Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Respiratory muscle strength
研究概览
简要总结
Interstitial lung disease (ILD) is a diverse group of parenchymal lung disorders characterized by restrictive lung function and impaired alveolar diffusion capacity, leading to dyspnea on exertion, reduced exercise endurance, and poor quality of life. Patients usually complain of progressive breathlessness, persisting non-productive cough, which occurs with exercise. Hemoptysis, fever, chest pain are also seen. The most common comorbidity in chronic lung diseases is the progressive loss of exercise tolerance. Not only dyspnea, but also peripheral muscle dysfunction and cognitive deficits such as, anxiety and depression are responsible for the reduction of mobility in the patient. In the context of pulmonary rehabilitation (PR) program to be applied in interstitial lung diseases; upper and lower limb endurance, stretching and relaxation techniques, aerobic exercise training, respiratory muscle training, training of energy conservation methods, support by determining oxygen requirement, nutritional evaluation, prevention of weight and muscle loss, psycho-social support. The purpose of PR programs in this disease is; to improve muscle strength, endurance, and mechanical activity, to improve dyspnea sensation, to improve functional capacity, to inform and educate the patient about the patient's disease. The use of whole body vibration (TVT) is an increasingly common method of therapeutic use in order to improve neuromuscular performance. TVT applications have shown that increases muscle activity, muscle strength and muscle strength, improves lower extremity blood circulation and balance, and increases growth hormone production. TVT training effects have rarely been studied in patients with pulmonary disease. Muscle strength and performance enhancement were significant effects of TVT, which was emphasized as a promising exercise method for those with chronic obstructive pulmonary disease (COPD). Over the past decade, endurance and strength training has been established as the most important components of exercise training programs in patients with COPD and ILD. Therefore, inclusion of TVT into exercise training programs in ILD patients may lead to beneficial results.
The investigators hypotheses are:
- the combination of home respiratory exercises with whole body vibration training may lead to more improved respiratory muscle strength, dyspnoea, functional capacity, balance, peripheral muscle strength and quality of life in ILD patients
- when applied as an isolated intervention, home respiratory exercises programme may lead to lower results than combination programs.
详细描述
Patients:
All participants with ILD will be recruited from a Cerrahpasa Medical Faculty Hospital between January 2017 and June 2018. All treatments will performed in the same hospital.
Sample Size:
"Power and Sample Size Program" was used to calculate sample size. Power analysis was done with Pass 11 Home program. In the power analysis program, α = 0,05, β = 0,15 1- β = 0,84. When the number of samples of the groups was 30 and 30, 84% power was obtained. Using a two-sided two-sample t-test, the standard deviations from the 0,05 alpha value are 7.0 and 6.0.
Procedure:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with interstitial lung disease (Idiopathic Pulmonary Fibrosis, pneumoconiosis, chronic hypersensitivity pneumonia, radiation fibrosis, collagenosis pulmonary involvement, nonspecific interstitial pneumonitis-NSIP, idiopathic NSIP)
- •Patients whose stability and medical treatment have not been changed for the last 3 months will be included in the study.
排除标准
- •Malignant tumor,
- •presence of co-morbidities that prevent exercise training (severe orthopedic or neurological deficit, unstable cardiac disease)
- •The knee and / or hip joint replacement operation has been performed,
- •having lower and upper limb amputation,
- •taking any hormone replacement or medication that may affect the normal metabolism of the musculoskeletal system,
- •presence of neurological (MS, intracranial tumor, neurodegenerative diseases, cerebrovascular event, epilepsy) disease which will affect balance and proprioception,
- •those with drug use history (antidepressants, anticonvulsants, sedatives, betahistine) that may affect the balance,
- •having Ischemic heart disease, dilate, hypertrophic or nonidiopathic cardiomyopathy,
- •having pacemaker entity, By-pass, coronary stent,
- •having uncontrolled DM,
- •presence of acute arthritis / tendinopathy,
- •O2 saturation in room air <80% (resting), patient with advanced respiratory failure,
- •having severe neurological and / or metabolic pathologies,
- •having hemodynamic instability,
- •Being pregnant and breastfeeding,
- •Individuals with a recent surgical operation, ILD, will not be included in the study.
结局指标
主要结局
Respiratory muscle strength
时间窗: 4 weeks
Respiratory muscle strength will be measured using a portable electronic mouth measuring instrument (MicroRPM; Micro Medical, UK). Maximum inspiratory (MIP) and expiratory (MEP) pressures are noninvasive tests that indirectly indicate respiratory muscle strength. It is the intraoral pressure measured during maximal inspiration and maximal respiration against a valve (shutter) that closes the respiratory tract during expiration. The best of three measurements is accepted.
Diffusing capacity for carbon monoxide (DLCO)
时间窗: 4 weeks
The single breath carbon monoxide diffusion test method will be used to calculate the diffusion capacity. Carbonmonoxide Diffusion (DLCO) measurement is an important noninvasive test that provides information on pulmonary gas exchange. The CO concentrations are measured by passing the analyzer through a breathing air analyzer of the patient, which is then exhaled into the device; the amount of CO transferred to the blood is calculated from the difference between the inspired air and the CO concentrations in the expired air.
Pulmonary Function Test
时间窗: 4 weeks
The pulmonary function test (PFT) will be performed with a portable spirometry device (Spirobank II) with the nose closed and at least three times in the sitting position. After the nose is tightened with a latch, the person breathes normally on the spirometer. After a few normal inspirations and expirations, it is desirable to take a deep breath at the end of the expiration at the level of rest, and to release the air slowly and continuously afterwards. With this application, the volumes and capacities outside the residual volume (RV), functional residual capacity (FRC) and total lung capacity (TLC) are calculated.
6-minute pegboard and ring test (6PBRT)
时间窗: 4 weeks
Subjects are asked to sit straight in a chair and a pegboard with multiple peg positions is placed in front of the subject at arm's length from the body. Two pegs are positioned at the shoulder level and 2 at 20 cm above the shoulder level, and 10 rings (1/2 oz per ring) are put on each of the 2 lower pegs. The final score is the total number of rings moved during the 6-minute period. Subjects are permitted to stop and rest during the test if they feel severe dyspnea, fatigue, or other discomfort, and continue moving the pegs as soon as they can. Subjects are asked to score the perceived dyspnea and fatigue after the test by the Borg scale. Each subject performe the PBRT twice. A pulse oximeter is used to monitor heart rate (HR) and arterial oxygen saturation (Sao2), and measure blood pressure (BP) before and after each test.
6-minute walk test (6MWT)
时间窗: 4 weeks
Functional exercise capacity was assessed using the 6-minute walk test (6MWT). Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and pulse oximeter will measure O2 saturation, and according to Borg scale, dyspnea and fatigue level will be determined. Oxygen will be provided immediately following exercise for patients who desaturate (SpO2 \<88%), or as needed.
次要结局
- Sit to Stand Test (STS)(4 weeks)
- The Fatigue Severity Scale (FSS)(4 weeks)
- Timed Up and Go Test (TUG)(4 weeks)
- St. George's Respiratory Questionnaire (SGRQ)(4 weeks)
- Static Posturography System (TETRAX)(4 weeks)
- Peripheral Muscle Strength Measurement(4 weeks)
研究者
Nur Selin Of
Principal Investigator
Istanbul University