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临床试验/NCT05273801
NCT05273801已完成不适用

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

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Provider Behavior

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

盲法说明

All individuals involved in the study will be aware when HR feedback as well as monitoring occurs during the study.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Heart Rate Recording from Multiple Participants, No Visual Feedback (Device)

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.

干预措施: Visual Feedback of Multiple Participant Heart Rates (Device)

结局指标

主要结局

Provider Behavior

时间窗: 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.

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miriam Rafferty

Principal Investigator

Shirley Ryan AbilityLab

研究点 (1)

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