Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

November 27, 2024 updated by: Miriam Rafferty, Shirley Ryan AbilityLab

Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

The purpose of this investigation is to determine if knowledge of heart rate (HR) and target HR zones (HRzone), with visual feedback vs no feedback of HR or HRzone improves patient exercise intensity during rehabilitation. The central hypothesis for this study is with visual feedback of HR and target HR zones with instruction about exercise intensity and targets will increase patient HR intensity during sessions within a safe range set by their medical team. For purposes of this study, patients will be monitored in inpatient sessions and is inclusive of all individuals with chronic health conditions. Physical activity and exercise guidelines recommend everyone, including those with chronic health conditions, strive for 150 minutes of moderate intensity aerobic exercise per week. This study will contribute to the knowledge of how patients achieve recommended individual HR and moderate-high intensity zones during exercise.

Aim 1: Measure the extent to which monitoring and education regarding intensity is provided (1) when providers know HR monitoring is occurring but without visual feedback for the group, and (2) with visual feedback of HR monitoring in a group setting.

The investigators hypothesize providers will modify their behavior in the number of times they ask about intensity, adjust session intensity or provide education regarding intensity when visual feedback is provided compared to no feedback.

Aim 2: Determine the safety of using Heart Zones technology in rehabilitation settings for increasing participant exercise intensity.

The investigators hypothesize the technology will be safe without an increase in number of adverse events throughout their rehabilitation stay.

Aim 3: Assess patient acceptability, exercise self-efficacy and confidence following use of Heart Zones technology in group settings.

The investigators hypothesize use of Heart Zones technology in rehabilitation with feedback will increase participant self-efficacy and confidence in reaching higher exercise intensities, and will be well accepted.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan AbilityLab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observational HR monitoring

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: Visual Feedback of Multiple Participant Heart Rates
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.
Other Names:
  • Heart Zones, Inc
Device: Heart Rate Recording from Multiple Participants, No Visual Feedback
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.
Other Names:
  • Heart Zones, Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Behavior
Time Frame: Through study completion, an average of 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Participant Self-Efficacy and Confidence
Time Frame: 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).
Using a scale from 0-100% (higher is better), participant's rate their self-efficacy and confidence in their ability to achieve target exercise intensity and confidence in performing the activity without a heart rate monitor after each session. Data from each session are averaged to create a single value per participant.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Miriam Rafferty, DPT, PhD, Shirley Ryan AbilityLab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2022

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00216223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pilot data of individuals clinical care with plan for future work to validate process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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