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Trial Outcomes & Findings for Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot (NCT NCT05273801)

NCT ID: NCT05273801

Last Updated: 2024-12-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Through study completion, an average of 3 months

Results posted on

2024-12-02

Participant Flow

17 of 18 participants were included. One participant did not meet inclusion criteria. Observed providers were not consented to the study so were not considered enrolled

Participant milestones

Participant milestones
Measure
Observational HR Monitoring
Participants were observed in 2 conditions: 1) HR monitoring without visual feedback and 2) HR monitoring with visual feedback. 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 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.
Overall Study
STARTED
18
Overall Study
Number of Participants Who Recieved HR Monitoring Without Visual Feedback
15
Overall Study
Number of Participants Who Received HR Monitoring With Visual Feedback
15
Overall Study
COMPLETED
17
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Observational HR Monitoring
Participants were observed in 2 conditions: 1) HR monitoring without visual feedback and 2) HR monitoring with visual feedback. 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 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.
Overall Study
Physician Decision
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observational HR Monitoring
n=17 Participants
Participants were observed in 2 conditions: 1) HR monitoring without visual feedback and 2) HR monitoring with visual feedback. The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician 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 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.
Age, Continuous
54.7 years
STANDARD_DEVIATION 13.3 • n=17 Participants
Sex: Female, Male
Female
8 Participants
n=17 Participants
Sex: Female, Male
Male
9 Participants
n=17 Participants
Number of Participants on Beta Blocker Medications
8 Participants
n=17 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 3 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure
HR Monitor, no Visual Feedback
n=31 session count
Participants will have HR monitoring in their group sessions where visual feedback is not provided. The investigators will monitor overall HR response, mean HR and time in target HR zone, RPE and clinician behavior to HR monitor on patient during these sessions. 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. Participants listed is number of sessions observed.
HR Monitor, With Feedback
n=28 session count
Participants will have HR monitoring with visual feedback during group sessions. The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician behavior to HR monitoring with visual feedback. 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. Participants listed is number of sessions observed.
Provider Behavior
How frequently provider ask about RPE/HR during session
0.38 observations
Standard Deviation 0.97
0.48 observations
Standard Deviation 0.90
Provider Behavior
How frequently education provided regarding HR/RPE during session
0.62 observations
Standard Deviation 1.24
1.43 observations
Standard Deviation 1.47
Provider Behavior
How frequently HR/RPE target is mentioned in session
0.33 observations
Standard Deviation 1.11
4.91 observations
Standard Deviation 7.38
Provider Behavior
How frequently provider modifies session/task to reach HR/RPE target
0.29 observations
Standard Deviation 0.64
2.17 observations
Standard Deviation 2.87
Provider Behavior
How frequently providers monitor HR/RPE during session
5.14 observations
Standard Deviation 8.70
20.43 observations
Standard Deviation 12.09

SECONDARY outcome

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).

Population: 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.

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.

Outcome measures

Outcome measures
Measure
HR Monitor, no Visual Feedback
n=15 Participants
Participants will have HR monitoring in their group sessions where visual feedback is not provided. The investigators will monitor overall HR response, mean HR and time in target HR zone, RPE and clinician behavior to HR monitor on patient during these sessions. 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. Participants listed is number of sessions observed.
HR Monitor, With Feedback
n=15 Participants
Participants will have HR monitoring with visual feedback during group sessions. The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician behavior to HR monitoring with visual feedback. 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. Participants listed is number of sessions observed.
Patient Participant Self-Efficacy and Confidence
Patient self-confidence (0-100%) reaching target intensity in session.
72.9 score on a scale
Standard Deviation 25.9
77.5 score on a scale
Standard Deviation 24.3
Patient Participant Self-Efficacy and Confidence
Patient self-rating of confidence to continue to reach target without HR monitor in future (0-100%)
85.0 score on a scale
Standard Deviation 19.2
79.3 score on a scale
Standard Deviation 20.4

Adverse Events

HR Monitor, no Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HR Monitor, With Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miriam Rafferty

Shirley Ryan AbilityLab

Phone: 3122387233

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place