Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

Study Overview
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Brief Summary
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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 vs. 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.

Detailed Description
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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 group and individuals sessions throughout the rehabilitation continuum of care sites including: inpatient rehabilitation, day rehabilitation, and community fitness and will be 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) before HR monitoring intervention, (2) when providers know HR monitoring is occurring but without visual feedback for the group, and (3) 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, which will be further increased from pre-study baseline levels. Aim 2: Determine the efficacy of using HR with visual feedback during rehabilitation to reach target intensity. The investigators hypothesize participants will have higher mean HR and increased time in their individualized target HR zones when given visual feedback compared to no feedback during sessions. Aim 3: 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 4: 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.

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

Conditions
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Exercise Therapy, Heart Rate Determination

Intervention / Treatment
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* Device: Heart Rate Recording from Multiple Participants, No visual feedback
* Device: Visual Feedback of Multiple Participant Heart Rates


Participation Criteria
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Eligibility Criteria
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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 LVADs 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients Participants - 2 arms crossover design: Feedback will be performed, alternating 1 week without visual feedback from HR monitor and the next week with visual feedback. The week in which an individual participant enrolls in the study determines whether they first receive feedback vs no feedback during their first week (convenience-ordered crossover design). Clinician Arm: Observational sequential design. Clinicians will be observed (1) before HR monitoring intervention begins, (2) when providers know HR monitoring is occurring but without visual feedback for the group, and (3) with visual feedback of HR monitoring. After period 1, periods 2 and 3 will repeat: 1-1-1-1-2-3-2-3-2-3-2-3.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinician Arm (period 1) - behavior prior to HR intervention<br>The investigators will monitor baseline behavior of providers in regards to sessions and how frequently heart rate (HR), rating of perceived exertion (RPE) and intensity is monitored and subsequent sessions are performed/modified through observation. | |
| Active Comparator: Clinician arm (period 2) & Patient arm (control - HR monitor, no feedback)<br>Participants will receive 1 week of HR monitoring in their group sessions where visual feedback is not provided during group session. The investigators will monitor overall HR response, mean HR and time in target HR zone, RPE and clinician behavior to HR monitor on patient during these sessions. | Device: Heart Rate Recording from Multiple Participants, No visual feedback<br>* 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.<br>* Other names: Heart Zones, Inc;|
| Experimental: Clinician arm (period 3) & Patient arm (active - HR monitor, with feedback)<br>The same participants will receive 1 week of HR monitoring with visual feedback during group sessions. The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician behavior to HR monitoring with visual feedback. | Device: Visual Feedback of Multiple Participant Heart Rates<br>* 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.<br>* Other names: Heart Zones, Inc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Average Mean HR, average time in target zone | During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Self-Efficacy and Confidence | Using a scale from 0-100%, participant's will 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. | During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days) | 
| Clinician Behavior | Number of times HR, RPE, or intensity is monitored and/or modified based on feedback during rehabilitation sessions | Up to 6 months | 
| Incidence of Adverse Events | monitoring for adverse events | During therapy sessions (1-4 hours per day, up to 5 days per week) and through duration of patient's rehabilitation stay (approximately 10-90 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitals, Rehabilitation, Exercise Therapy, Heart Rate Determination, Rehabilitation Centers