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

NCT ID: NCT06245343

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2026-12-15

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional inspiratory muscle training group

Intervention Type: DEVICE

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.

Control group

The control group will not be given any training during the study period.

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: DEVICE

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.

Interventions

Functional inspiratory muscle training group

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.

Intervention Type: DEVICE

Control group

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Study director, PT, PhD, Prof. Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülsüm SERTTAŞ GÜVEN, MSc.

Role: STUDY_CHAIR

Gazi University

Ece BAYTOK, MSc.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Muhammet SAYAN, A. Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ali ÇELİK, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: CONTACT

meralbosnak@gazi.edu.tr

+903122162647

Gülsüm SERTTAŞ GÜVEN, MSc.

Role: CONTACT

glsmserttas1@gmail.com

Facility Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: primary

meralbosnak@gazi.edu.tr

0312 216 2647

References

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Reference Type: BACKGROUND

PMID: 10699541 (View on PubMed)

Miserocchi G, Beretta E, Rivolta I. Respiratory mechanics and fluid dynamics after lung resection surgery. Thorac Surg Clin. 2010 Aug;20(3):345-57. doi: 10.1016/j.thorsurg.2010.03.001.

Reference Type: BACKGROUND

PMID: 20619225 (View on PubMed)

Nomori H, Horio H, Fuyuno G, Kobayashi R, Yashima H. Respiratory muscle strength after lung resection with special reference to age and procedures of thoracotomy. Eur J Cardiothorac Surg. 1996;10(5):352-8. doi: 10.1016/s1010-7940(96)80094-7.

Reference Type: BACKGROUND

PMID: 8737692 (View on PubMed)

Granger CL, McDonald CF, Irving L, Clark RA, Gough K, Murnane A, Mileshkin L, Krishnasamy M, Denehy L. Low physical activity levels and functional decline in individuals with lung cancer. Lung Cancer. 2014 Feb;83(2):292-9. doi: 10.1016/j.lungcan.2013.11.014. Epub 2013 Nov 26.

Reference Type: BACKGROUND

PMID: 24360323 (View on PubMed)

Kocjan J, Gzik-Zroska B, Nowakowska-Lipiec K, Burkacki M, Suchon S, Michnik R, Czyzewski D, Adamek M. Thoracic surgery may alter body static balance via diaphragm dysfunction. PLoS One. 2022 Aug 31;17(8):e0273641. doi: 10.1371/journal.pone.0273641. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36044444 (View on PubMed)

de Oliveira Vacchi C, Martha BA, Macagnan FE. Effect of inspiratory muscle training associated or not to physical rehabilitation in preoperative anatomic pulmonary resection: a systematic review and meta-analysis. Support Care Cancer. 2022 Feb;30(2):1079-1092. doi: 10.1007/s00520-021-06467-4. Epub 2021 Aug 21.

Reference Type: BACKGROUND

PMID: 34417883 (View on PubMed)

Other Identifiers

Gazi University 80

Identifier Type: -

Identifier Source: org_study_id