The Effect of Bottle PEP Exercise on Expiratory Muscle Thickness, Strength, and Balance Parameters in Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Diaphragm and intercostal muscle thickness
研究概览
简要总结
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, tremor, postural instability, bradykinesia, and autonomic dysfunction. It is a common movement disorder worldwide. Motor impairments in PD patients are not limited to the muscles of the extremities; the neck, upper respiratory tract, and respiratory muscles are also affected. The resulting pulmonary dysfunction is one of the main factors contributing to morbidity and mortality in PD patients.
Respiratory muscle exercise programs have been used to improve lung and swallowing function in patients with Parkinson's disease and other similar neurodegenerative disorders. Studies of inspiratory muscle exercise in Parkinson's patients have reported improvements in inspiratory muscle strength and endurance. Similarly, expiratory muscle exercise protocols have been shown to increase maximum expiratory pressure (MEP) and cough effectiveness. However, studies on expiratory muscle strengthening are lacking in the literature.
Positive expiratory pressure (PEP) devices are used to clear airway secretions and feature a resistance that provides resistance during exhalation. This creates a positive pressure that stabilizes the airways during exhalation and prevents airway collapse. Although there are many PEP devices available on the market, the bottle-PEP, a therapist-made device, is used because it can be produced easily and at low cost. The bottle-PEP device consists of a bottle filled with at least 10 cm of water and a tube placed inside the bottle. Although information on strengthening expiratory muscles is traditionally found in the literature, there is no data in the literature on the effect of bottle-PEP use on expiratory muscle strength, especially in Parkinson's patients. A review of the literature shows that the effect of expiratory strengthening on balance has not been studied before.
This study aimed to demonstrate the effects of the bottle-PEP device, used in addition to expiratory muscle strengthening, on expiratory muscle thickness, strength, and balance.
详细描述
Our study was designed as a single-blind prospective study. Patients enrolled in the study will be divided into two groups using a computer-assisted list.
Group 1: Neurological rehabilitation program + expiratory strengthening exercises Group 2: Neurological rehabilitation program + bottle-PEP (Positive expiratory pressure (PEP))
The first group will undergo expiratory breathing strengthening exercises, which are part of routine practice, five days a week in addition to the neurological rehabilitation program for Parkinson's disease. The expiratory muscle strengthening exercises are detailed in Appendix 2. The second group will undergo bottle-PEP exercises 5 days a week, performing 25 forced expirations after deep inspirations using a homemade bottle-PEP device, in addition to the neurological rehabilitation program for Parkinson's disease. The bottle-PEP device is created by filling a 1.5-liter plastic, empty, and clean bottle with 10 cm of water and then immersing an aspiration tube into this water. After deep inspiration, the patient takes the aspiration tube into their mouth and performs forced expiration against the water. The exercises are designed as an 8-week home program. Both the neurological rehabilitation program and expiratory breathing strengthening exercises are routine programs.
Patients will be taught how to use the bottle-PEP and perform the exercises face-to-face during the first visit.
To monitor the implementation of this program, a researcher will confirm that the exercises are being performed correctly via video calls with the participants over the internet.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed Parkinson's diagnosis who are being monitored
- •Those aged 18-75
- •Patients who are ambulatory
排除标准
- •Patients with acquired primary motor neuron disease (ischemic/hemorrhagic stroke, intracranial mass) and additional neurological diagnoses
- •Patients with hearing and cognitive impairments that prevent them from understanding or performing the exercise program
- •Presence of concomitant acute or chronic lung disease
- •History of thoracic or abdominal surgery
- •Severe heart disease
- •Active cancer
- •Mini-Mental State Examination (MMSE) score ≤ 24
- •Active smoking
结局指标
主要结局
Diaphragm and intercostal muscle thickness
时间窗: Will be performed using an ultrasound device before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week)
In this study, ultrasonography will be used to measure muscle thickness at the end of inspiration and expiration. The thickness of the diaphragm and intercostal muscles will be measured in millimeters.
次要结局
- Pulmonary Function Tests(Will be measured using spirometry before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week))
- Berg Balance Scale(Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).)
- Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements(Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).])
- Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).])