Investigation of Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure in Chronic Obstructive Pulmonary Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Clinical status follow-up after bronchoscopic procedure
研究概览
简要总结
The aim of this study is to examine the effectiveness of inspiratory muscle training (IMT) before bronchoscopic procedure in Chronic Obstructive Pulmonary Patients (COPD). Patients with a diagnosis of COPD, who are listed for a bronchoscopic procedure and referred to the pulmonary rehabilitation (PR) clinic, will be randomly divided into two groups. Standard PR exercise program will be applied to both groups. In addition to the standard program, IMT will be applied to one of the groups. The effect of IMT on exercise program gains will be examined.
详细描述
- Cases diagnosed with COPD by a chest diseases specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study.
- The cases meeting the inclusion criteria will be randomized and divided into two groups, called the standard rehabilitation group (PRGr) and the inspiratory muscle training group (IMTGr).
- Initial exercise sessions and all evaluations of all cases will be performed in the hospital. The 2nd and 3rd training repetitions will be held at their homes via online synchronized videoconferencing. The exercise video will be sent to the smart phones of the cases who have completed 3 training sessions. Participants will be called once a week by phone and exercise follow-up will be carried out.
- All subjects will continue to exercise 5 days a week for 2 months. The standard PR consists of breathing exercises, peripheral muscle strength and self walking training. In addition, IMT was applied to IMTGr.
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
- Single (Participant)
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
- •Being between the ages of 18-75
- •Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to -American Thoracic and European Respiratory Societies (ATS-ERS) and being a candidate patient for bronchoscopic lung volume reduction procedure
- •Presence of dyspnea on exertion
- •Stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks
- •Ability to use a smart phone
排除标准
- •Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
- •A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- •Participation in a pulmonary rehabilitation program within the past 12 months.
结局指标
主要结局
Clinical status follow-up after bronchoscopic procedure
时间窗: Change from baseline at 1 year after bronchoscopic procedure
Complications and clinical status will be followed up for 1 year after the bronchoscopic procedure.
Dyspnea perception
时间窗: Change from baseline at 2 months
Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Exercise capacity
时间窗: Change from baseline at 2 months
The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.
Respiratory muscle strength
时间窗: Change from baseline at 2 months
The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.
次要结局
- Anxiety level(Change from baseline at 2 months)
- Fatigue severity(Change from baseline at 2 months)
- Quality of life level(Change from baseline at 2 months)
- Pulmonary function tests (PFTs)(Change from baseline at 2 months)
- Depression level(Change from baseline at 2 months)
- Peripheral muscle strength measurement(Change from baseline at 2 months)
- Physical activity level(Change from baseline at 2 months)