Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Patients with pulmonary nodule scheduled VATS were included in this study. Inclusion and exclusion criteria were considered.

Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery.

Patients with pulmonary nodule scheduled thoracotomy were included in this study. Inclusion and exclusion criteria were considered.

Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery.

Video-assisted thoracoscopic surgery is a minimal invasive technique in which used to diagnose or treat for lung diseases. During this surgery, one or two small incisions are opened via camera and surgical instruments in patient's chest wall. Thus, less muscle and nerve tissue are damaged.

Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.

VATS

Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.

Thoracotomy

Ece BAYTOK, MsC.

Zeliha ÇELİK, MsC.

Merve ŞATIR TÜRK, MD.

Ali ÇELİK, Assoc. Prof.

İsmail Cüneyt KURUL, Prof. Dr.

Meral Boşnak GÜÇLÜ, Prof. Dr.

The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.

According to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. Surgery is the primary treatment approach, especially in early stages lung cancer. Cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. Pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. VATS and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. There are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. And also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously.

According to sample size calculation, at least 15 patients with pulmonary lesion both VATS and thoracotomy groups would be included in the study. The demographic, physical and physiological characteristics were recorded from the patient files. Pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. Primary outcomes were pulmonary function, functional exercise capacity and physical activity level. Secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.

Effects of Surgery Types in Patients With Pulmonary Nodules

Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules

Forced expiratory volume in one second was evaluated with spirometry according American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The value was represented as percentages.

Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.

Forced expiratory volume in one second/Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.

Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.

Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.

6-minute walk test were used to assess functional exercise capacity according to the guidelines. The test was repeated twice in the same day with 30 min interval. The highest distance was recorded for analysis.

6-minute stepper test were used to assess functional exercise capacity according to the guidelines. The height of the stepper used for test was 20 cm. A cycle of up and down was define as one step. The number of steps was recorded for analysis.

Total energy expenditure (joules/day), active energy expenditure (\>3.0 metabolic equivalents (METs)) (joules/day), physical activity duration (\>3.0 METs) (min/day), average MET (METs/day), number of steps (steps/day), lying down (min/day) and sleeping duration (min/day) were measured to interpret the physical activity level of the patients via metabolic holter device. The metabolic holter was worn over triceps brachii muscle of non-dominant extremity for two consecutive days. The patients' activity level were categorized according to number of steps and average MET sums.

Maximal inspiratory pressure (MIP) was performed to evaluate respiratory muscle strength. Evaluation was done by using portable mouth pressure device accordance with the guidelines. The MIP was measured at residual volume after maximal expiration. The measurements were repeated at least seven times for technically acceptable value.

Maximal expiratory pressure (MEP) was performed to evaluate respiratory muscle strength. Evaluation was done by using portable mouth pressure device accordance with the guidelines. The MEP was measured from total lung capacity after maximal inspiration. The measurements were repeated at least seven times for technically acceptable value.

Shoulder abduction, shoulder flexion, elbow extension, quadriceps femoris muscle strength and hand grip strength were evaluated using a hand held dynamometer. The measurements of each muscle were repeated bilaterally three times.

Inspiratory muscle endurance test were performed using respiratory muscle trainer (POWERbreathe) according to incremental threshold loading test protocol. The endurance test was started at thirty percentage of MIP and each two minutes the load of test was increased by ten percentage of MIP. The highest percentage of MIP could be reached and sustained for at least 1 min was defined as maximal load and time were recorded for analysis.

This scale was used to evaluate dyspnea and fatigue perception during 6-minute walk test and 6-minute stepper test. It was scored between 0 and 10. The lowest value was 0 which was meant no dyspnea or fatigue and the highest value was 10 which was meant worse and severe dyspnea and fatigue.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (Turkish version of scale) were used. The questionnaire comprise of 30 items in which five scales and several single items are graded from 1 (not at all) to 4 (very much) except for 29-30 items. All scales and items' scores are expressed by transforming to a 0-100 scale. Higher values except symptom scale represent higher quality of life. The minimum value was '0' and the maximum value was '100'. The highest value was meant better quality of life. The highest value for symptom scale was meant worse symptom.

Fatigue severity scale (Turkish version of scale) were applied. This one-dimensional scale compose of nine items scored between 1 (completely disagree) and 7 (completely agree). The minimum total value was 7 and the maximum total value was 63. The cut-off value for severe fatigue was 36 and the highest total value is meant severe fatigue.

