The Effect of Respiratory Muscle Training on Respiratory Parameters, Functional Capacity, Balance and Quality of Life in Interstitial Lung Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Respiratory Function Test / Forced Vital Capacity (FVC)
研究概览
简要总结
The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.
详细描述
Interstitial lung disease (ILD) include a heterogeneous group of progressive, acute and chronic diseases that diffusely affect the lung and characterized by varying degrees of inflammation and fibrosis in the lung parenchyma. The disease group usually shows a restrictive pattern and progresses with gas exchange abnormalities.
Progressive lung fibrosis was first described in 1935. Over the years, more than 150 lung disease characterized by acute or chronic pulmonary fibrosis of varying degrees with known or unknown cause have been defined and these diseases were named interstitial lung disease (ILD) in 1970s. Common symptoms in chronic interstitial lung diseases in general; dyspnea, dry cough, exercise intolerance and fatigue. All these features of interstitial lung diseases cause an increase in respiratory work and ventilatory deterioration in exercise. Apart from these general features, muscle weakness and related exercise intolerance may occur in some specific conditions.
The most important factor limiting exercise capacity in these patients is circulatory disorder, which cause exercise induced deterioration in gas exchange. Hypoxemia induced exercise intolerance causes a decrease in health-related quality of life, limitation of functional capacity and inactivity in daily life.
According to the American Thoracic Society (ATS) / European Respiratory Society (ERS) respiratory rehabilitation guideline, although the data are not conclusive, inspiratory muscle training is recommended as an adjunct to pulmonary rehabilitation, especially in patients with suspected or confirmed respiratory muscle weakness. The effect of well-structured and supervised inspiratory muscle training (IMT) on respiratory functions, diaphragm weakness, functional capacity, balance and quality of life in patients with interstitial lung disease is unknown.
It is important that this research will be carried out in this area and because it has a current subject.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.),
- •Being clinically stable,
- •Not receiving supplemental oxygen therapy,
- •No pulmonary infection in the last 6 weeks,
- •Being ambulation.
排除标准
- •Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis
- •Presence of a history of effort-induced syncope
- •Presence of severe orthopedic or neurological disease
- •Presence of unstable serious cardiac disease
研究组 & 干预措施
Control Group
Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased.
干预措施: Conventional Chest Physiotherapy (Other)
Inspiratory Muscle Training (IMT) Group
In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value.
干预措施: Conventional Chest Physiotherapy (Other)
Inspiratory Muscle Training (IMT) Group
In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value.
干预措施: Inspiratory Muscle Training (Other)
结局指标
主要结局
Respiratory Function Test / Forced Vital Capacity (FVC)
时间窗: Eight weeks
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
时间窗: Eight weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Balance / Limits of Stability
时间窗: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Balance / Sensory Integration and Balance Test Score
时间窗: Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Respiratory Function Test / Peak Expiratory Flow (PEF)
时间窗: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
时间窗: Eight weeks
Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
时间窗: Eight weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
时间窗: Eight weeks
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Functional Capacity
时间窗: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Balance / Postural Stability
时间窗: Eight weeks
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
次要结局
- Dyspnea(Eight weeks)
- Health-Related Quality of Life(Eight weeks)
- Peripheral Muscle Strength(Eight weeks)
- Pain Level(Eight weeks)
研究者
Onur Aydın
Lecturer, PT, PhD (c)
Bezmialem Vakif University