A Study to Objectively Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation

Withdrawn

• Conditions: Cardiac Disease; Myocardial Infarction; Cardiac Valve Disease; Coronary Artery Disease

• Registration Number: NCT04481490
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation.

Detailed Description

Participants enrolled in either home-based or center-based cardiac rehabilitation will be instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and 12-weeks, to objectively measure their physical activity level during the cardiac rehabilitation program. A questionnaire will also be completed by the participant at baseline and 12-weeks to subjectively measure their physical activity level, based on self-report activities over the previous 7-days.

Enrollment in home-based versus center-based cardiac rehabilitation will be based on the availability of cardiac rehabilitation facilities and/or patient preference. There is no random allocation or assignment to groups by the study team.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2022-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-11
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult 18 years and older.
• Able to provide consent.
• Has a qualifying indication for cardiac rehabilitation and able to participate in cardiac rehabilitation.

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Exclusion Criteria

• Unwilling or unable to participate in cardiac rehabilitation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry	Baseline, 4-weeks, 8-weeks, and 12-weeks	Change in minutes at a moderate-vigorous activity intensity are objectively measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends in moderate-vigorous activities per day, and will be worn by the participant for 7-days. A higher number of minutes per day indicates a greater physical activity level.

Secondary Outcome Measures

Name	Time	Method
Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.	Baseline, 4-weeks, 8-weeks, and 12-weeks	Change in minutes spent in inactive (sedentary) behavior, measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends inactive per day, and will be worn by the participant for 7-days. A higher number of minutes per day of inactive time indicates increased sedentary behavior.
Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire	Baseline, 12-weeks	Change in minutes at a moderate-vigorous activity intensity are subjectively measured (self-reported) using the International Physical Activity Questionnaire (IPAQ). The IPAQ captures the number of minutes a participant spends in moderate-vigorous activities per day, based on participant's reporting of the previous 7-days. A higher number of minutes per day indicates a greater physical activity level.