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Clinical Trials/NCT04807153
NCT04807153
Completed
Not Applicable

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

Gazi University1 site in 1 country34 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonectomy; Status
Sponsor
Gazi University
Enrollment
34
Locations
1
Primary Endpoint
Functional Exercise Capacity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
July 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Functional Exercise Capacity

Time Frame: First Day

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

Upper Extremity Exercise Capacity

Time Frame: First Day

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.

Pulmonary function (Forced vital capacity (FVC))

Time Frame: First Day

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.

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

Time Frame: First Day

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.

Pulmonary function (FEV1 / FVC)

Time Frame: First Day

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.

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

Time Frame: First Day

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.

Pulmonary function (Peak flow rate (PEF))

Time Frame: First Day

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.

Secondary Outcomes

  • Peripheral Muscle Strength(Second Day)
  • Respiratory Muscle Strength(First Day)
  • Respiratory Muscle Endurance(First Day)
  • Physical Activity Level(Second Day)
  • Disease Specific Quality of Life(Second Day)
  • Fatigue(Second Day)
  • Shortness of breath(First Day)

Study Sites (1)

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