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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06065319
Other study ID # R21EB028486
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date May 31, 2024

Study information

Verified date August 2023
Source Texas A&M University
Contact Chloe Cowan
Phone 51232443434
Email chloe.cowan@ascension.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 31, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - There is a change in participant health such that the participant meets any of the exclusion criteria for this study during the course of the cardiac rehab sessions

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States Ascension Health Austin Texas
United States Texas A&M University College Station Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas A&M University Ascension Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in cardiac function Improvement in the 6 minute walk test performance from pre assessment to post assessment 12 weeks, 36 session cardiac rehabilitation
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