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Clinical Trials/NCT05273801
NCT05273801
Completed
Not Applicable

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

Shirley Ryan AbilityLab1 site in 1 country18 target enrollmentJanuary 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise Therapy
Sponsor
Shirley Ryan AbilityLab
Enrollment
18
Locations
1
Primary Endpoint
Provider Behavior
Status
Completed
Last Updated
last year

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. 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.

Registry
clinicaltrials.gov
Start Date
January 28, 2022
End Date
May 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miriam Rafferty

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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).)

Study Sites (1)

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