Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

NCT05273801 | Completed Results

• 1 other identifier: STU00216223
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Monitoring heart rate during exercise can provide feedback to the patient and provider that the patient is exercising in the appropriate, individualized and safe range for them. This is particularly important in a group setting when multiple individuals are supervised by one provider. This study is interested in assessing the difference in intensity of care delivered when visual feedback of heart rate is provided compared to no visual feedback of heart rate in rehabilitation. Visual feedback of heart rate will be provided through Heart Zones, a platform which synthesizes multiple signals from externally worn heart rate monitors. This study is interested in better understanding the acceptability, feasibility and appropriateness of this technology when used in rehabilitation.

Conditions

Exercise Therapy; Heart Rate Determination

Keywords

Hospitals, Rehabilitation; Exercise Therapy; Heart Rate Determination; Rehabilitation Centers

Outcome Measures

Primary Outcomes (1)

• Provider Behavior

  Number of times heart rate (beats/minute), Rate of perceived exertion (6-20, higher = greater perceived exertion) or intensity (asked in session by HR/RPE) is monitored and/or modified based on feedback during rehabilitation sessions.

  Through study completion, an average of 3 months

Secondary Outcomes (1)

• Patient Participant Self-Efficacy and Confidence

  Assessed during therapy sessions (1-4 hrs/day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 5-60 days).

Study Arms (1)

Observational HR monitoring

EXPERIMENTAL

Participants will receive 2 intervention conditions: HR monitoring with visual feedback, and HR monitoring without visual feedback. Observed condition will alternate by session. The investigators will monitor overall HR response, mean time HR and time in target zone, Rate of perceived exertion (RPE), and provider behavior to HR monitoring prior to HR monitoring, with visual feedback and without visual feedback. Visual Feedback of Multiple Participant Heart Rates: Visual feedback of HR is provided through a television (TV) monitor. Multiple heart rates can be displayed and recorded simultaneously allowing for group encouragement, continuous monitoring and adjustment of all participants to ensure reaching appropriate target intensity.

Device: Heart Rate Recording from Multiple Participants, No Visual Feedback; Device: Visual Feedback of Multiple Participant Heart Rates

Interventions

Heart Rate Recording from Multiple Participants, No Visual Feedback DEVICE

Heart rates are recorded from multiple participants during the group sessions. However during this intervention, it will not be cast to a TV for feedback to the participant or clinician.

Also known as: Heart Zones, Inc

Observational HR monitoring

Visual Feedback of Multiple Participant Heart Rates DEVICE

Visual feedback of HR is provided through a TV monitor. Multiple heart rates can be displayed and recorded simultaneously allowing for group encouragement, continuous monitoring and adjustment of all participants to ensure reaching appropriate target intensity.

Also known as: Heart Zones, Inc

Observational HR monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to inpatient rehabilitation, day rehabilitation or participant in community fitness
• Qualifies for group therapy based on diagnosis and insurance reimbursement
• Physician clearance for participation

You may not qualify if:

• Unable to provide informed consent due to cognitive impairment
• Inability to communicate with investigators
• Sternal Precautions
• Individuals with Left Ventricular assist devices
• Pregnant women
• Uncontrolled Hypertension
• Serious and unstable cardiac arrhythmias
• Loss of bilateral upper extremity sensation
• At high risk for skin breakdown due to poor skin integrity (open wound, fragile skin, etc)
• Previous participation in this study while in another level of care in the last 6 months

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Limitations and Caveats

Heart rate data collected from multiple brands of devices due to readability issue in some patients. Some patients' peripheral circulation and use of devices affected HR transmission; thus possibly affecting reliability and consistency of heart rate data collected in sessions. Given this, clinician's behavior may have been affected when providing visual feedback. This data served as pilot exploratory data for future work.

Results Point of Contact

• Title: Dr. Miriam Rafferty
• Organization: Shirley Ryan AbilityLab

mrafferty@sralab.org

3122387233

Study Officials

• Miriam Rafferty, DPT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All individuals involved in the study will be aware when HR feedback as well as monitoring occurs during the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be enrolled in a single arm where they may receive HR monitoring with visual feedback or HR monitoring with no visual feedback. Observed condition will alternate by session.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 10, 2022
• Study Start: January 28, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)