Exercise Capacity, Pulmonary Function and Physical Activity Level in Patients Lung Cancer Undergoing Pneumonectomy

NCT04807153 | Completed

• 1 other identifier: Gazi University 23
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonectomy is a high-risk surgical procedure, causing impaired respiratory functions and exercise intolerance. It is associated with decreased physical activity, quality of life and increased fatigue. The primary aim of the study is to compare the exercise capacity and respiratory functions of lung cancer patients undergoing pneumonectomy and healthy individuals. The secondary aim of the study is to compare peripheral and respiratory muscle strength, respiratory muscle endurance, physical activity level, shortness of breath, fatigue and quality of life of lung cancer patients undergoing pneumonectomy and healthy individuals.

Conditions

Pneumonectomy; Status

Keywords

Lung Cancer; Pneumonectomy; Exercise Capacity; Upper Extremity Exercise Capacity; Physical Activity; Pulmonary Function

Outcome Measures

Primary Outcomes (7)

• Functional Exercise Capacity

  Functional exercise capacity will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.

  First Day

• Upper Extremity Exercise Capacity

  The functional capacity of the upper extremities will be evaluated with a six-minute pegboard and ring test (6-PBRT). Subjects are asked to move as many rings as possible in 6 minutes. The score is the number of rings moved during the 6-minute period.

  First Day

• Pulmonary function (Forced vital capacity (FVC))

  Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.

  First Day

• Pulmonary function (Forced expiratory volume in the first second (FEV1))

  Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.

  First Day

• Pulmonary function (FEV1 / FVC)

  Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.

  First Day

• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

  Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.

  First Day

• Pulmonary function (Peak flow rate (PEF))

  Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

  First Day

Secondary Outcomes (7)

• Respiratory Muscle Strength

  First Day

• Peripheral Muscle Strength

  Second Day

• Respiratory Muscle Endurance

  First Day

• Physical Activity Level

  Second Day

• Disease Specific Quality of Life

  Second Day

Study Arms (2)

Patients

Functional exercise capacity (6 minutes walk test), upper extremity exercise capacity (6 minutes Pegboard and Ring Test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), respiratory muscle endurance (incremental threshold loading test), physical activity level (multi-sensor activity monitor), quality of life (European Cancer Research and Treatment Organization Quality of Life Scale (EORTC QOL C-30)), fatigue (Fatigue Severity Scale) and shortness of breath (Modified Medical Research Council (MMRC)) will be evaluated.

Healthy Controls

Functional exercise capacity (6 minutes walk test), upper extremity exercise capacity (6 minutes Pegboard and Ring Test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), respiratory muscle endurance (incremental threshold loading test), physical activity level (multi-sensor activity monitor), quality of life (European Cancer Research and Treatment Organization Quality of Life Scale (EORTC QOL C-30)), fatigue (Fatigue Severity Scale) and shortness of breath (Modified Medical Research Council (MMRC)) will be evaluated.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 17 patients with lung cancer patients undergoing pneumonectomy will be included in patients group and 17 healthy individuals will be included in control group

You may qualify if:

• pneumonectomy for lung cancer
• at least 6 weeks and at most 5 years after surgery
• being between ages of 20 and 80
• one of video-assisted thoracoscopic surgery or open thoracic surgery

You may not qualify if:

• having comorbidities such as uncontrolled hypertension, diabetes mellitus, heart failure or atrial fibrillation
• having health problems such as cooperation
• having acute infection during evaluation
• having orthopedic, neurological, psychological, etc. problems that limit evaluations
• willing to participate to the study
• being between ages of 20 and 80
• having any diagnosis of chronic diseases
• having health problems such as cooperation
• having acute infection during evaluation
• being current smokers
• being ex-smokers (≥10 pack\*years)

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)

Location

Related Publications (6)

• Vainshelboim B, Fox BD, Saute M, Sagie A, Yehoshua L, Fuks L, Schneer S, Kramer MR. Limitations in exercise and functional capacity in long-term postpneumonectomy patients. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):56-64. doi: 10.1097/HCR.0000000000000085.

  PMID: 25350720 BACKGROUND

• Deslauriers J, Ugalde P, Miro S, Deslauriers DR, Ferland S, Bergeron S, Lacasse Y, Provencher S. Long-term physiological consequences of pneumonectomy. Semin Thorac Cardiovasc Surg. 2011 Autumn;23(3):196-202. doi: 10.1053/j.semtcvs.2011.10.008.

  PMID: 22172356 BACKGROUND

• Brocki BC, Westerdahl E, Langer D, Souza DSR, Andreasen JJ. Decrease in pulmonary function and oxygenation after lung resection. ERJ Open Res. 2018 Jan 19;4(1):00055-2017. doi: 10.1183/23120541.00055-2017. eCollection 2018 Jan.

  PMID: 29362707 BACKGROUND

• Menna C, Ciccone AM, Ibrahim M, Andreetti C, D'Andrilli A, Maurizi G, Cassiano F, Cavaliere I, Venuta F, Rendina EA. Pneumonectomy: quality of life and long-term results. Minerva Chir. 2012 Jun;67(3):219-26. English, Italian.

  PMID: 22691825 BACKGROUND

• Agostini PJ, Naidu B, Rajesh P, Steyn R, Bishay E, Kalkat M, Singh S. Potentially modifiable factors contribute to limitation in physical activity following thoracotomy and lung resection: a prospective observational study. J Cardiothorac Surg. 2014 Sep 27;9:128. doi: 10.1186/1749-8090-9-128.

  PMID: 25262229 BACKGROUND

• Serttas Guven G, Ozkan Koyuncuoglu ND, Celik A, Kurul IC, Bosnak Guclu M. Upper extremity functional exercise capacity, muscle oxygenation, respiratory muscle strength, and physical activity levels in patients underwent pneumonectomy for lung cancer: a cross-sectional study. Support Care Cancer. 2025 Aug 1;33(8):739. doi: 10.1007/s00520-025-09731-z.

  PMID: 40748386 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Meral BOŞNAK GÜÇLÜ, Prof.Dr.

  Gazi University

  STUDY DIRECTOR

• Gülsüm SERTTAŞ

  Gazi University

  STUDY CHAIR

• Nur Dilvin ÖZKAN, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ali ÇELİK, Assoc. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

• İsmail Cüneyt KURUL, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 19, 2021
• Study Start: March 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)