Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-06 @ 12:49 AM
Study NCT ID:
NCT06477367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Dyspnea, Activity and Sleep in COPD by Video-Based Breathing Exercises
Sponsor:
Bartın Unıversity
Organization:
Study Overview
Official Title:
The Effect of Video-Based Breathing Exercises Taught to COPD Patients on Dyspnea Severity, Activity Level, and Sleep Quality
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Chronic Obstructive Pulmonary Disease (COPD) is one of the most prevalent and high-mortality chronic diseases worldwide. Symptoms such as dyspnea, cough, sleep disturbances, fatigue, restricted activity levels, anxiety, and depression develop in COPD patients, negatively affecting their quality of life. Dyspnea, associated with various symptoms in COPD patients such as reduced activity levels and sleep disturbances, is a significant issue. Therefore, effective management of dyspnea will contribute to reducing other important problems associated with COPD.
One of the non-pharmacological methods used in managing these symptoms associated with COPD is breathing exercises. Particularly, pursed-lip breathing exercises and diaphragmatic breathing exercises are recommended for symptom management in COPD patients in the literature.
The aim of this study was to learn the effects of video-based breathing exercises (pursed lips and diaphragmatic breathing) training given to COPD patients over 18 years of age on the severity of dyspnea experienced by the patient, activity level and sleep quality. The main question it aims to answer is:
Does the use of video-based breathing exercises for 30 days result in a decrease in dyspnea severity and an increase in activity level and sleep quality in COPD patients over 18 years of age? Patients will receive video-based breathing exercises lasting approximately 5-7 minutes and will perform the breathing exercises regularly for 30 days, keep a diary and receive follow-up messages (sms). Afterwards, dyspnea severity, activity level and sleep quality will be assessed again, both in the group itself and in comparison with the control group that did not receive this education and follow-up.
One of the non-pharmacological methods used in managing these symptoms associated with COPD is breathing exercises. Particularly, pursed-lip breathing exercises and diaphragmatic breathing exercises are recommended for symptom management in COPD patients in the literature.
The aim of this study was to learn the effects of video-based breathing exercises (pursed lips and diaphragmatic breathing) training given to COPD patients over 18 years of age on the severity of dyspnea experienced by the patient, activity level and sleep quality. The main question it aims to answer is:
Does the use of video-based breathing exercises for 30 days result in a decrease in dyspnea severity and an increase in activity level and sleep quality in COPD patients over 18 years of age? Patients will receive video-based breathing exercises lasting approximately 5-7 minutes and will perform the breathing exercises regularly for 30 days, keep a diary and receive follow-up messages (sms). Afterwards, dyspnea severity, activity level and sleep quality will be assessed again, both in the group itself and in comparison with the control group that did not receive this education and follow-up.
Detailed Description:
Chronic Obstructive Pulmonary Disease (COPD) stands as a prominent progressive chronic condition, with approximately 210 million individuals affected globally, placing it third in terms of global mortality. COPD is recognized as a widespread, preventable, and manageable ailment marked by ongoing airflow restriction linked to chronic inflammation triggered by harmful gases and particles. Patients with COPD commonly experience symptoms like shortness of breath, coughing, disrupted sleep, fatigue, limited physical activity, as well as feelings of anxiety and depression.
Nurses play a crucial role in evaluating and addressing symptoms in COPD patients. They can utilize non-pharmacological techniques such as respiratory exercises, progressive relaxation exercises, reflexology, and yoga to help manage and alleviate dyspnea. Pursed-lip breathing, deep breathing, and diaphragmatic breathing exercises are commonly recommended for controlling hyperventilation and addressing dyspnea in COPD patients. Pursed-lip breathing has been shown to lower respiratory rate, decrease carbon dioxide levels, and increase oxygen levels and tidal volume in COPD patients. Additionally, diaphragmatic breathing exercises have been found to boost tidal volume and oxygen levels while reducing respiratory rate in COPD patients.
Sleep problems develop in 40% of COPD patients. Dyspnea in COPD patients often leads to sleep disturbances. Additionally, cough and sputum-induced insomnia affect daily life activities in COPD patients. Adequate sleep has a positive effect on respiratory and gas exchange functions in respiratory system diseases. Therefore, managing dyspnea in COPD patients will also reduce their sleep problems.
Physical activity level is associated with mortality in COPD patients. Furthermore, it has been reported that good physical activity reduces the severity of COPD-related symptoms and improves quality of life. Factors such as dyspnea, lung capacity, and inflammation negatively affect activity levels in COPD patients. Studies in the literature suggest that physical exercise programs rather than respiratory exercises increase physical activity levels in COPD patients.
