Clinical trial NCT06477367: Changes in Dyspnea, Activity and Sleep in COPD by Video-Based Breathing Exercises
Official title: The Effect of Video-Based Breathing Exercises Taught to COPD Patients on Dyspnea Severity, Activity Level, and Sleep Quality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
patient with COPD
pursed lip breathing exercise
video-based breathing exercises
dyspnea
sleep quality
activity level
diaphragmatic breathing exercise
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 and above
* Diagnosed with COPD for at least six months
* Modified Borg Dyspnea Scale score of at least 3
* Unable to complete the 6-minute walk test
* Not previously participated in a respiratory exercise program

Exclusion Criteria:

* Having cognitive impairment
* Not willing to participate in the study
* Failure to perform respiratory exercises regularly
* Having non-COPD lung diseases such as tuberculosis

Primary outcomes:
measure: Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
timeFrame: pre-intervention (first measurement)
measure: St. George's respiratory questionnaire (for activity level of the COPD patients)
timeFrame: pre-intervention (first measurement)
measure: Chronic Obstructive Pulmonary Disease and Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
timeFrame: pre-intervention (first measurement)
Secondary outcomes:
measure: Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
timeFrame: Last measurement 4 weeks after the first measurement (30 days later)
measure: St. George's respiratory questionnaire (for activity level of the COPD patients)
timeFrame: Last measurement 4 weeks after the first measurement (30 days later)
measure: Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
timeFrame: Last measurement 4 weeks after the first measurement (30 days later)
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartin University
Study officials:
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