Exercise TherapyNCT05273801

Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

A study testing Heart Rate Recording from Multiple Participants, No Visual Feedback and Visual Feedback of Multiple Participant Heart Rates in people with Exercise Therapy and Heart Rate Determination, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Exercise Therapy, Heart Rate Determination
What is being tested?: Heart Rate Recording from Multiple Participants, No Visual Feedback and Visual Feedback of Multiple Participant Heart Rates
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 28 Jan 2022to 1 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Shirley Ryan AbilityLab
Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Exercise Therapy, Heart Rate Determination
Being tested: Heart Rate Recording from Multiple Participants, No Visual Feedback, Visual Feedback of Multiple Participant Heart Rates
Keywords: Hospitals, Rehabilitation, Exercise Therapy, Heart Rate Determination, Rehabilitation Centers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heart Rate Recording from Multiple Participants, No Visual FeedbackDevice
Also called Heart Zones, Inc
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 RatesDevice
Also called Heart Zones, Inc
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.

Study groups in NCT05273801
Study group	Role	What they receive
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. Receives: Device: Heart Rate Recording from Multiple Participants, No Visual Feedback; Device: Visual Feedback of Multiple Participant Heart Rates

What is being measured

The primary outcome is the main question the study is designed to answer.

Provider Behavior
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.
Measured: Through study completion, an average of 3 months

Secondary outcomes (1)

Patient Participant Self-Efficacy and Confidence
Using a scale from 0-100% (higher is better), participant's 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 after each session. Data from each session are averaged to create a single value per participant.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20221 May 2022

First posted10 Mar 2022
Study start28 Jan 2022
Primary completion1 May 2022
Study completion1 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Exercise TherapyStudies of the same condition, open and under way.
More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05273801
Sponsor's protocol ID: STU00216223
Status last verified: Nov 2024
First submitted: 1 Feb 2022
Last updated: 2 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pilot data of individuals clinical care with plan for future work to validate process.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
ClinicalTrials.gov ID: NCT05273801
Acronym / sponsor ID: STU00216223
Conditions: Exercise Therapy, Heart Rate Determination
Keywords: Hospitals, Rehabilitation, Exercise Therapy, Heart Rate Determination, Rehabilitation Centers
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Shirley Ryan AbilityLabUniversity, hospital or other
Study start: 28 Jan 2022 (actual)
Primary completion: 1 May 2022 (actual)
Study completion: 1 May 2022 (actual)
First posted: 10 Mar 2022 (actual)
Results: Posted 2 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Observational HR monitoring	Experimental	Device: Heart Rate Recording from Multiple Participants, No Visual Feedback, Device: Visual Feedback of Multiple Participant Heart RatesParticipants 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

Unable to provide informed consent due to cognitive impairment
Inability to communicate with investigators
Sternal Precautions
Individuals with Left Ventricular assist devices
Pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Heart Rate Recording from Multiple Participants, No Visual FeedbackAlso: Heart Zones, IncHeart 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.	Device	Observational HR monitoring
Visual Feedback of Multiple Participant Heart RatesAlso: Heart Zones, IncVisual 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.	Device	Observational HR monitoring

Primary outcome

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.

1 secondary outcome

Patient Participant Self-Efficacy and Confidence
Time frame: 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).

Results and safety

Results posted to the registry on 2 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational HR Monitoring	18	17

Primary outcome: Provider Behavior

Time frame: Through study completion, an average of 3 months. Mean (Standard Deviation). Unit: observations

Measure	HR Monitor, no Visual Feedback n = 15	HR Monitor, With Feedback n = 15
How frequently provider ask about RPE/HR during session	0.38 (0.97)	0.48 (0.90)
How frequently education provided regarding HR/RPE during session	0.62 (1.24)	1.43 (1.47)
How frequently HR/RPE target is mentioned in session	0.33 (1.11)	4.91 (7.38)
How frequently provider modifies session/task to reach HR/RPE target	0.29 (0.64)	2.17 (2.87)
How frequently providers monitor HR/RPE during session	5.14 (8.70)	20.43 (12.09)

HR Monitor, no Visual Feedback vs HR Monitor, With Feedback: p = 0.73, t-test, 2 sided
HR Monitor, no Visual Feedback vs HR Monitor, With Feedback: p = 0.05, t-test, 2 sided
HR Monitor, no Visual Feedback vs HR Monitor, With Feedback: p = 0.007, t-test, 2 sided

Population analysed: Participants are part of one arm and may have been observed in either of these assigned interventions. For clarity, assigned intervention are separated into "arms". Participants analyzed in each intervention group are \<17 because not all participants received each intervention due to medical care (unexpected discharge, transfer to acute hospital, schedule). Providers were not consented to the study so were not considered enrolled. Provider Behavior data were not collected from providers.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study completion, an average of 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HR Monitor, no Feedback	0 of 15 (0%)	0 of 15 (0%)	0 of 15
HR Monitor, With Feedback	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): Heart rate data collected from multiple brands of devices due to readability issue in some patients. Some patients' peripheral circulation and use of devices affected HR transmission; thus possibly affecting reliability and consistency of heart rate data collected in sessions. Given this, clinician's behavior may have been affected when providing visual feedback. This data served as pilot exploratory data for future work.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Pilot data of individuals clinical care with plan for future work to validate process.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miriam Rafferty, DPT, PhD principal investigator

Shirley Ryan AbilityLab

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Provider Behavior (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.