NCT04481490

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

July 20, 2020

Last Update Submit

February 1, 2022

Conditions

Keywords

cardiac rehabilitationphysical activityaccelerometryhome-based

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Baseline, 12-weeks

  • Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.

    Baseline, 4-weeks, 8-weeks, and 12-weeks

Study Arms (2)

Home-based

Cardiac rehabilitation (including exercise training) delivered in a home-based setting, facilitated remotely by Mayo Clinic staff.

Center-based

Cardiac rehabilitation (including exercise training) delivered in a center-based setting, facilitated in person by Mayo Clinic staff.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with qualifying indication for cardiac rehabilitation (e.g. acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, stable angina, heart failure).

You may qualify if:

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

You may not qualify if:

  • Unwilling or unable to participate in cardiac rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Heart DiseasesMyocardial InfarctionHeart Valve DiseasesCoronary Artery DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesBehavior

Study Officials

  • Amanda Bonikowske, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 22, 2020

Study Start

January 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share