Clinical trial NCT04807153: Exercise Capacity, Pulmonary Function and Physical Activity Level in Patients Lung Cancer Undergoing Pneumonectomy
Official title: Exercise Capacity, Pulmonary Function and Physical Activity Levels in Patients With Lung Cancer Undergoing Pneumonectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonectomy; Status
Keywords: Lung Cancer
Pneumonectomy
Exercise Capacity
Upper Extremity Exercise Capacity
Physical Activity
Pulmonary Function
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria for patients group: Patients who are;

* 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

Exclusion criteria for patients group: Patients who are;

* 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

Inclusion criteria for healthy group: Participants who are;

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

Exclusion criteria for healthy group: Participants who are;

* 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)

Primary outcomes:
measure: Functional Exercise Capacity
timeFrame: First Day
measure: Upper Extremity Exercise Capacity
timeFrame: First Day
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
Secondary outcomes:
measure: Respiratory Muscle Strength
timeFrame: First Day
measure: Peripheral Muscle Strength
timeFrame: Second Day
measure: Respiratory Muscle Endurance
timeFrame: First Day
measure: Physical Activity Level
timeFrame: Second Day
measure: Disease Specific Quality of Life
timeFrame: Second Day
measure: Fatigue
timeFrame: Second Day
measure: Shortness of breath
timeFrame: First Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Gülsüm SERTTAŞ
role: STUDY_CHAIR
affiliation: Gazi University
name: Nur Dilvin ÖZKAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ali ÇELİK, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İsmail Cüneyt KURUL, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.