Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05273801
Status:
UNKNOWN
Last Update Posted:
2022-03-10
First Post:
2022-02-01
Brief Title:
Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Assessing Feasibility Efficacy and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None