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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Participant Self-Efficacy and Confidence | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Rafferty, DPT, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
Pilot data of individuals clinical care with plan for future work to validate process.
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17 of 18 participants were included. One participant did not meet inclusion criteria. Observed providers were not consented to the study so were not considered enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational HR Monitoring | Participants were observed in 2 conditions: 1) HR monitoring without visual feedback and 2) HR monitoring with visual feedback. 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only one arm is described because the same unique participants participated in 2 conditions (HR monitoring with visual feedback, HR monitoring without visual feedback), however not in a formal structured crossover design to allow separation. One arm is required for accurate demographic reporting (n total 18 consented, 17 participants at baseline). Providers were not consented to the study so were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational HR Monitoring | Participants were observed in 2 conditions: 1) HR monitoring without visual feedback and 2) HR monitoring with visual feedback. The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants are part of one arm and may have been observed in either of these assigned interventions. For clarity, assigned intervention are separated into "arms". Participants analyzed in each intervention group are <17 because not all participants received each intervention due to medical care (unexpected discharge, transfer to acute hospital, schedule). Providers were not consented to the study so were not considered enrolled. Provider Behavior data were not collected from providers. | Posted | Mean | Standard Deviation | observations | Through study completion, an average of 3 months | session count | session count |
|
Through study completion, an average of 3 months
Adverse event collection occurred at end of each data collection session. The number of participants potentially at risk is <17 because not all participants received each intervention due to medical care (unexpected discharge, transfer to acute hospital, schedule). Providers were not consented to the study so were not considered enrolled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HR Monitor, no Feedback | Participants will have 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 provider behavior to HR monitor on patient during these sessions. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Miriam Rafferty | Shirley Ryan AbilityLab | 3122387233 | mrafferty@sralab.org |
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| 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 | Feb 11, 2022 | Nov 15, 2022 | Prot_SAP_000.pdf |
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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.
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All individuals involved in the study will be aware when HR feedback as well as monitoring occurs during the study.
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| 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. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Number of Participants on Beta Blocker Medications | Count of Participants | Participants |
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Participants will have HR monitoring in their group sessions where visual feedback is not provided. 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.
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. Participants listed is number of sessions observed.
| OG001 | HR Monitor, With Feedback | Participants will have 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. 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. Participants listed is number of sessions observed. |
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| Secondary | Patient Participant Self-Efficacy and Confidence | 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. | Participants are part of one arm and may have been observed in either of these assigned interventions. For clarity, assigned intervention are separated into "arms". Participants analyzed in each intervention group are <17 because not all participants received each intervention due to medical care (unexpected discharge, transfer to acute hospital, schedule). Providers were not consented to the study so were not considered enrolled. | Posted | Mean | Standard Deviation | score on a scale | 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). |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | HR Monitor, With Feedback | Participants will have 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 provider behavior to HR monitoring with visual feedback. 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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