Investigation of the Effects of Functional Inspiratory Muscle Training in Patients With Lung Cancer

Trial Title: Investigation of the Effects of Functional Inspiratory Muscle Training in Patients With Lung Cancer

NCT ID: NCT06245343

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Respiratory Aspiration

Conditions: Keywords:
Lung cancer
Oxygen consumption
Muscle oxygenation
Balance
Physical activity
Functional inspiratory muscle training

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Device
Intervention name: Functional inspiratory muscle training group
Description: Patients will be given fundamental inspiratory muscle training with the inspiratory muscle training device at 50% of the maximal inspiratory pressure 30 min/day, 3 days/week for 4 weeks online with a physiotherapist. On the other days of the week, the training will be used as a home program. In the 5th week, the functional inspiratory muscle training program will be started. Before the program begins, patients will be shown the exercises in the functional inspiratory muscle training program. Patients will be given functional inspiratory muscle training with the inspiratory muscle training device at 50% of the maximal inspiratory pressure 30 min/day, 3 days/week for 4 weeks online with a physiotherapist. On the other days of the week, fundamental inspiratory muscle training will be used as a home program. Pressure increases will be made weekly to 10 centimeters of water (cmH2O). Unsupervised training sessions will be followed by charts filled out by patients.
Arm group label: Functional inspiratory muscle training group

Intervention type: Device
Intervention name: Control group
Description: The control group will not be given any training during the 8-week period. 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.
Arm group label: Control group

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Address:
City: Ankara
Zip: 06490
Country: Turkey

Status: Recruiting

Contact:
Last name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Phone: 0312 216 2647
Email: meralbosnak@gazi.edu.tr

Start date: May 15, 2024

Completion date: February 15, 2026

Lead sponsor:
Agency: Gazi University
Agency class: Other

Source: Gazi University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06245343