Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

Exercise Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273801
• Other study ID #: STU00216223
• Status: Recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Shirley Ryan AbilityLab
• Contact: Miriam Rafferty, DPT, PhD
• Phone: 312-238-7233
• Email: mrafferty[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 vs. 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.

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 group and individuals sessions throughout the rehabilitation continuum of care sites including: inpatient rehabilitation, day rehabilitation, and community fitness and will be 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) before HR monitoring intervention, (2) when providers know HR monitoring is occurring but without visual feedback for the group, and (3) 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, which will be further increased from pre-study baseline levels.

Aim 2: Determine the efficacy of using HR with visual feedback during rehabilitation to reach target intensity.

The investigators hypothesize participants will have higher mean HR and increased time in their individualized target HR zones when given visual feedback compared to no feedback during sessions.

Aim 3: 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 4: 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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 LVADs

• 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

Related Conditions & MeSH terms

• Exercise Therapy
• Heart Rate Determination

Intervention

Device:
• Heart Rate Recording from Multiple Participants, No visual feedback
Heart rates are recorded from multiple participants during the group sessions. However during this intervention, it will not be cast to a TV for feedback to the participant or clinician.
• Visual Feedback of Multiple Participant Heart Rates
Visual feedback of HR is provided through a 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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Average Mean HR, average time in target zone	During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)
Secondary	Clinician Behavior	Number of times HR, RPE, or intensity is monitored and/or modified based on feedback during rehabilitation sessions	Up to 6 months
Secondary	Incidence of Adverse Events	monitoring for adverse events	During therapy sessions (1-4 hours per day, up to 5 days per week) and through duration of patient's rehabilitation stay (approximately 10-90 days)
Secondary	Participant Self-Efficacy and Confidence	Using a scale from 0-100%, participant's will 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.	During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)