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

Study Overview
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Brief Summary
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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
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Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants

Intervention / Treatment
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* Other: B-MOBILE-CARDIAC smartphone application
* Behavioral: Cardiac rehabilitation as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac rehabilitation as usual<br>Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting). | Behavioral: Cardiac rehabilitation as usual<br> <br> |
| Experimental: Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app<br>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<br> <br> Behavioral: Cardiac rehabilitation as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Depressed Mood (Patient Health Questionnaire-9) |  | Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks. | 
| Affect (Positive Affect Negative Affect Scales) |  | Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks. | 
| Cognitive status (Montreal Cognitive Assessment score) |  | Baseline and 12 weeks (i.e., end of rehabilitation). | 
| Smartphone application acceptability (study specific scale) |  | Baseline through 16 weeks. | 
| Change in objectively measured time engaged in sedentary behavior |  | Change from Baseline to 16 weeks | 
| Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity |  | Change from Baseline to 16 weeks | 
| Lipid profile |  | Baseline and 12 weeks (i.e., end of rehabilitation) | 
| C-reactive protein |  | Baseline and 12 weeks (i.e., end of rehabilitation) | 
| haemoglobin A1c (HbA1C) |  | Baseline and 12 weeks (i.e., end of rehabilitation) | 
| Blood pressure |  | Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks. | 
| Waist circumference |  | Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks. | 
| Body Mass Index (kg/m^2, weight in kilograms, height in meters) |  | Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks. |