The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Peak Expiratory Flow Rate (PEFR)
研究概览
简要总结
This study aims to investigate the effects of different types of respiratory muscle training on lung function, diaphragm movement, and voice quality in patients with Parkinson's disease (PD). PD often leads to breathing difficulties and voice abnormalities due to weakened respiratory muscles and reduced diaphragm mobility. The study will involve 45 participants with PD, randomly assigned to three groups: one group will perform inspiratory muscle training, the second group will perform both inspiratory and expiratory muscle training, and the third group will receive placebo-controlled expiratory muscle training. The hypothesis is that targeted respiratory muscle training will significantly improve pulmonary function, diaphragm excursion, and phonatory measures compared to the placebo group. The findings aim to develop effective rehabilitation strategies to enhance the quality of life and communication abilities in individuals with PD.
详细描述
This study aims to investigate the effects of respiratory muscle training on pulmonary function, diaphragm excursion, and phonatory measures in patients with Parkinson's disease (PD). PD often leads to weakened respiratory muscles, reduced diaphragm movement, and voice abnormalities, impacting breathing and communication. The study will recruit 45 patients with PD, who will be randomly assigned to three groups: an inspiratory muscle training group, a combined inspiratory and expiratory muscle training group, and a placebo-controlled expiratory muscle training group. Over eight weeks, participants will perform daily training sessions, with the intensity of the exercises adjusted periodically. Assessments will include pulmonary function tests, ultrasound measurements of diaphragm thickness and movement, and various phonatory evaluations. The hypothesis is that respiratory muscle training will significantly improve respiratory and phonatory functions in PD patients compared to placebo, providing insights into effective rehabilitation strategies for enhancing their quality of life and communication abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease (Hoehn & Yahr stage I-III),
- •Patients aged 30-85
- •Patients with stable medical condition, regular medication adherence, and ability to follow instructions.
排除标准
- •Patients with cognitive impairment
- •Patients with respiratory or other neurological diseases
- •Patients with smoking history
- •Patients with respiratory complications
- •Patients with recent chest/abdominal surgery
- •Patients with clinical instability
- •Patients who are unable to perform pulmonary function tests correctly
结局指标
主要结局
Peak Expiratory Flow Rate (PEFR)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the peak expiratory flow rate (PEFR) to evaluate participants' lung function.
Forced Vital Capacity (FVC)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the forced vital capacity (FVC) to evaluate the maximum amount of air a person can forcibly exhale from the lungs after taking the deepest breath possible.
Maximal Inspiratory Pressure (MIP)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the maximal inspiratory pressure (MIP) to evaluate the strength of respiratory muscles during inhalation.
Speech Rate
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess speech rate to evaluate the speed at which a participant speaks.
Voice Loudness
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess voice loudness to evaluate the volume level of a participant's voice.
Forced Expiratory Volume in One Second (FEV1)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the forced expiratory volume in one second (FEV1) to evaluate how much air a person can forcibly exhale in one second.
Maximal Expiratory Pressure (MEP)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the maximal expiratory pressure (MEP) to evaluate the strength of respiratory muscles during exhalation.
Maximum Phonation Time
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess the maximum phonation time to evaluate the duration a participant can sustain a vowel sound.
Voice Intensity
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess voice intensity to evaluate the loudness of a participant's voice.
Speech Pauses
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess speech pauses to evaluate the frequency and duration of pauses in a participant's speech.
Voice Handicap Index (VHI-10)
时间窗: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
This measure will assess vocal performance using the Voice Handicap Index (VHI-10) questionnaire. The VHI-10 scores range from 0 to 40, with higher scores indicating a greater perception of vocal handicap. The score interpretation is as follows: 0-10 (no or minimal handicap), 11-20 (mild handicap), 21-30 (moderate handicap), and 31-40 (severe handicap).
次要结局
- Diaphragm Thickness(Measurements will be taken at baseline (week 0) and after the intervention period (week 8).)
- Diaphragm Excursion(Measurements will be taken at baseline (week 0) and after the intervention period (week 8).)