Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Perceived difficulty inhaling against each respiratory resistive load.
研究概览
简要总结
The purpose of this study is to determine whether people with Parkinson's disease (PD) experience reduced perception of respiratory resistive loads versus healthy adults in the same age group. Further, the study will determine whether people with PD and trouble swallowing experience even more reduction of their perception of a respiratory resistive load.
详细描述
Experimental design and procedures: This prospective experimental study will be completed in one study visit taking between 1 and 3 hours. Verbal and written informed consent will be obtained by qualified members of the investigative team. Following informed consent, all participants will complete a health history questionnaire to assess inclusion/exclusion criteria. For patients with PD the consenting investigator will review the electronic medical record to ensure inclusion/exclusion criteria are met.
The experimental protocol will consist of 1.) Baseline pulmonary function measures, 2.) Baseline measures of depression and apathy, 3.) Presentation of resistive inspiratory loads via respiratory equipment, and 4.) Rating the perceived magnitude of respiratory sensations as measured on a modified Borg scale (ranging from 6 - no breathing difficulty - to 20 - maximal difficulty). For patients with PD only, the investigators will also review results of the rehabilitation barium swallow study performed as part of their standard clinical care.
Baseline Pulmonary function measures: The forced expired volume in the first second (FEV1) of a forced vital capacity (FVC) exhalation will be measured for each participant. Maximum inspiratory pressure (PiMax) will be measured with a manometer. The PiMax test will be repeated until 3 measurements within 10% variation are obtained, with at least 1 minute rest between trials.
Baseline depression and apathy: There is a significant impact for emotion on respiratory perceptual ratings. As such, we will measure baseline depression and apathy scores using 2 validated scales, the Beck Depression Index (BDI) and Marin Apathy Index (MAI). These are not outcome measures, but will be used to determine exclusion criteria.
Should depression (17 or greater on BDI) be detected in a participant, that participant will be provided with contact information for the University of Florida (UF) psychiatry and psychology clinic and encouraged to seek further evaluation. In the case severe depression is detected (31 or greater on BDI) the participant will not continue with the study, and will be provided with contact information for the UF psychiatry and psychology clinic and encouraged to seek further evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 45 and 85
- •Ability to provide informed consent
- •Patient group: Diagnosis of PD, Hoehn and Yahr stages II - IV, by a UF Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict UF brain bank criteria.
- •Healthy older adults: History of PD, or any other neurologic or neurodegenerative disease including stroke.
排除标准
- •History of head and neck cancer, and radiation treatment to the head or neck
- •History of breathing disorders or diseases (e.g. chronic obstructive pulmonary disease (COPD), asthma, lung cancer)
- •History of smoking in the past 5 years, or for more than 5 years at any one time
- •Severe cognitive deficits including dementia.
- •Difficulty complying with protocol due to severe neuropsychological disorder (i.e., severe depression: 31 or greater on the BDI)
结局指标
主要结局
Perceived difficulty inhaling against each respiratory resistive load.
时间窗: Baseline
Participants will rate the level of difficulty when inhaling against different levels of resistive load. The Borg scale ranges from 6-20, where 6 is 'no difficulty' and 20 is 'maximal difficulty.'
次要结局
- The amount of pressure generated while inhaling against each resistive load(Baseline)