Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

Not Applicable

Completed

Conditions: Exercise Therapy
Heart Rate Determination

Interventions: Device: Heart Rate Recording from Multiple Participants, No visual feedback
Device: Visual Feedback of Multiple Participant Heart Rates

Registration Number: NCT05273801

Lead Sponsor: Shirley Ryan AbilityLab

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinician arm (period 2) & Patient arm (control - HR monitor, no feedback)	Heart Rate Recording from Multiple Participants, No visual feedback	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.
Clinician arm (period 3) & Patient arm (active - HR monitor, with feedback)	Visual Feedback of Multiple Participant Heart Rates	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.

Primary Outcome Measures

Name	Time	Method
Provider Behavior	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.

Secondary Outcome Measures

Name	Time	Method
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).	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.