Wearables and Cardiac Rehabilitation

NCT ID: NCT06065319

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

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The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring recovering of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

Detailed Description

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The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring the recovery of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

This work will use data from cardiac rehabilitation, captured from smartwatches, and data from rest/sleep, captured from smartwatches and smartrings, to see if there are trends in recovery that can be modeled. Recovery is measured as an improvement in 6 minute walk test performance over the course of cardiac rehabilitation.

Conditions

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Cardiac Rehabilitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Comers to Cardiac Rehabilitation

Any participant that is enrolled in cardiac rehabilitation is eligible for this study.

Wearable Sensors

Intervention Type DEVICE

Participants will wear smartwatches and smartrings and this data will be used to design algorithms which seek to find associations between device data and recovery.

Interventions

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Wearable Sensors

Participants will wear smartwatches and smartrings and this data will be used to design algorithms which seek to find associations between device data and recovery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
* Age 18 or older
* Native English speaker

Exclusion Criteria

* Inability to wear one or more SmartWatches or Smartring
* Inability to walk unassisted
* Inability to participate in cardiac rehabilitation
* Inability to use a smartphone to aid in upload of remote data
* Lack of smartphone to use in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascension Health

INDUSTRY

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kurian

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

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Ascension Health

Austin, Texas, United States

Site Status

Texas A&M University

College Station, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21EB028486

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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