Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation (NMES) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume 1 second (FEV1)
研究概览
简要总结
Interstitial lung disease (ILD) refers to various diseases that occur idiopathic or secondary to some causes, commonly affecting the lung parenchyma, and present with varying degrees of inflammation and fibrosis. Idiopathic pulmonary fibrosis (IPF) progressing with progressive shortness of breath causes a decrease in exercise capacity and quality of life, restrictive changes in pulmonary function tests and a decrease in diffusion capacity. It has been reported that core stabilization exercises improve respiratory function, respiratory muscle strength and functional capacity in healthy individuals and some disease groups. It has also been reported that neuromuscular electrical stimulation (NMES) applied to lower extremity, upper extremity and back or quadriceps muscles reduces dynamic hyperinflation and dyspnea during exercise and increases exercise capacity in COPD patients.No studies have been performed using core stabilization exercises and NMES in IPF patients. It can be assumed that this therapeutic intervention may also be useful in IPF.
Our study was planned to investigate the efficacy of core stabilization exercises and NMES in patients with IPF.
详细描述
Stable idiopathic pulmonary fibrosis will be included in the study from the Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital. Patients will be randomized into 2 groups; Neuromuscular Electrical Stimulation (NMES) and Core Stabilization Exercises Training Group (n: 18): 2 days per week for 6 weeks duration. The demographic measurements, respiratory function test, respiratory muscle strength, dyspnea, 6 minutes walking test, quality of life, depression and clinical characteristics and physical fitness of the patients will be recorded. The following parameters will be evaluated before and after the training of the patients in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Clinically stable
- •Having no infection or exacerbation in the last 3 months
- •Having no uncontrolled cardiological, psychological problems
- •Having no neoplasm, sarcoidosis or collagen vascular diseases
- •Having no neurological, inner ear or orthopedic disease
- •Patients who volunteered to study
排除标准
- •Over 75 years,
- •Chronic obstructive pulmonary disease (COPD)
- •Acute coronary artery disease,
- •Collagen vascular disease,
- •Pneumoconiosis,
- •Sarcoidosis,
- •Non-parenchymal restrictive lung disease and other serious comorbid conditions,
- •Oxygen saturation in room air at rest <80%
- •During acute exacerbation,
- •Echocardiography RVSP> 50 mmHg
- •Patients taking more than 20mg corticosteroid per day
- •Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)
结局指标
主要结局
Forced Expiratory Volume 1 second (FEV1)
时间窗: Baseline and 6 weeks
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function . FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
时间窗: Baseline and 6 weeks
Change from baseline FEV1 / FVC in respiratory function test at 6 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Forced Expiratory flow from between 25% to 75% of Vital Capacity (FEF 25-75)
时间窗: Baseline and 6 weeks
Forced expiratory flow at 25-75% of FVC \[FEF25-75\] (L/sec) was measured with lung spirometry as it was described for FVC, FEV1, FEV1 / FVC measurements.
Peak flow rate (PEF)
时间窗: Baseline and 6 weeks
Change from baseline Peak flow rate (PEF) in respiratory function test at 6 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Functional capacity
时间窗: Baseline and 6 weeks
Change from baseline functional capacity test at 6 weeks. Functional capacity will be assessed by the 6 minute walking test. The test will be performed according to American Thoracic Society (ATS) criteria. Patients will be allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception will be recorded before and after the test. Walking distance will be calculated.
Forced Vital Capacity (FVC)
时间窗: Baseline and 6 weeks
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 6 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Single-breath Diffusing Capacity for Carbon Monoxide (DLCO)
时间窗: Baseline and 6 weeks
The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.
次要结局
- Physical Activity(Baseline and 6 weeks)
- Change from baseline quality of life: Hospital Anxiety and Depression Scale (HADS)(Baseline and 6 weeks)
- The Fatigue Severity Scale(Baseline and 6 weeks)
- Maximum Inspiratory Pressure (MIP)(Baseline and 6 weeks)
- Timed up and go test(Baseline and 6 weeks)
- Maximum Expiratory Pressure (MEP)(Baseline and 6 weeks)
- Change from baseline quality of life: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)(Baseline and 6 weeks)
研究者
ELÇİN ÇAKIR
MSc student
Istanbul University - Cerrahpasa (IUC)