Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range.
The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.
A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between the ages of 18-65
- •Answering "No" to the general health questions of the Exercise Readiness Questionnaire for all
排除标准
- •Being an amateur or professional athlete who does sports-specific training at least 2 times a week
- •Having a chronic disease
- •Having history of spontaneous or trauma-related pneumothorax
- •Having pathologies related to the middle ear (such as tympanic membrane rupture, otitis)
- •Receiving routine medical treatment other than vitamin supplements for any reason
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: 8 weeks
Maximal Inspiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Forced Vital Capacity (FVC)
时间窗: 8 weeks
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Flow 25-75% (FEF25-75)
时间窗: 8 weeks
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Maximal Expiratory Pressure (MEP)
时间窗: 8 weeks
Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Peak Expiratory Flow (PEF)
时间窗: 8 weeks
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Volume in 1 second (FEV1)
时间窗: 8 weeks
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Spiropalm 6-minute Walk Test
时间窗: 8 weeks
The 6-minute Walk Test will be performed with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
次要结局
- Convenience of Device Use(8 weeks)
研究者
Hikmet Ucgun
Assistant Professor
Biruni University