Pulmonary Disease, Chronic ObstructiveNCT06477367
Changes in Dyspnea, Activity and Sleep in COPD by Video-Based Breathing Exercises
A study testing Video-Based Breathing Exercises in people with Pulmonary Disease, Chronic Obstructive, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Video-Based Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having cognitive impairment
- Not willing to participate in the study
- Failure to perform respiratory exercises regularly
- Having non-COPD lung diseases such as tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Video-Based Breathing Exercises Taught to COPD Patients on Dyspnea Severity, Activity Level, and Sleep Quality
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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Video-Based Breathing Exercises
- Keywords
- COPD, patient with COPD, pursed lip breathing exercise, video-based breathing exercises, dyspnea, sleep quality, activity level, diaphragmatic breathing exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Breathing ExercisesOther
Researchers will present a 5-7 minute instructional video aimed at helping participants recall the technique for performing the exercises. These instructional videos will be sent to the researchers' mobile phones via WhatsApp. Participants will be instructed to perform the exercises three times a day for 15 minutes each, for a period of 30 days. To encourage regular exercise, participants will be provided with an exercise diary, and researchers will send reminder SMS messages at the same time every day. The control group will receive the clinic's routine dyspnea care protocol. After thirty days, final tests will be administered to both groups, and the research will be concluded.
| Study group | Role | What they receive |
|---|---|---|
| The group receiving video-based training | Experimental | Researchers will present a 5-7 minute instructional video aimed at helping participants recall the technique for performing the exercises. These instructional videos will be sent to the researchers' mobile phones via WhatsApp. Participants will be instructed to perform the exercises three times a day for 15 minutes each, for a period of 30 days. To encourage regular exercise, participants will be provided with an exercise diary, and researchers will send reminder SMS messages at the same time every day. Receives: Other: Video-Based Breathing Exercises |
| The group not receiving video-based training | No intervention | The control group will receive the clinic's routine dyspnea care protocol. After thirty days, final tests will be administered to both groups, and the research will be concluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
Dyspnea severity of the COPD patient will be evaluated with Modified Borg Scale(MBS). It was aimed to determine the change in dyspnea severity in COPD patients who received and regularly practiced video-based breathing exercises training. Modified Borg Scale (MBS): As scores increase, dyspnea severity increases (0: None, 0.5: Very, very light, 1: Very light, 2: Light, 3: Moderate, 4: Somewhat severe, 5: Severe, 6: ..., 7: Very severe, 8: ..., 9: Very, very severe, 10: Maximum).
Measured: pre-intervention (first measurement)
St. George's respiratory questionnaire (for activity level of the COPD patients)
30 days of regular breathing exercise was aimed to realize the change in the activity level of patients with COPD. The change in activity level will be measured by Saint George's Respiratory Questionnaire (SGRQ). Saint George's Respiratory Questionnaire (SGRQ): The questionnaire consists of 50 items and three subscales: symptoms (8 items), activity (16 items), and impacts of the disease (26 items). Each item in the scale has an empirically determined weight. The questionnaire evaluates respiratory symptoms, activities limited by dyspnea, and the overall impact on daily life. Each subscale of the questionnaire is scored separately, and a total score is calculated. The total score ranges from 0 to 100, where a score of 0 indicates no impairment in quality of life, while a score of 100 indicates a progressive deterioration in quality of life.
Measured: pre-intervention (first measurement)
Chronic Obstructive Pulmonary Disease and Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
30 days of regular breathing exercise was aimed to realize the change in the sleep qualty of patients with COPD. The Asthma COPD Sleep Scale is a Likert scale consisting of a total of 7 items. A high scale score indicates poor sleep quality and a low scale score indicates good sleep quality. In the scale, scores can range from a minimum of 0 to a maximum of 35. However, the original version of the scale does not specify minimum, maximum, or cut-off scores. A higher total score indicates poorer sleep quality, while a lower total score reflects better sleep quality. Relevant explanations regarding this matter are also provided.
Measured: pre-intervention (first measurement)
Secondary outcomes (3)
Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
Dyspnea severity of the COPD patient will be evaluated with Modified Borg Scale(MBS). It was aimed to determine the change in dyspnea severity in COPD patients who received and regularly practiced video-based breathing exercises training. Modified Borg Scale (MBS): As scores increase, dyspnea severity increases (0: None, 0.5: Very, very light, 1: Very light, 2: Light, 3: Moderate, 4: Somewhat severe, 5: Severe, 6: ..., 7: Very severe, 8: ..., 9: Very, very severe, 10: Maximum).
Measured: Last measurement 4 weeks after the first measurement (30 days later)
St. George's respiratory questionnaire (for activity level of the COPD patients)
30 days of regular breathing exercise was aimed to realize the change in the activity level of patients with COPD. The change in activity level will be measured by Saint George's Respiratory Questionnaire (SGRQ). Saint George's Respiratory Questionnaire (SGRQ): The questionnaire consists of 50 items and three subscales: symptoms (8 items), activity (16 items), and impacts of the disease (26 items). Each item in the scale has an empirically determined weight. The questionnaire evaluates respiratory symptoms, activities limited by dyspnea, and the overall impact on daily life. Each subscale of the questionnaire is scored separately, and a total score is calculated. The total score ranges from 0 to 100, where a score of 0 indicates no impairment in quality of life, while a score of 100 indicates a progressive deterioration in quality of life.
