Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251570
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-04
Brief Title:
Evaluation of Dual Task Performance and Respiratory Muscle Endurance in Patients With Lung Cancer
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Evaluation of Dual Task Performance and Respiratory Muscle Endurance in Patients With Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 2206771 new diagnoses worldwide in 2020
According to Türkiyes data for 2020 41264 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 andor 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
According to Türkiyes data for 2020 41264 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 andor 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
Detailed Description:
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 GPower analysis system GPower Software version 3193 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 33 METs moderate-intensity physical activity 40 METs vigorous physical activity 80 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
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 GPower analysis system GPower Software version 3193 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 33 METs moderate-intensity physical activity 40 METs vigorous physical activity 80 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None