Investigation of the Effects of Upper Extremity Aerobic Exercise Training on Oxygen Consumption, Muscle Oxygenation and Physical Activity in Patients With Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Muscle oxygenation
研究概览
简要总结
Severe dyspnea, cough, fatigue, restrictive type ventilation disorder, decreased pulmonary function, impaired gas exchange, decreased cardiovascular function and exercise intolerance are frequently encountered findings in patients with interstitial lung disease. It was demonstrated exercise training has beneficial effects in patients with interstitial lung disease. However, no study investigated the effects of upper extremity aerobic exercise training on outcomes in patients with interstitial lung disease.
详细描述
Interstitial lung diseases (ILD) are a heterogeneous group of diseases that cause significant mortality and morbidity worldwide. As a result of the chronic inflammatory process in this disease, structural and mechanical pulmonary disorders develop, which are considered the main causes of deterioration in cardiopulmonary functions. Interstitial lung patients have a decrease in both static and dynamic lung volumes and carbon monoxide diffusing capacity (DLCO). As a result of this pathological mechanism, effort dyspnea and an increase in exercise intolerance occur. Therefore, individuals with ILD tend to avoid activities that increase shortness of breath, resulting in decreased physical activity levels and an increased sedentary lifestyle. Individuals whose functional exercise capacities are also limited due to this vicious circle become more dependent in their daily living activities. In addition, peripheral muscle dysfunction is another important factor that causes exercise intolerance in individuals with all chronic lung diseases, including ILD. One of the most important mechanisms triggering peripheral muscle dysfunction in ILD is hypoxia which develops with desaturation. Hypoxia, which causes an increase in oxidative stress, is one of the factors that can cause muscle dysfunction. It has been reported that upper extremity exercise capacity and functional performance are low in individuals with advanced ILD, and it has been stated that upper extremity exercise training may be beneficial in these patients.
However, the effects of upper extremity aerobic exercise training have not been investigated in the literature in patients with ILD. In this context, the primary aim of our study is to investigate the effects of upper extremity interval aerobic exercise training applied to patients with ILD on oxygen consumption, muscle oxygenation, and physical activity level. The secondary aim of the study is to determine the effects of this training on upper extremity functional exercise capacity, respiratory functions, pulmonary diffusion capacity, respiratory and peripheral muscle strength, inspiratory muscle endurance, dyspnea, fatigue, quality of life, sleep quality, anxiety, and depression. For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 21 patients with a diagnosis of ILD will be included in the training and control groups.
The training group will be given upper extremity interval aerobic exercise training with arm ergometer for 30-45 minutes 3 days a week for 6 weeks, and the control group will not be given any training during the study. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.
All assessments will be completed in two days, before and after six weeks of training.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times.
Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
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
- •Diagnosed with ILD according to ATS/ERS criteria,
- •Aged between 18-75 years,
- •No pulmonary infection during the last month,
- •Patients who volunteer to participate in the study
排除标准
- •Patients with,
- •Body mass index >35 kg/m2,
- •An acute pulmonary exacerbation within the last 4 weeks, have an acute upper or lower respiratory tract infection,
- •Presence of obstructive pulmonary disease,
- •Serious neurological, neuromuscular, orthopedic, or other diseases affecting physical functions,
- •Participated in a planned exercise program within the last three months,
- •Cognitive impairment that causes them to have difficulty understanding and following exercise test instructions,
- •Contraindications for exercise testing and/or exercise training according to the American College of Sports Medicine
- •Cancer, renal or hepatic diseases,
- •Aortic stenosis, complex arrhythmia, with aortic aneurysm,
- •Uncontrolled hypertension, diabetes mellitus, heart failure, arrhythmia and serious cardiovascular disease
研究组 & 干预措施
Training Group
The training group will receive upper extremity high-intensity interval aerobic exercise training on an arm ergometer accompanied by a physiotherapist for 6 weeks.
干预措施: Upper extremity high-intensity interval aerobic exercise training (Other)
Control Group
The control group will not be given any training for 6 weeks during the study period.
干预措施: Control Group (Other)
结局指标
主要结局
Muscle oxygenation
时间窗: through study completion, an average of 2 year
Before the cardiopulmonary exercise test and the 6-minute pegboard and ring test (6-PBRT), during and after the tests the muscle oxygenation will be measured by using a near-infrared spectroscopy device. Oxygenation of the quadriceps muscle during the cardiopulmonary exercise test, and deltoid muscle during the 6-PBRT will be evaluated. For this purpose, the sensor will be placed at the midpoint of the dominant side muscles.
Oxygen consumption
时间窗: through study completion, an average of 2 year
Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.
Physical activity level
时间窗: through study completion, an average of 2 year
Physical activity level will be evaluated with a multi-sensor activity device. Multisensor metabolic holter device by detecting the three-dimensional movements of patients; It provides data on total energy expenditure (joules/day), active energy expenditure (joules/day), physical activity duration (min/day), average MET (MET/day), number of steps (steps/day), time spent lying down (min/day). The device will be attached to the non-dominant arms of the patients, and they will be told to wear it for 5 consecutive days, remove the device only during the bath, and reinsert it in the same area after the bath. The average of the parameters of the current four days will be taken and analyzed with the "BodyMedia SenseWear® 7.0 Software" program using the age, gender, body weight and height information of the patients.
次要结局
- Peripheral muscle strength(through study completion, an average of 2 year)
- Respiratory muscle strength(through study completion, an average of 2 year)
- Forced mid-expiratory flow rate (FEF25-75%)(through study completion, an average of 2 year)
- Diffusion capacity for carbon monoxide (DLCO)(through study completion, an average of 2 year)
- Dyspnea perception(through study completion, an average of 2 year)
- Fatigue(through study completion, an average of 2 year)
- Forced expiratory volume exhaled in the first second (FEV1)(through study completion, an average of 2 year)
- FEV1/FVC ratio(through study completion, an average of 2 year)
- Upper extremity functional exercise capacity(through study completion, an average of 2 year)
- Life Quality(through study completion, an average of 2 year)
- Sleep Quality(through study completion, an average of 2 year)
- Anxiety and Depression(through study completion, an average of 2 year)
- Modified Borg scale(through study completion, an average of 2 year)
- Energy expenditure(through study completion, an average of 2 year)
- Inspiratory muscle endurance(through study completion, an average of 2 year)
- Forced vital capacity (FVC)(through study completion, an average of 2 year)
- Peak expiratory flow (PEF)(through study completion, an average of 2 year)
- Carbon monoxide transfer coefficient (KCO=DLCO/Va)(through study completion, an average of 2 year)
- Alveolar ventilation (Va)(through study completion, an average of 2 year)
研究者
Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Gazi University