Completed

Reducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Sit Less Program

Behavioral
Who is being recruted

Behavior+2

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 13, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleReducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial
NCT05534256
Principal SponsorVanderbilt University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorCardiovascular DiseasesHeart DiseasesMotor ActivitySedentary Behavior

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Vanderbilt University

Nashville, United StatesOpen Vanderbilt University in Google Maps
CompletedOne Study Center