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Clinical Trials/NCT05273801
NCT05273801CompletedNot Applicable

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

Shirley Ryan AbilityLab1 site in 1 country18 target enrollmentStarted: January 28, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Provider Behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Masking Description

All individuals involved in the study will be aware when HR feedback as well as monitoring occurs during the study.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Heart Rate Recording from Multiple Participants, No Visual Feedback (Device)

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.

Intervention: Visual Feedback of Multiple Participant Heart Rates (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Miriam Rafferty

Principal Investigator

Shirley Ryan AbilityLab

Study Sites (1)

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