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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679599
• Other study ID #: 215615
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: September 1, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Heart Failure
• Other Cardiac Conditions Among Cardiac Rehabilitation Participants

Intervention

Other:
• B-MOBILE-CARDIAC smartphone application

Behavioral:
• Cardiac rehabilitation as usual

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in objectively measured time engaged in sedentary behavior		Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Primary	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	Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Self-reported sedentary behavior (SIT-Q-7d Questionnaire)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Self-reported exercise tolerance (Duke activity status index)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Health related quality of life (SF-12 Health Survey)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Depressed Mood (Patient Health Questionnaire-9)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Affect (Positive Affect Negative Affect Scales)		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Cognitive status (Montreal Cognitive Assessment score)		Baseline and 12 weeks (i.e., end of rehabilitation).
Secondary	Smartphone application acceptability (study specific scale)		Baseline through 16 weeks.
Secondary	Change in objectively measured time engaged in sedentary behavior		Change from Baseline to 16 weeks
Secondary	Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity		Change from Baseline to 16 weeks
Secondary	Lipid profile		Baseline and 12 weeks (i.e., end of rehabilitation)
Secondary	C-reactive protein		Baseline and 12 weeks (i.e., end of rehabilitation)
Secondary	haemoglobin A1c (HbA1C)		Baseline and 12 weeks (i.e., end of rehabilitation)
Secondary	Blood pressure		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	Waist circumference		Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Secondary	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.