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

Coronary Artery Disease Clinical Trial

Official title:

Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04481490
• Other study ID #: 20-005866
• Status: Withdrawn
• Start date: January 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Unwilling or unable to participate in cardiac rehabilitation.

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Valve Disease
• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry	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.	Baseline, 4-weeks, 8-weeks, and 12-weeks
Secondary	Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire	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.	Baseline, 12-weeks
Secondary	Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.	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.	Baseline, 4-weeks, 8-weeks, and 12-weeks

External Links

•   Mayo Clinic Clinical Trials