Clinical trial NCT06245343: Investigation of the Effects of Functional Inspiratory Muscle Training in Patients With Lung Cancer
Official title: Investigation of the Effects of Functional Inspiratory Muscle Training on Oxygen Consumption, Muscle Oxygenation, Balance and Physical Activity Level in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Oxygen consumption
Muscle oxygenation
Balance
Physical activity
Functional inspiratory muscle training
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-80 years with lung cancer
2. Patients who have undergone surgical treatment (wedge resection, segmentectomy, lobectomy, bilobectomy) for lung cancer
3. Lung cancer treatment completed, in remission and under follow-up

Exclusion Criteria:

1. According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests
2. Patients who are having comorbidities such as uncontrolled hypertension, diabetes mellitus, heart failure or atrial fibrillation
3. Patients who are having acute infection during evaluation
4. Patients who are having orthopedic, neurological, psychological, etc. problems that limit evaluations

Primary outcomes:
measure: Oxygen Consumption
timeFrame: Trough study completion, an average of 2 year
measure: Muscle oxygenation
timeFrame: Trough study completion, an average of 2 year
measure: Balance
timeFrame: Trough study completion, an average of 2 year
measure: Balance (timed up and go test)
timeFrame: Trough study completion, an average of 2 year
measure: Physical activity level
timeFrame: Trough study completion, an average of 2 year
Secondary outcomes:
measure: Respiratory Muscle Strength
timeFrame: Trough study completion, an average of 2 year
measure: Respiratory Muscle Endurance
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (FEV1/FVC)
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: Trough study completion, an average of 2 year
measure: Peripheral Muscle Strength
timeFrame: Trough study completion, an average of 2 year
measure: Trunk muscle endurance
timeFrame: Trough study completion, an average of 2 year
measure: Cough Strength
timeFrame: Trough study completion, an average of 2 year
measure: Dyspnea
timeFrame: Trough study completion, an average of 2 year
measure: Fatigue
timeFrame: Trough study completion, an average of 2 year
measure: Disease Specific Quality of Life
timeFrame: Trough study completion, an average of 2 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Gülsüm SERTTAŞ GÜVEN, MSc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Ece BAYTOK, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Muhammet SAYAN, A. Prof. Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ali ÇELİK, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
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