Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
Primary Purpose
Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B-MOBILE-CARDIAC smartphone application
Cardiac rehabilitation as usual
Sponsored by

About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
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:
-
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Cardiac rehabilitation as usual
Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Arm Description
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.
Outcomes
Primary Outcome Measures
Change in objectively measured time engaged in sedentary behavior
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Secondary Outcome Measures
Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Self-reported exercise tolerance (Duke activity status index)
Health related quality of life (SF-12 Health Survey)
Depressed Mood (Patient Health Questionnaire-9)
Affect (Positive Affect Negative Affect Scales)
Cognitive status (Montreal Cognitive Assessment score)
Smartphone application acceptability (study specific scale)
Change in objectively measured time engaged in sedentary behavior
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Lipid profile
C-reactive protein
haemoglobin A1c (HbA1C)
Blood pressure
Waist circumference
Body Mass Index (kg/m^2, weight in kilograms, height in meters)
Full Information
NCT ID
NCT02679599
First Posted
February 2, 2016
Last Updated
September 1, 2017
Sponsor
The Miriam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02679599
Brief Title
Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac rehabilitation as usual
Arm Type
Other
Arm Description
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
Arm Title
Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Arm Type
Experimental
Arm Description
Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.
Intervention Type
Other
Intervention Name(s)
B-MOBILE-CARDIAC smartphone application
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation as usual
Primary Outcome Measure Information:
Title
Change in objectively measured time engaged in sedentary behavior
Time Frame
Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Title
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 Outcome Measure Information:
Title
Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Self-reported exercise tolerance (Duke activity status index)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Health related quality of life (SF-12 Health Survey)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Depressed Mood (Patient Health Questionnaire-9)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Affect (Positive Affect Negative Affect Scales)
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Cognitive status (Montreal Cognitive Assessment score)
Time Frame
Baseline and 12 weeks (i.e., end of rehabilitation).
Title
Smartphone application acceptability (study specific scale)
Time Frame
Baseline through 16 weeks.
Title
Change in objectively measured time engaged in sedentary behavior
Time Frame
Change from Baseline to 16 weeks
Title
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Time Frame
Change from Baseline to 16 weeks
Title
Lipid profile
Time Frame
Baseline and 12 weeks (i.e., end of rehabilitation)
Title
C-reactive protein
Time Frame
Baseline and 12 weeks (i.e., end of rehabilitation)
Title
haemoglobin A1c (HbA1C)
Time Frame
Baseline and 12 weeks (i.e., end of rehabilitation)
Title
Blood pressure
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
Waist circumference
Time Frame
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
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