In conclusion, while studies in the literature report positive effects of respiratory exercises on dyspnea management, no studies examining the effect of respiratory exercises on sleep quality and physical activity were found. This study is planned to investigate the effect of pursed-lip breathing exercises and diaphragmatic breathing exercises on dyspnea severity, activity level, and sleep quality in COPD patients.
Research Method:
The study is planned as a randomized controlled design.
Data Collection Tools:
* 6-minute walk test:This test is used to evaluate functional capacity by measuring the distance walked within a certain period of time. In the 6-minute walk test, the patient walks as fast as possible, but without running, in a straight corridor of 30 meters. The distance walked is measured. During the test, the patient should not change their pace or speed. It is known that patients with poor 6-minute walk test results have a poor prognosis.
* Patient Information Form: In the form created in line with the literature information; socio-demographic information of the participant, information about the disease and other chronic diseases, medications used, and habits are obtained.
* Modified Borg Scale (MBS)
* Saint George Respiratory Questionnaire (SGRQ)
* Asthma and COPD Sleep Scale
Data Collection:
Patients receiving treatment for COPD at Bartın State Hospital Chest Diseases Service will form the sample. Patients who meet the inclusion criteria for the study will be randomized using a computer-assisted randomization system. Informed Voluntary Consent Form will be obtained from patients who agree to participate in the study, and then the Patient Information Form, Modified Borg Scale, Saint George Respiratory Questionnaire (Activity sub-score), and Asthma and Chronic Obstructive Pulmonary Disease Sleep Scale will be completed. After the pre-test, patients in the experimental group will be taught the pursed-lip breathing exercise and diaphragmatic breathing exercise recommended for COPD patients by the Turkish Thoracic Society. Additionally, patients will be shown a 5-7 minute instructional video prepared by the researchers regarding this. The educational videos will be sent to the researchers' mobile phones via WhatsApp for patients to remember the exercise technique. Patients will be instructed to perform these exercises regularly for 15 minutes three times a day for four weeks. To ensure that patients perform the exercises regularly, an exercise diary will be created and provided to them, and a reminder SMS message will be sent by the researchers at the same time every day. The control group will receive the clinic's routine dyspnea care protocol. After four weeks, final tests will be administered to both groups, and the study will be concluded.
Population and Sample:
The population of the study consists of patients treated with COPD diagnosis at Bartın State Hospital Chest Diseases Service. The sample size was calculated as 56 patients, with 28 in the intervention group and 28 in the control group, taking into account data obtained from a similar study with d=0.68, power=0.80, α=0.05, and β=0.20. Considering that the sample size may decrease due to different reasons in the study, it is planned to have a sample of 60 individuals, with 30 patients in each group.
Dependent and Independent Variables:
Independent variables: Socio-demographic characteristics of patients diagnosed with COPD (Age, gender, education, etc.), respiratory exercises (pursed-lip breathing exercise and diaphragmatic breathing exercise) Dependent variables: Vital signs (respiratory rate, SpO2 value, heart rate, blood pressure), 6-minute walk test, Modified Borg Scale score, Saint George Respiratory Questionnaire (Activity score) score, COPD sleep quality scale
Hypotheses:
H1: The application of respiratory exercises in COPD patients has a positive effect on reducing dyspnea severity.
H2: The application of respiratory exercises in COPD patients has a positive effect on activity level.
H3: The application of respiratory exercises in COPD patients has a positive effect on sleep quality.
Data Evaluation:
The SPSS program will be used for statistical analysis of the obtained data. Descriptive statistical analyses (number, percentage, mean, standard deviation) will be performed for the data. The Shapiro-Wilk test will be used to test whether the data show normal distribution. If the data show normal distribution, paired samples t-test and one-way ANOVA test will be used for matched sets. If the data do not show normal distribution, Kruskal Wallis and Wilcoxon tests will be used. Values with a p-value below 0.05 will be considered statistically significant.
Nurses play a crucial role in evaluating and addressing symptoms in COPD patients. They can utilize non-pharmacological techniques such as respiratory exercises, progressive relaxation exercises, reflexology, and yoga to help manage and alleviate dyspnea. Pursed-lip breathing, deep breathing, and diaphragmatic breathing exercises are commonly recommended for controlling hyperventilation and addressing dyspnea in COPD patients. Pursed-lip breathing has been shown to lower respiratory rate, decrease carbon dioxide levels, and increase oxygen levels and tidal volume in COPD patients. Additionally, diaphragmatic breathing exercises have been found to boost tidal volume and oxygen levels while reducing respiratory rate in COPD patients.
