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

The Miriam Hospital23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

Change in objectively measured time engaged in sedentary behavior

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

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

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

Secondary Outcomes

Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)

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

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

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

Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)

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

Self-reported exercise tolerance (Duke activity status index)

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

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

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

Depressed Mood (Patient Health Questionnaire-9)

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

Affect (Positive Affect Negative Affect Scales)

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

Cognitive status (Montreal Cognitive Assessment score)

Time frame: Baseline and 12 weeks (i.e., end of rehabilitation).

Smartphone application acceptability (study specific scale)

Time frame: Baseline through 16 weeks.

Change in objectively measured time engaged in sedentary behavior

Time frame: Change from Baseline to 16 weeks

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

Time frame: Change from Baseline to 16 weeks

Lipid profile

Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)

C-reactive protein

Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)

haemoglobin A1c (HbA1C)

Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)

Blood pressure

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

Waist circumference

Time frame: 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)

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes