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

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 Overview

• Status: Completed
• Conditions: Heart Failure; Acute Coronary Syndrome; Other Cardiac Conditions Among Cardiac Rehabilitation Participants
• Intervention / Treatment: Behavioral: Cardiac rehabilitation as usual; Other: B-MOBILE-CARDIAC smartphone application

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardiac rehabilitation as usual; Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).	Behavioral: Cardiac rehabilitation as usual
Experimental: Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app; Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.	Behavioral: Cardiac rehabilitation as usual; Other: B-MOBILE-CARDIAC smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in objectively measured time engaged in sedentary behavior	Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 215615