behavior as an adjunct to cardiac rehabilitation especially for older adults. Additional investigation will be warranted for those who do not attend cardiac rehabilitation but are able to follow a post-cardiac event program to reduce in-home sedentary behavior.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sedentary Group

The experimental group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

Group Type: EXPERIMENTAL

Sedentary Group

Intervention Type: BEHAVIORAL

The sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

Exercise Group

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

Group Type: ACTIVE_COMPARATOR

Exercise Group

Intervention Type: BEHAVIORAL

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

Interventions

Sedentary Group

The sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

Intervention Type: BEHAVIORAL

Exercise Group

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients enrolled in Cardiac Rehabilitation
• Age 50 years old or greater
• Short Physical Performance Battery (SPPB) score equal or less than 10

Exclusion Criteria

• Hypoxia
• Orthopedic Disease that limits mobility
• Neurologic Disease that limits mobility
• Metastatic Cancer
• Life expectancy of <6 months
• Depression
• Montreal Cognitive Assessment less than 24
• Left Ventricular Assist Device (LVAD)
• Cardiac Transplant
• Patient Health Questionnaire-9 (PHQ-9) of 15 or greater

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boxer Rebecca, MD,MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital Cardiovascular Rehabilitation

Aurora, Colorado, United States

Countries

United States

Other Identifiers

15-1914

Identifier Type: -

Identifier Source: org_study_id