The Modified Medical Research Council dyspnea scale were performed to determine dyspnea perception during daily living activities. This categorical scale consisting of five expressions are scored from '0' to '4'. The minimum value was 0 which means no complain about dyspnea apart from strenuous exercise; the maximum value was 4 which means too breathless for leaving the house or dyspnea while getting dressed. The highest value was refered to severe shortness of breath during activities of daily living.

To evaluate pain severity, visual analog scale were used. The minimum value was 0 mm (no pain) and the maximum value was 100 mm (worst pain). The highest score was 100 mm which was meant worse pain severity.

Gazi University

Prof.Dr

The Montreal Cognitive Evaluation Scale will be used to evaluate the cognitive functions of the participants.

Evaluation of Physical Activity Level: The Turkish validity and reliability of the International Physical Activity Questionnaire Short Form made by Sağlam et al. will be used.

Evaluation of Quality of Life: It will be evaluated by the European Organization for Cancer Research and Treatments QLQ-C30 questionnaire.

Fatigue Evaluation: A fatigue severity scale consisting of 9 items will be used.

Dyspnea Assessment: The Modified Medical Research Council Dyspnea Scale will be used.

Respiratory Muscle Endurance: Evaluation will be done by respiratory muscle endurance test at constant threshold load with a Power Breathe device and according to the metronome warning and a MOXY monitor will be used. In evaluation of dual-task performance, an auditory task test will be performed while walking on the treadmill.

Evaluation of Dual Task Performance

cakır

Lung cancer is one of the most diagnosed cancer types worldwide, according to GLOBOCAN data published in 2020. According to these data, lung cancer comes second after breast cancer with 2,206,771 new diagnoses worldwide in 2020.

According to Türkiye's data for 2020, 41,264 new lung cancer diagnoses made. Lung cancer tumors are divide into two main histological groups non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Current medical treatment methods for lung cancer are surgical resection, chemotherapy, radiotherapy, and targeted therapies. Cancer treatments can be administered as a combination of these methods appropriately selected for patients.

Advances in treatment methods in recent years have increased survival and prolonged life expectancy. However, these treatment methods may affect patients in various areas from functional independence to quality of life.

Cancer treatments can cause various cognitive impairments such as memory, executive functions, and concentration.

In particular, a significant number of cancer patients receiving chemotherapy report cognitive disturbances that include attention problems, memory loss, and mixed thought processes ('chemobrain' or 'chemofog?), often accompanied by mood disorders and fatigue.

Despite recent large cohort studies using neuropsychological testing and neuroimaging in cancer patients undergoing chemotherapy, it remains unclear whether cognitive deficits are due to treatment, cancer itself, and/or psychological factors.

Patients with cognitive impairment due to chemotherapy reported that they had difficulty performing and completing simple tasks such as preparing meals, keeping track of bills and paying, or getting ready to go out, and needed additional time to perform these tasks.

They may also find it difficult to perform necessary work-related tasks and then need to change jobs or cease employment altogether.

Therefore, treatment-related cognitive impairment can have a significant impact on cognitive, occupational, and social functioning, all of which can result in significant personal problems and, in many cases, reduced quality of life.

During daily activities, we often need to perform multiple tasks at the same time. These tasks are usually cognitive and motor tasks.

A dual-task is the simultaneous execution of two tasks that have different objectives and can performed independently. In this case, attention should be focused on two tasks at the same time. These tasks can be measured separately.

Deteriorated cognitive function due to cancer and its treatments can affect the dual-task performance of individuals in their daily lives and reduce their quality of life.

Respiratory symptoms can be seen in lung cancer and post-cancer survival. Cancer itself and treatments can affect the cardiorespiratory system.

Considering that the number of individuals living with lung cancer increases every year, the evaluation of dual-task performance and respiratory muscle endurance, which is related to the cognitive status of individuals, and if necessary, adding them to the rehabilitation program can reduce the symptoms of individuals and increase their quality of life.

The aim of this study is to evaluate dual-task performance and respiratory muscle endurance in patients with lung cancer and compare them with healthy individuals.

H0: Dual-task performance and respiratory muscle endurance of patients with lung cancer are not different from healthy controls.

H1: Dual-task performance and respiratory muscle endurance values of patients with lung cancer are different from healthy controls.

Place and time of research:

Hacettepe University Faculty of Physical Therapy and Rehabilitation Cardiopulmonary It will be held in the Rehabilitation Unit. Between January 2024 and July 2024 It is planned to collect data and write the study.

