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

NCT02679599 | Completed

• 1 other identifier: 215615
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in objectively measured time engaged in sedentary behavior

  Change from Baseline to 12 weeks (i.e., end of rehabilitation)

• Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity

  Change from Baseline to 12 weeks (i.e., end of rehabilitation)

Secondary Outcomes (17)

• Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)

  Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

• Self-reported sedentary behavior (SIT-Q-7d Questionnaire)

  Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

• Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)

  Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

• Self-reported exercise tolerance (Duke activity status index)

  Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

• Health related quality of life (SF-12 Health Survey)

  Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

Study Arms (2)

Cardiac rehabilitation as usual

OTHER

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

Behavioral: Cardiac rehabilitation as usual

Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app

EXPERIMENTAL

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

Other: B-MOBILE-CARDIAC smartphone application; Behavioral: Cardiac rehabilitation as usual

Interventions

B-MOBILE-CARDIAC smartphone application OTHER

Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app

Cardiac rehabilitation as usual BEHAVIORAL

Cardiac rehabilitation as usual; Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• within one week of starting rehabilitation,
• self-report that they can walk for 10 minutes without assistance from others,
• were approved for and are planning to complete 12 weeks of rehabilitation,
• own a compatible Android phone or are willing to be taught to use one by study staff;
• no evidence of cognitive impairment
• able to speak and read English,
• aged 18-75 years,
• no known nickel allergy, and
• willing to follow the protocol (e.g., carry a smartphone for 16 weeks).

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist/Assistant Professor

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 10, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

US (1)