Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic

NCT ID: NCT02679599

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-04-30

Brief Summary

Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not attending rehabilitation and there is a steep drop off in exercise following rehabilitation completion. Moreover, little is known about the amount of time that cardiac rehabilitation patients spend in sedentary behavior, which is associated with increased risk of cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited, enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1) B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants will complete 7 days of objective activity monitoring to measure daily minutes spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At these same time points, participants will complete questionnaires assessing sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning. Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the 4-week follow-up.

Conditions

Acute Coronary Syndrome; Heart Failure; Other Cardiac Conditions Among Cardiac Rehabilitation Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac rehabilitation as usual

Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).

Group Type: OTHER

Cardiac rehabilitation as usual

Intervention Type: BEHAVIORAL

Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app

Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.

Group Type: EXPERIMENTAL

B-MOBILE-CARDIAC smartphone application

Intervention Type: OTHER

Cardiac rehabilitation as usual

Intervention Type: BEHAVIORAL

Interventions

B-MOBILE-CARDIAC smartphone application

Intervention Type: OTHER

Cardiac rehabilitation as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. within one week of starting rehabilitation,

2. self-report that they can walk for 10 minutes without assistance from others,

3. were approved for and are planning to complete 12 weeks of rehabilitation,

4. own a compatible Android phone or are willing to be taught to use one by study staff;

5. no evidence of cognitive impairment

6. able to speak and read English,

7. aged 18-75 years,

8. no known nickel allergy, and

9. willing to follow the protocol (e.g., carry a smartphone for 16 weeks).

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew Busch

Research Scientist/Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

215615

Identifier Type: -

Identifier Source: org_study_id