Clinical trial NCT05273801: Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot
Official title: Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Heart Rate Determination
Keywords: Hospitals, Rehabilitation
Exercise Therapy
Heart Rate Determination
Rehabilitation Centers
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Provider Behavior
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Patient Participant Self-Efficacy and Confidence
timeFrame: 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).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Miriam Rafferty, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: