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

NCT ID: NCT04807153

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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Pneumonectomy is a high risk surgical procedure compared to lobectomy, segmentectomy and non-anatomical resection. Pneumonectomy causes impairment of respiratory functions and exercise intolerance. Assessment of exercise capacity in pneumonectomy is prognostically important. Exercise intolerance can also occur with daily activities using the upper extremity. There is no study investigated upper extremity exercise capacity in this patient population. Postoperative pulmonary functions are determinant for early postoperative results as well as long-term postoperative quality of life. Therefore, it is necessary to evaluate respiratory functions in patients after surgery. Respiratory muscle functions are impaired due to changes in chest wall mechanics and incisions applied to respiratory muscles after surgery. There is no study investigated respiratory muscle endurance in this patient population.

Pneumonectomy is associated with decreased physical activity and quality of life. The number of studies investigating physical activity level in lung cancer patients undergoing pneumonectomy is limited. In this study, physical activity level will be evaluated by metabolic holter. Pneumonectomy has been shown as a predictor of deterioration in quality of life after surgery. In this study, the quality of life will be evaluated using a questionnaire specific to the disease. Fatigue is a common symptom in patients after lung cancer surgery. It negatively affects the patients quality of life and long-term prognosis.

Lung cancer patients undergoing pneumonectomy by the physicians of Gazi University Thoracic Surgery Department and healthy individuals will be included in this study. Patients and healthy individuals will be evaluated and the evaluation results will be compared. According to the sample size analysis 17 patients and 17 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days.

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.

Conditions

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Pneumonectomy; Status

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* willing to participate to the study
* being between ages of 20 and 80

Exclusion Criteria

* 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


* 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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meral BOŞNAK GÜÇLÜ, Prof.Dr.

Role: STUDY_DIRECTOR

Gazi University

Gülsüm SERTTAŞ

Role: STUDY_CHAIR

Gazi University

Nur Dilvin ÖZKAN, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ali ÇELİK, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

İsmail Cüneyt KURUL, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25350720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22172356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29362707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22691825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25262229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40748386 (View on PubMed)

Other Identifiers

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Gazi University 23

Identifier Type: -

Identifier Source: org_study_id

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