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Clinical Trials/NCT04481490
NCT04481490WithdrawnNot Applicable

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

Mayo Clinic0 sitesStarted: January 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry

Time Frame: 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 Outcomes

  • Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.(Baseline, 4-weeks, 8-weeks, and 12-weeks)
  • Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire(Baseline, 12-weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amanda R. Bonikowske

Principal Investigator

Mayo Clinic

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