Wearables and Cardiac Rehabilitation | NCT06065319

Studies
Wearables and Cardiac Rehabilitation

NCT06065319

Sponsor

Texas A&M University

Status

Active, not recruiting

Last Update Posted

Sep 23, 2024Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Cardiac Rehabilitation

Interventions

Wearable Sensors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Aug 28, 2023

First Submission Date that Met QC Criteria

Sep 26, 2023

First Posted Date

Oct 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 23, 2024Actual

Name	Class
Ascension Health	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All Comers to Cardiac Rehabilitation		Any participant that is enrolled in cardiac rehabilitation is eligible for this study.	Device: Wearable Sensors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wearable Sensors	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All-comers to cardiac rehabilitation who are capable of using smartphones for remote data collection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kurian	Ascension Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ascension Health		Austin	Texas	78705	United States
Texas A&M University

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Deidentified wearable data and 6minute walk data will be made available, upon reasonable request, for other researchers

Types

Study Protocol
Informed Consent Form (ICF)
Analytic Code

Time Frame

At the end of the study and for at least 3 years

Access Criteria

Reasonable request and data use agreement with investigators

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 11, 2023	Sep 1, 2023	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Aug 14, 2023	Aug 28, 2023	ICF_001.pdf