Clinical trial NCT02679599: Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Heart Failure
Other Cardiac Conditions Among Cardiac Rehabilitation Participants
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: Change in objectively measured time engaged in sedentary behavior
timeFrame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
measure: Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
timeFrame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Secondary outcomes:
measure: Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Self-reported exercise tolerance (Duke activity status index)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Health related quality of life (SF-12 Health Survey)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Depressed Mood (Patient Health Questionnaire-9)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Affect (Positive Affect Negative Affect Scales)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Cognitive status (Montreal Cognitive Assessment score)
timeFrame: Baseline and 12 weeks (i.e., end of rehabilitation).
measure: Smartphone application acceptability (study specific scale)
timeFrame: Baseline through 16 weeks.
measure: Change in objectively measured time engaged in sedentary behavior
timeFrame: Change from Baseline to 16 weeks
measure: Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
timeFrame: Change from Baseline to 16 weeks
measure: Lipid profile
timeFrame: Baseline and 12 weeks (i.e., end of rehabilitation)
measure: C-reactive protein
timeFrame: Baseline and 12 weeks (i.e., end of rehabilitation)
measure: haemoglobin A1c (HbA1C)
timeFrame: Baseline and 12 weeks (i.e., end of rehabilitation)
measure: Blood pressure
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Waist circumference
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
measure: Body Mass Index (kg/m^2, weight in kilograms, height in meters)
timeFrame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References: