Investigation of the Effects of Functional Inspiratory Muscle Training on Oxygen Consumption, Muscle Oxygenation, Balance and Physical Activity Level in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Balance
研究概览
简要总结
Patients' pulmonary functions and diffusion capacity worsen following lung cancer surgery. Diaphragmatic activity and lung compliance decrease due to surgery. Peripheral and respiratory muscle functions are impaired in patients with lung cancer, exercise capacity and physical activity level decreased. Patients have postural instability and balance problems. Inspiratory muscle training has increased inspiratory muscle strength in patients with lung cancer. However, there is no study investigating functional inspiratory muscle training in patients with lung cancer.
详细描述
Lung cancer is a malignant lung tumor characterized by uncontrolled cell growth in lung tissues. The main treatment methods for lung cancer are chemotherapy, radiotherapy, and surgery. Molecularly targeted therapy and immunotherapy are also among the treatment options. Patients with lung cancer experience various symptoms such as dyspnea, cough, chest pain, hemoptysis, fatigue, weight loss due to the disease process, the effects of chemotherapy and radiotherapy treatment, and comorbidities. The treatment method varies depending on the histological type, stage, location of the tumor, and the physical condition of the patient. Surgery is performed as a therapeutic option for many patients with lung cancer. Lung cancer surgery impair the cardiorespiratory functions of the patients. Patients' pulmonary functions and diffusion capacity worsen following lung cancer surgery. In lung cancer patients, the incision applied to the respiratory muscles due to surgery and changes in the mechanics of the chest wall cause worsening of respiratory muscle function. The condition results in dyspnea in patients at rest and during activities of daily living. Mitochondrial dysfunction due to the pathogenesis of the disease and chemotherapy/radiotherapy leads to deterioration in muscle oxygen metabolism. In individuals with reduced muscle oxygen, exercise tolerance and muscle strength decrease. Impairment of diaphragm function is associated with decreased postural stability after lung cancer surgery. Patients with lung cancer have postural instability and balance problems. Lung cancer significantly affects the quality of life of patients, limiting their physical and social activities. Inspiratory muscle training is recommended as part of disease management for lung cancer. In the literature, there are studies investigating the effectiveness of inspiratory muscle training in lung cancer patients in the preoperative, perioperative, and postoperative periods. However, there is no study investigating functional inspiratory muscle training in patients with lung cancer. Functional inspiratory muscle training (IMT) was developed by McConnell. It is a program that is based on the functions of respiratory muscles other than breathing, and IMT is applied along with exercise.
The primary aim of this study: To investigate the effects of functional inspiratory muscle training on oxygen consumption, muscle oxygenation, balance and physical activity level in patients with lung cancer.
The secondary aim of this study: To investigate the effects of functional inspiratory muscle training on pulmonary functions, peripheral and respiratory muscle strength, inspiratory and trunk muscle endurance, cough strength, fatigue, dyspnea and quality of life in patients with lung cancer.
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 training group or control group and they will be evaluated and trained at different places and times.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years with lung cancer
- •Patients who have undergone surgical treatment (wedge resection, segmentectomy, lobectomy, bilobectomy) for lung cancer
- •Lung cancer treatment completed, in remission and under follow-up
排除标准
- •According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests
- •Patients who are having comorbidities such as uncontrolled hypertension, diabetes mellitus, heart failure or atrial fibrillation
- •Patients who are having acute infection during evaluation
- •Patients who are having orthopedic, neurological, psychological, etc. problems that limit evaluations
研究组 & 干预措施
Control group
The control group will not be given any training during the study period.
干预措施: Control group (Device)
Functional inspiratory muscle training group
Patients in the training group will be performed functional inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure.
干预措施: Functional inspiratory muscle training group (Device)
结局指标
主要结局
Balance
时间窗: Trough study completion, an average of 2 year
Balance will be evaluated using a balance assessment device.
Balance (timed up and go test)
时间窗: Trough study completion, an average of 2 year
Balance will be evaluated a timed up and go test.
Oxygen Consumption
时间窗: Trough study completion, an average of 2 year
Maximum exercise capacity will be assessed by symptom-limited cardiopulmonary exercise testing on a treadmill at gradually increasing speed and degree, and oxygen consumption will be measured during the test.
Muscle oxygenation
时间窗: Trough study completion, an average of 2 year
Muscle oxygenation of the quadriceps femoris (during the exercise test) and the diaphragm, scalene muscles, sternocleidomastoid muscle, and rectus abdominis muscle (at rest) will be assessed with a muscle oxygen monitor.
Physical activity level
时间窗: Trough study completion, an average of 2 year
A multi-sensor activity monitor will be used to assess the level of physical activity.
次要结局
- Pulmonary function (Forced vital capacity (FVC))(Trough study completion, an average of 2 year)
- Dyspnea(Trough study completion, an average of 2 year)
- Respiratory Muscle Strength(Trough study completion, an average of 2 year)
- Respiratory Muscle Endurance(Trough study completion, an average of 2 year)
- Peripheral Muscle Strength(Trough study completion, an average of 2 year)
- Trunk muscle endurance(Trough study completion, an average of 2 year)
- Disease Specific Quality of Life(Trough study completion, an average of 2 year)
- Pulmonary function (Forced expiratory volume in the first second (FEV1))(Trough study completion, an average of 2 year)
- Pulmonary function (FEV1/FVC)(Trough study completion, an average of 2 year)
- Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(Trough study completion, an average of 2 year)
- Fatigue(Trough study completion, an average of 2 year)
- Pulmonary function (Peak flow rate (PEF))(Trough study completion, an average of 2 year)
- Cough Strength(Trough 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 Cardiopulmonary Physiotherapy and Rehabilitation
Gazi University