Sleep problems develop in 40% of COPD patients. Dyspnea in COPD patients often leads to sleep disturbances. Additionally, cough and sputum-induced insomnia affect daily life activities in COPD patients. Adequate sleep has a positive effect on respiratory and gas exchange functions in respiratory system diseases. Therefore, managing dyspnea in COPD patients will also reduce their sleep problems.
Physical activity level is associated with mortality in COPD patients. Furthermore, it has been reported that good physical activity reduces the severity of COPD-related symptoms and improves quality of life. Factors such as dyspnea, lung capacity, and inflammation negatively affect activity levels in COPD patients. Studies in the literature suggest that physical exercise programs rather than respiratory exercises increase physical activity levels in COPD patients.
In conclusion, while studies in the literature report positive effects of respiratory exercises on dyspnea management, no studies examining the effect of respiratory exercises on sleep quality and physical activity were found. This study is planned to investigate the effect of pursed-lip breathing exercises and diaphragmatic breathing exercises on dyspnea severity, activity level, and sleep quality in COPD patients.
Research Method:
The study is planned as a randomized controlled design.
Data Collection Tools:
* 6-minute walk test:This test is used to evaluate functional capacity by measuring the distance walked within a certain period of time. In the 6-minute walk test, the patient walks as fast as possible, but without running, in a straight corridor of 30 meters. The distance walked is measured. During the test, the patient should not change their pace or speed. It is known that patients with poor 6-minute walk test results have a poor prognosis.
* Patient Information Form: In the form created in line with the literature information; socio-demographic information of the participant, information about the disease and other chronic diseases, medications used, and habits are obtained.
* Modified Borg Scale (MBS)
* Saint George Respiratory Questionnaire (SGRQ)
* Asthma and COPD Sleep Scale
Data Collection:
Patients receiving treatment for COPD at Bartın State Hospital Chest Diseases Service will form the sample. Patients who meet the inclusion criteria for the study will be randomized using a computer-assisted randomization system. Informed Voluntary Consent Form will be obtained from patients who agree to participate in the study, and then the Patient Information Form, Modified Borg Scale, Saint George Respiratory Questionnaire (Activity sub-score), and Asthma and Chronic Obstructive Pulmonary Disease Sleep Scale will be completed. After the pre-test, patients in the experimental group will be taught the pursed-lip breathing exercise and diaphragmatic breathing exercise recommended for COPD patients by the Turkish Thoracic Society. Additionally, patients will be shown a 5-7 minute instructional video prepared by the researchers regarding this. The educational videos will be sent to the researchers' mobile phones via WhatsApp for patients to remember the exercise technique. Patients will be instructed to perform these exercises regularly for 15 minutes three times a day for four weeks. To ensure that patients perform the exercises regularly, an exercise diary will be created and provided to them, and a reminder SMS message will be sent by the researchers at the same time every day. The control group will receive the clinic's routine dyspnea care protocol. After four weeks, final tests will be administered to both groups, and the study will be concluded.
Population and Sample:
The population of the study consists of patients treated with COPD diagnosis at Bartın State Hospital Chest Diseases Service. The sample size was calculated as 56 patients, with 28 in the intervention group and 28 in the control group, taking into account data obtained from a similar study with d=0.68, power=0.80, α=0.05, and β=0.20. Considering that the sample size may decrease due to different reasons in the study, it is planned to have a sample of 60 individuals, with 30 patients in each group.
Dependent and Independent Variables:
Independent variables: Socio-demographic characteristics of patients diagnosed with COPD (Age, gender, education, etc.), respiratory exercises (pursed-lip breathing exercise and diaphragmatic breathing exercise) Dependent variables: Vital signs (respiratory rate, SpO2 value, heart rate, blood pressure), 6-minute walk test, Modified Borg Scale score, Saint George Respiratory Questionnaire (Activity score) score, COPD sleep quality scale
Hypotheses:
H1: The application of respiratory exercises in COPD patients has a positive effect on reducing dyspnea severity.
H2: The application of respiratory exercises in COPD patients has a positive effect on activity level.
H3: The application of respiratory exercises in COPD patients has a positive effect on sleep quality.
Data Evaluation:
The SPSS program will be used for statistical analysis of the obtained data. Descriptive statistical analyses (number, percentage, mean, standard deviation) will be performed for the data. The Shapiro-Wilk test will be used to test whether the data show normal distribution. If the data show normal distribution, paired samples t-test and one-way ANOVA test will be used for matched sets. If the data do not show normal distribution, Kruskal Wallis and Wilcoxon tests will be used. Values with a p-value below 0.05 will be considered statistically significant.
Study Oversight
Has Oversight DMC:
False
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?: