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

NCT06245343 | Recruiting

• 1 other identifier: Gazi University 80
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Oxygen consumption; Muscle oxygenation; Balance; Physical activity; Functional inspiratory muscle training

Outcome Measures

Primary Outcomes (5)

• Oxygen Consumption

  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.

  Trough study completion, an average of 2 year

• Muscle oxygenation

  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.

  Trough study completion, an average of 2 year

• Balance

  Balance will be evaluated using a balance assessment device.

  Trough study completion, an average of 2 year

• Balance (timed up and go test)

  Balance will be evaluated a timed up and go test.

  Trough study completion, an average of 2 year

• Physical activity level

  A multi-sensor activity monitor will be used to assess the level of physical activity.

  Trough study completion, an average of 2 year

Secondary Outcomes (13)

• Respiratory Muscle Strength

  Trough study completion, an average of 2 year

• Respiratory Muscle Endurance

  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 (Forced vital capacity (FVC))

  Trough study completion, an average of 2 year

• Pulmonary function (FEV1/FVC)

  Trough study completion, an average of 2 year

Study Arms (2)

Functional inspiratory muscle training group

EXPERIMENTAL

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.

Device: Functional inspiratory muscle training group

Control group

SHAM COMPARATOR

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

Device: Control group

Interventions

Functional inspiratory muscle training group 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.

Functional inspiratory muscle training group

Control group 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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Cooley ME. Symptoms in adults with lung cancer. A systematic research review. J Pain Symptom Manage. 2000 Feb;19(2):137-53. doi: 10.1016/s0885-3924(99)00150-5.

  PMID: 10699541 BACKGROUND

• 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.

  PMID: 20619225 BACKGROUND

• 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.

  PMID: 8737692 BACKGROUND

• 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.

  PMID: 24360323 BACKGROUND

• 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.

  PMID: 36044444 BACKGROUND

• 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.

  PMID: 34417883 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gülsüm SERTTAŞ GÜVEN, MSc.

  Gazi University

  STUDY CHAIR

• Ece BAYTOK, MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Muhammet SAYAN, A. Prof. Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ali ÇELİK, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Gülsüm SERTTAŞ GÜVEN, MSc.

CONTACT

glsmserttas1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof. Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 7, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)