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Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

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Shirley Ryan AbilityLab

Status

Completed

Conditions

Heart Rate Determination
Exercise Therapy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05273801
STU00216223

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Observational HR monitoring
Experimental group
Description:
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.
Treatment:
Device: Visual Feedback of Multiple Participant Heart Rates
Device: Heart Rate Recording from Multiple Participants, No Visual Feedback

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Miriam Rafferty, DPT, PhD; Kristen Hohl, DPT

Data sourced from clinicaltrials.gov

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