The Miriam Hospital
Providence, Rhode Island, 02903, United States
NCT Number: NCT02679599
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Time frame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Time frame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation).
Time frame: Baseline through 16 weeks.
Time frame: Change from Baseline to 16 weeks
Time frame: Change from Baseline to 16 weeks
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
The Miriam Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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