Clinical trial NCT05534256: Reducing Sedentary Time in Patients With Cardiovascular Disease
Official title: Reducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Sedentary Behavior
Physical Activity
Keywords: Sedentary behavior
Cardiovascular disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and test a 12-week sedentary behavior reduction intervention ("Sit Less" program) for patients with cardiovascular disease. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help cardiovascular disease patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study whether the program leads to improvements in heart disease risk factors, and whether cardiovascular disease patients like the program and can follow it.

Detailed description: The investigators propose to develop and conduct a pilot 2-arm RCT to test a wearable technology-based sedentary behavior reduction intervention in cardiovascular disease patients. Participants will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in cardiovascular patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Eligibility criteria: Inclusion Criteria:

* Ages 18 and above
* Have at least one of the following conditions including history of heart attack or peripheral artery disease or a stent placed in heart or leg
* Self-report of sitting ≥ 8 hr/day
* Ability to stand and walk
* Ownership of a smartphone

Exclusion Criteria:

* Currently using an activity tracker
* Currently participating in exercise of cardiac rehabilitation programs
* Non-English speaking
* Patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking and
* Currently pregnant

Primary outcomes:
measure: Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview
timeFrame: Baseline to 12 weeks
measure: Level of compliance with the intervention assessed by number of days the Fitbit device was worn
timeFrame: Baseline to 12 weeks
measure: Changes of sedentary behavior assessed by 7 days of activPAL device monitoring
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes of physical activity measured by 7 days of activPAL device monitoring
timeFrame: Baseline and 12 weeks
measure: Changes of cardiometabolic biomarkers measured by blood dried spot card
timeFrame: Baseline and 12 weeks
measure: Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
timeFrame: Baseline and 12 weeks
measure: Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.
timeFrame: Baseline and 12 weeks
measure: Changes of 24-hour glucose levels assessed by continuous glucose monitors
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Chorong Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: