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

Overview

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.

Interventions

• Device 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. Pa
• 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.

Primary outcome measures

• Oxygen Consumption [Time frame: Trough study completion, an average of 2 year]
• Muscle oxygenation [Time frame: Trough study completion, an average of 2 year]
• Balance [Time frame: Trough study completion, an average of 2 year]
• Balance (timed up and go test) [Time frame: Trough study completion, an average of 2 year]
• Physical activity level [Time frame: Trough study completion, an average of 2 year]

Secondary outcome measures (12)

• Respiratory Muscle Strength [Time frame: Trough study completion, an average of 2 year]
• Respiratory Muscle Endurance [Time frame: Trough study completion, an average of 2 year]
• Pulmonary function (Forced expiratory volume in the first second (FEV1)) [Time frame: Trough study completion, an average of 2 year]
• Pulmonary function (Forced vital capacity (FVC)) [Time frame: Trough study completion, an average of 2 year]
• Pulmonary function (FEV1/FVC) [Time frame: Trough study completion, an average of 2 year]
• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) [Time frame: Trough study completion, an average of 2 year]
• Pulmonary function (Peak flow rate (PEF)) [Time frame: Trough study completion, an average of 2 year]
• Peripheral Muscle Strength [Time frame: Trough study completion, an average of 2 year]
• Trunk muscle endurance [Time frame: Trough study completion, an average of 2 year]
• Cough Strength [Time frame: Trough study completion, an average of 2 year]
• Dyspnea [Time frame: Trough study completion, an average of 2 year]
• Fatigue [Time frame: Trough study completion, an average of 2 year]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, — Ankara

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06245343 · Gazi University 80

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