跳至主要内容
临床试验/NCT05160025
NCT05160025已完成不适用

Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition

研究概览

简要总结

This study has three objectives about persons with Parkinson's Disease during bicycling:

  1. Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity
  2. Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment & perception of exercise intensity
  3. Determine if attention differs during visual feedback compared to competition virtual bicycling

详细描述

Participants will attend one sessions lasting about 2-3 hours. They will complete movement assessments and questionnaires about physical activity. They will then exercise exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 8 minutes and will be followed by questionnaires about the participant's experience.

研究设计

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

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Parkinson's disease following the UK Brain Bank Diagnostic Criteria,
  • Hoehn and Yahr stages II-III,
  • 45-80 years old,
  • Able to ride a stationary upright bicycle,
  • Able to sign informed consent.

排除标准

  • Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease,
  • Are unable to follow directions or sign a consent form,
  • Do not have adequate vision or hearing ability to see or hear a television,
  • Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle,
  • Have any other medical condition that prevents bicycling,
  • Have moderate depression (score of 9 or more on GDS screening tool).

结局指标

主要结局

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition

时间窗: Session 1 - During the 8-minute other-competition bout

Heart rate collected continuously (1 value per second, 1 Hz)

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback

时间窗: Session 1 - During the 8-minute feedback bout

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition

时间窗: Session 1 - During the 8-minute other-competition bout

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Motivation (Intrinsic Motivation Inventory) - Feedback

时间窗: Session 1 - Immediately after completing the 8-minute feedback bout

Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

Motivation (Intrinsic Motivation Inventory) - Self-Competition

时间窗: Session 1 - Immediately after completing the 8-minute self-competition bout

Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition

时间窗: Session 1 - During the 8-minute self-competition bout

Heart rate collected continuously (1 value per second, 1 Hz)

Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Self-Competition

时间窗: Session 1 - During the 8-minute self-competition bout

3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Other-Competition

时间窗: Session 1 - During the 8-minute other-competition bout

3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition

时间窗: Session 1 - During the 8-minute self-competition bout

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Motivation (Intrinsic Motivation Inventory) - Other-Competition

时间窗: Session 1 - Immediately after completing the 8-minute other-competition bout

Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Feedback

时间窗: Session 1 - During the 8-minute feedback bout

3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback

时间窗: Session 1 - During the 8-minute feedback bout

Heart rate collected continuously (1 value per second, 1 Hz)

次要结局

  • Rating of Perceived Exertion - Feedback (Start)(Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout)
  • Rating of Perceived Exertion - Feedback (Middle)(Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout)
  • Rating of Perceived Exertion - Feedback (End)(Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout)
  • Rating of Perceived Exertion - Self-Competition (Start)(Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout)
  • Rating of Perceived Exertion - Self-Competition (End)(Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout)
  • Competitiveness (Multidimensional Competitive Orientation Inventory)(Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure))
  • Rating of Perceived Exertion - Self-Competition (Middle)(Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout)
  • Rating of Perceived Exertion - Other-Competition (Middle)(Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout)
  • Ranking of Perceived Effort(Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition)
  • Ranking of Enjoyment(Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition)
  • Audio Recordings of Exercise Experience(Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition)
  • Rating of Perceived Exertion - Other-Competition (Start)(Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout)
  • Rating of Perceived Exertion - Other-Competition (End)(Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout)

研究者

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

Judith E Deutsch, PT, PhD

Professor, Department of Rehabilitation & Movement Sciences

Rutgers, The State University of New Jersey

研究点 (2)

Loading locations...

相似试验

Immersive Virtual Reality Bicycling for Persons With... | 临床试验