Working Design:

Respiration as an outcome measure to determine the sample size of our study. Analysis was done according to muscle endurance. Analysis G\*Power analysis system (G\*Power Software version 3.1.9.3, Heinrich Heine University, Düsseldorf Germany) was made using For the power of our study to be 80%, at least 25 individuals with lung cancer should be included. 20% patient loss At least 30 lung cancer patients were included in the study, as was thought that will be. Age and gender-matched with the patient group, undiagnosed, 30 individuals consisting of volunteers will form the control group.

Individuals who will participate in the study are informed about the study verbally and in writing, An informed consent form will be obtained.

Research method and data collection tools:

Due to the COVID-19 pandemic, mask, distance, and hygiene rules will be followed to prevent transmission to or from participants. The patients will be taken into the study one by one and the measuring devices used after each patient will be disinfected and the unit will be ventilated.

All necessary infection control rules will be followed.

1. Demographic information: Participants' age, diagnosis, medical history, radiotherapy (number of days), chemotherapy (number of cures), occupation, body weight, height, BMI, history, family history, lifestyle characteristics (smoking, alcohol use), breathing stenosis, cough and sputum will be recorded.
2. Evaluation of Cognitive Function: The Montreal Cognitive Evaluation Scale (MOCA) will be used to evaluate the cognitive functions of the participants.

   MOCA was developed to measure different stages of cognitive impairment. It evaluates cognitive behaviors such as attention and concentration, executive functions, language, memory, visuospatial skills, abstract thinking and calculation. As memory tasks, recall from short-term memory, learning five words and recalling after five minutes; clock drawing test and three-dimensional cube painting as tasks requiring visuospatial skills; as tasks related to executive functions, tracing test, combining sequential number and letter patterns, verbal fluency and two-item abstract thinking task; sequential subtraction and forward-backward number space as attention, concentration, and working memory tasks; As language-related tasks, it includes questions about naming three pictures of animals, repeating two complex sentences, and time and place orientation.

   The highest possible score is 30 and the lowest score is 0. If the score is 21 and above, the cognitive level of the individual is considered normal.
3. Evaluation of Physical Activity Level: The Turkish validity and reliability of the International Physical Activity Questionnaire Short Form made by Sağlam et al. will be used.

   This questionnaire provides information on time spent in walking, moderate and vigorous physical activity. Time spent sitting is not included in the total score and is considered a separate question.

   The sum of moderate-intensity activity, vigorous activity, frequency of walking (days) and duration (minutes) is used to calculate the total score. The score in MET x minute units is obtained by multiplying the minute of activity with the MET score.

   For analysis of IPAQ data, it is calculated on walking: 3.3 METs, moderate-intensity physical activity: 4.0 METs, vigorous physical activity: 8.0 METs.

   People can be grouped according to their physical activity levels as 'inactive', 'minimally active', 'very active'.
4. Evaluation of Quality of Life: It will be evaluated by the European Organization for Cancer Research and Treatments (EORTC) QLQ-C30 questionnaire. The scale consists of the sub-headings of functional difficulties, general health status and symptom control and includes 30 questions.

   The lowest possible score is 0, and the highest score is 100. Its Turkish validity and reliability were evaluated by Cankurtaran friends in 2008.
5. Fatigue Evaluation: A fatigue severity scale consisting of 9 items will be used. The individual should answer the questions by thinking about the last week. Each item is scored between 1 and 7 in itself. 1 point indicates strongly disagree, 7 points strongly agree. The total score that can be obtained is a minimum of 9 and a maximum of 63. The scale score is the arithmetic mean of the total score obtained from nine items. As the scale score increases, the severity of fatigue increases. A total score of 36 and above or a scale score of 4 and above indicates severe fatigue in patients.
6. Dyspnea Assessment: The Modified Medical Research Council (MMRC) Dyspnea Scale will be used. The individual is asked to choose one of the 5 statements that best describe shortness of breath. A score of 0 indicates no shortness of breath except during vigorous exercise, while 4 points indicate that there is shortness of breath when getting out or getting dressed or undressing.
7. Evaluation of Respiratory Muscle Endurance: A Power Breathe device will be used in the evaluation of respiratory muscle endurance. Evaluation will be done by respiratory muscle endurance test at constant threshold load.

   The device we set with the value corresponding to 60% of the maximal inspiratory pressure will be placed in the mouth and the nose will be closed with a clip. The individual will be asked to breathe normally within the device for 10 minutes according to the metronome warning.

   Before applying the test, if the person feels too short of breath during the test, they will be informed that they can remove the device and thus the test will end. The result values will be obtained by multiplying the test time, the test time and the pressure value corresponding to the time.

   A MOXY monitor will be used to measure tissue oxygenation of the intercostal muscles during the test.
8. Evaluation of Dual-Task Performance: In evaluation of dual-task performance, an auditory task test will be performed while walking on the treadmill.

Patients will be asked to make choices on the computer based on the commands coming from the headphones while first standing on the treadmill, then walking at their preferred speed, and finally at speed higher than their preferred speed.

First, the speed preferred by individuals will be found. A progressive speed test will be used for this, in which the speed increases in 15 seconds. In order not to be affected by the numerical value, the speed part of the treadmill will be closed with the help of paper and hidden from the individual.

The participant will be asked to indicate when he has reached his preferred speed in each test. The average preferred walking speed will be found by averaging the preferred speeds in all tests.

The participant will mark the appropriate correct option on the computer screen with the help of the mouse, according to the warning coming from the headphones during walking.

Individuals' response accuracy will be used as an outcome measure.

Evaluation of Dual Task Performance and Respiratory Muscle Endurance in Patients With Lung Cancer

Individuals' response accuracy will be used as an outcome measure.

It will be done with the Power Breathe device at 60% of the maximal inspiratory pressure at a fixed threshold load and the time the patient can sustain will be recorded. The resulting measurement is the product of the test time and the pressure measurement corresponding to the test time.

Tissue oxygenation of the intercostal muscles during the respiratory muscle endurance test. The MOXY monitor will be used to measure tissue oxygenation of the intercostal muscles during the test. The Moxy monitor measures local oxygen saturation and total hemoglobin in muscle capillaries using the near infrared spectrum (NIRS).

The fatigue severity scale, consisting of a total of 9 items, will be used. The individual should answer the questions by thinking about the last week. Each item is scored between 1 and 7. A total score of 36 and above or a scale score of 4 and above indicates severe fatigue in patients.

It will be evaluated by the European Organization for Cancer Research and Treatments (EORTC) QLQ-C30 questionnaire.

It will be evaluated by International Physical Activity Questionnaire Short Form

It will be evaluated by The Montreal Cognitive Evaluation Scale. The highest score that can be obtained is 30 and the lowest score is 0. If the score is 21 or above, the individual's cognitive level is considered normal.

Hacettepe University

Physiotherapist

Symptoms and General Pathology

Blood and Lymph Conditions

Anxiety Disorders

Fatigue

Dyspnea

Hematologic Neoplasms

Hematologic Diseases

Newly diagnosed hematologic malignant patients included in the study. Inclusion and exclusion criteria were considered.

Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.

Zeliha Çelik, Pt

Meral Boşnak Güçlü, Pt, Phd

Zübeyde Nur Özkurt, MD, Phd

Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes. Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms.

Adverse effects of hematologic malignancies and treatments cause abnormality in physical function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic stem cell transplantation, which may have side effects on the body systems are used in early or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased physical functioning and deterioration in the quality of life are indirect side effects seen in patients.

In the literature, side effects of hematological malignancies have been investigated after treatment in patients. However, no study investigated exercise capacity, quality of life, physical activity level and pulmonary functions on newly diagnosed hematologic malignant patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly diagnosed hematologic malignant patients and healthy controls.

According to sample size calculation 30 newly diagnosed hematologic malignant patients and 30 healthy individuals will be included. Before treatment submaximal exercise capacity, physical activity, quality of life, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, anxiety and depression will be evaluated. Primary outcome measurements are exercise capacity, physical activity, quality of life, secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, dyspnea and fatigue perception, anxiety and depression.

Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients

Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients

There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.

Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)

The Functional Assessment of Cancer Therapy-Anemia (FACT-An)

Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)

Evaluated using respiratory muscle trainer (POWERbreathe)

Evaluated using Modified Medical Research Council Dyspnea scale (MMRC)

Evaluated using Hospital Anxiety and Depression Scale

Montgomery-Åsberg Depression Rating Scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Surgery Types in Patients With Pulmonary Nodules	NCT04805723	Pulmonary Nodul...	VATS Thoracotomy	18 Years - 80 Years	Gazi University
Evaluation of Dual Task Performance and Respiratory Muscle Endurance in Patients With Lung Cancer	NCT06251570	Lung Cancer	Evaluation of D...	18 Years - 65 Years	Hacettepe University
Evaluation of Dual Task Performance and Respiratory Muscle Endurance in Patients With Lung Cancer	NCT06251570	Lung Cancer	Evaluation of D...	18 Years - 65 Years	Hacettepe University
Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients	NCT03212560	Hematologic Mal...		18 Years - 65 Years	Gazi University

Spots Global Cancer Trial Database for respiratory muscle endurance