Exercise Therapy, Heart Rate Determination
Conditions
Keywords
Hospitals, Rehabilitation, Exercise Therapy, Heart Rate Determination, Rehabilitation Centers
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.
Interventions
DEVICEHeart 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.
DEVICEVisual 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.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
All individuals involved in the study will be aware when HR feedback as well as monitoring occurs during the study.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Behavior | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Participant Self-Efficacy and Confidence | 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). | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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, 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. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Observational HR Monitoring | — |
|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 13.3 | — |
| Number of Participants on Beta Blocker Medications | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HR Monitor, no Visual Feedback | Provider Behavior | How frequently education provided regarding HR/RPE during session | 0.62 observations | Standard Deviation 1.24 |
| HR Monitor, no Visual Feedback | Provider Behavior | How frequently provider modifies session/task to reach HR/RPE target | 0.29 observations | Standard Deviation 0.64 |
| HR Monitor, no Visual Feedback | Provider Behavior | How frequently HR/RPE target is mentioned in session | 0.33 observations | Standard Deviation 1.11 |
| HR Monitor, no Visual Feedback | Provider Behavior | How frequently providers monitor HR/RPE during session | 5.14 observations | Standard Deviation 8.7 |
| HR Monitor, no Visual Feedback | Provider Behavior | How frequently provider ask about RPE/HR during session | 0.38 observations | Standard Deviation 0.97 |
| HR Monitor, With Feedback | Provider Behavior | How frequently providers monitor HR/RPE during session | 20.43 observations | Standard Deviation 12.09 |
| HR Monitor, With Feedback | Provider Behavior | How frequently provider ask about RPE/HR during session | 0.48 observations | Standard Deviation 0.9 |
| HR Monitor, With Feedback | Provider Behavior | How frequently education provided regarding HR/RPE during session | 1.43 observations | Standard Deviation 1.47 |
| HR Monitor, With Feedback | Provider Behavior | How frequently HR/RPE target is mentioned in session | 4.91 observations | Standard Deviation 7.38 |
| HR Monitor, With Feedback | Provider Behavior | How frequently provider modifies session/task to reach HR/RPE target | 2.17 observations | Standard Deviation 2.87 |
Comparison: How frequently clinician ask about RPE/HR during sessionp-value: 0.73t-test, 2 sided
Comparison: How frequently education provided regarding HR/RPE during sessionp-value: 0.05t-test, 2 sided
Comparison: How frequently HR/RPE target is mentioned in sessionp-value: 0.007t-test, 2 sided
Comparison: How frequently clinician modifies session/task to reach HR/RPE targetp-value: 0.005t-test, 2 sided
Comparison: How frequently clinicians monitor HR/RPE during sessionp-value: 0.00001t-test, 2 sided
Secondary
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.
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HR Monitor, no Visual Feedback | 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 |
| HR Monitor, no Visual Feedback | 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 |
| HR Monitor, With Feedback | Patient Participant Self-Efficacy and Confidence | Patient self-confidence (0-100%) reaching target intensity in session. | 77.5 score on a scale | Standard Deviation 24.3 |
| HR Monitor, With Feedback | Patient Participant Self-Efficacy and Confidence | Patient self-rating of confidence to continue to reach target without HR monitor in future (0-100%) | 79.3 score on a scale | Standard Deviation 20.4 |