Early Effects of Different Inspiratory Muscle Training on Disease Clinical Course, Respiratory Parameters, Functional Capacity and Quality of Life in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Dyspnea Assessment
研究概览
简要总结
COPD is one of the most life-threatening pulmonary diseases. According to the World Health Organization, it is expected to rise to the third leading cause of death by 2030. Smoking is the most significant contributing factor. COPD reduces lung volumes and causes dyspnea. Over time, respiratory muscle weakness develops, leading to hypercapnia, dyspnea, nocturnal oxygen desaturation, and decreased exercise performance. Pulmonary rehabilitation is the most important component of COPD treatment. Respiratory muscle training should be a mandatory component of the pulmonary rehabilitation program. Combining inspiratory muscle training with functional exercises allows the focus to be on respiratory muscle functions beyond the task of breathing. The purpose of this study was to investigate the effects of Functional Inspiratory Muscle Training on the course of the disease.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disease with high mortality and morbidity, although it is preventable and treatable. Environmental and genetic factors, primarily smoking, play a role in the development of the disease. The most common symptom in COPD is dyspnea, which is associated with respiratory muscle dysfunction, hyperinflation, and exercise intolerance. Pulmonary rehabilitation, especially exercise training and respiratory muscle training, is a fundamental component of COPD management.
Inspiratory muscle training (IMT) aims to improve dyspnea, exercise capacity, and quality of life by increasing respiratory muscle strength and endurance. In recent years, Functional Inspiratory Muscle Training (F-IMT) has been developed, focusing on the role of respiratory muscles in postural control and trunk stabilization. However, studies on the effects of F-IMT in individuals with COPD are limited.
The aim of our study was to compare the early-term effects of basic IMT and F-IMT on the disease course in individuals with COPD. In this study, we aim to learn which training is more beneficial for individuals with COPD.
Scope: This is a prospective experimental study. The study will be conducted on total 51 individuals who meet the inclusion criteria. The study population will consist of patients admitted to Yalova Training and Research Hospital.
Inclusion Criteria:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a COPD diagnosis according to GOLD criteria Having not had an acute exacerbation within the last month Being able to walk independently Having no communication problems Voluntarily participating in the study
排除标准
- •Being in a COPD exacerbation Having an orthopedic or neurological disease that would prevent assessment and treatment Having uncontrolled hypertension and heart disease
研究组 & 干预措施
Basic Inspiratory Muscle Training
The participant will complete IMT training with a physiotherapist one day a week and without a supervisor for the remaining 6 days, 15 minutes in the morning and 15 minutes in the evening.
干预措施: Basic Inspiratory Muscle Training (Other)
Functional Inspiratory Muscle Training
The participant will follow the same Basic IMT program for the first four weeks, and then perform the specified exercises for the remaining four weeks, 3 days a week, for 30 minutes, under the supervision of a physiotherapist. The remaining four days will include 15-minute Basic IMT training in the morning and evening, without a supervisor.
干预措施: Functional Inspiratory Muscle Training (Other)
Control
Simple upper extremity exercises and diaphragmatic breathing exercises will be given with equipment suitable for the home environment, 1 day a week accompanied by a physiotherapist for 30 minutes, and the remaining 6 days without a supervisor for 15 minutes in the morning and 15 minutes in the evening. (8-12 repetitions, 2 sets, 1-2 minute break)
干预措施: Control (Other)
结局指标
主要结局
Dyspnea Assessment
时间窗: Baseline and through study completion, an average of 8 weeks
Modified Medical Research Council -mMRC: The mMRC used for dyspnea assessment consists of five stages. Stage 0 represents mild dyspnea, and Stage 4 represents severe dyspnea (Bestall et al., 1999).
COPD Assesment Test
时间窗: Baseline and through study completion, an average of 8 weeks
COPD Assessment Test (CAT): The test consists of eight questions that examine cough, phlegm, shortness of breath, home and outdoor difficulties, sleep, and fatigue parameters. The maximum score is 40. As the score increases, symptoms worsen. The validity and reliability of the Turkish version was conducted by Yorgancıoğlu et al. (Yorgancioglu, 2012).
Pulmonary Function Testing
时间窗: Baseline and through study completion, an average of 8 weeks
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. Forced expiratory volume in one second (FEV1) is measured (Miller et al., 2005).
Respiratory Muscle Strength Measurement
时间窗: Baseline and through study completion, an average of 8 weeks
Maximal inspiratory pressure measurements (MIP) will be taken. For the MIP measurement, the participant sits in a chair and, with a nose clip attached, is asked to take a maximum inspiration through the mouth for 1-3 seconds (Neder et al., 1999)..
Exercise Capacity Assessment
时间窗: Baseline and through study completion, an average of 8 weeks
Six-Minute Walk Test - 6MWT: The six-minute walk test is one of the most frequently used field tests in clinical settings due to its practicality and low cost, assessing submaximal functional capacity. The test is conducted in a 30-meter corridor. After being informed about the test, the participant is asked to walk in a marked area in the corridor for six minutes, and the total distance is recorded. It is recommended that it be performed three times at regular intervals throughout the day, and the best distance recorded. The patient may stop and rest at any time and use assistive devices if available. Blood pressure, heart rate, oxygen saturation, fatigue, and dyspnea are measured before and after the test. In individuals with COPD, a walk of \<350 meters is associated with lower exercise capacity and increased mortality risk (Ceylan, 2014). A 6-minute walk will result in a report calculating the total distance walked in meters.
次要结局
- Cognitive Performance(Baseline and through study completion, an average of 8 weeks)
- Peripheral Muscle Strength Measurement(Baseline and through study completion, an average of 8 weeks)
- Balance Assessment (Berg Balance Scale-BDI)(Baseline and through study completion, an average of 8 weeks)
- Core Muscle Assessment(Baseline and through study completion, an average of 8 weeks)
- Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test)(Baseline and through study completion, an average of 8 weeks)
- Depression Assessment (Beck Depression Inventory-BDI)(Baseline and through study completion, an average of 8 weeks)
- Activity of Daily Living Assessment(Baseline and through study completion, an average of 8 weeks)
- Quality of Life Assessment(Baseline and through study completion, an average of 8 weeks)
- Fatigue Assessment(Baseline and through study completion, an average of 8 weeks)
- Physical Activity Level Assessment(Baseline and through study completion, an average of 8 weeks)
研究者
ERDİ KAYABINAR
Assistant Professor
University of Yalova