Measured: Last measurement 4 weeks after the first measurement (30 days later)
Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
30 days of regular breathing exercise was aimed to realize the change in the sleep qualty of patients with COPD. The Asthma COPD Sleep Scale is a Likert scale consisting of a total of 7 items. A high scale score indicates poor sleep quality and a low scale score indicates good sleep quality. In the scale, scores can range from a minimum of 0 to a maximum of 35. However, the original version of the scale does not specify minimum, maximum, or cut-off scores. A higher total score indicates poorer sleep quality, while a lower total score reflects better sleep quality. Relevant explanations regarding this matter are also provided.
The effect of video-based breathing exercise training and regular practice on sleep quality will be measured with the same measurement tool (Asthma and Chronic Obstructive Pulmonary Disease Sleep Scale).
Measured: Last measurement 4 weeks after the first measurement (30 days later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start20 Jun 2024
- Primary completion20 Dec 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayfer Bayındır Çevik, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477367
- Sponsor's protocol ID
- BartınU_Bayındır Cevik_001
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albarrati AM, Gale NS, Munnery MM, Cockcroft JR, Shale DJ. Daily physical activity and related risk factors in COPD. BMC Pulm Med. 2020 Mar 5;20(1):60. doi: 10.1186/s12890-020-1097-y.
PubMed 32138714ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Burkow TM, Vognild LK, Johnsen E, Bratvold A, Risberg MJ. Promoting exercise training and physical activity in daily life: a feasibility study of a virtual group intervention for behaviour change in COPD. BMC Med Inform Decis Mak. 2018 Dec 18;18(1):136. doi: 10.1186/s12911-018-0721-8.
PubMed 30563507Ceyhan Y, Tekinsoy Kartin P. The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial. Trials. 2022 Aug 26;23(1):707. doi: 10.1186/s13063-022-06603-3.
PubMed 36028881Chang CH, Chuang LP, Lin SW, Lee CS, Tsai YH, Wei YF, Cheng SL, Hsu JY, Kuo PH, Yu CJ, Chen NH. Factors responsible for poor sleep quality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2016 Aug 8;16(1):118. doi: 10.1186/s12890-016-0281-6.
PubMed 27501837de Roos P, Lucas C, Strijbos JH, van Trijffel E. Effectiveness of a combined exercise training and home-based walking programme on physical activity compared with standard medical care in moderate COPD: a randomised controlled trial. Physiotherapy. 2018 Mar;104(1):116-121. doi: 10.1016/j.physio.2016.08.005. Epub 2017 Jul 14.
PubMed 28802772Hanania NA, O'Donnell DE. Activity-related dyspnea in chronic obstructive pulmonary disease: physical and psychological consequences, unmet needs, and future directions. Int J Chron Obstruct Pulmon Dis. 2019 May 24;14:1127-1138. doi: 10.2147/COPD.S188141. eCollection 2019.
PubMed 31213793Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. doi: 10.1136/thorax.56.11.880.
PubMed 11641515Ko FW, Tam W, Siu EHS, Chan KP, Ngai JC, Ng SS, Chan TO, Hui DS. Effect of short-course exercise training on the frequency of exacerbations and physical activity in patients with COPD: A randomized controlled trial. Respirology. 2021 Jan;26(1):72-79. doi: 10.1111/resp.13872. Epub 2020 Jun 15.
PubMed 32542906Ierodiakonou D, Bouloukaki I, Kampouraki M, Papadokostakis P, Poulorinakis I, Lampraki I, Athanasiou P, Schiza S, Tsiligianni I; Greek UNLOCK Group. Subjective sleep quality is associated with disease status in COPD patients. The cross-sectional Greek UNLOCK study. Sleep Breath. 2020 Dec;24(4):1599-1605. doi: 10.1007/s11325-020-02039-8. Epub 2020 Feb 26.
PubMed 32103395Lewthwaite H, Effing TW, Olds T, Williams MT. Physical activity, sedentary behaviour and sleep in COPD guidelines: A systematic review. Chron Respir Dis. 2017 Aug;14(3):231-244. doi: 10.1177/1479972316687224. Epub 2017 Feb 24.
PubMed 28774202McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
PubMed 25705944Mayer AF, Karloh M, Dos Santos K, de Araujo CLP, Gulart AA. Effects of acute use of pursed-lips breathing during exercise in patients with COPD: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):9-17. doi: 10.1016/j.physio.2017.08.007. Epub 2017 Aug 31.
PubMed 28969859McNicholas WT, Hansson D, Schiza S, Grote L. Sleep in chronic respiratory disease: COPD and hypoventilation disorders. Eur Respir Rev. 2019 Sep 25;28(153):190064. doi: 10.1183/16000617.0064-2019. Print 2019 Sep 30.
PubMed 31554703
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Based Breathing Exercises Taught to COPD Patients on Dyspnea Severity, Activity Level, and Sleep Quality
- ClinicalTrials.gov ID
- NCT06477367
- Acronym / sponsor ID
- BartınU_Bayındır Cevik_001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group receiving video-based training | Experimental | Other: Video-Based Breathing ExercisesResearchers will present a 5-7 minute instructional video aimed at helping participants recall the technique for performing the exercises. These instructional videos will be sent to the researchers' mobile phones via WhatsApp. Participants will be instructed to perform the exercises three times a day for 15 minutes each, for a period of 30 days. To encourage regular exercise, participants will be provided with an exercise diary, and researchers will send reminder SMS messages at the same time every day. |
| The group not receiving video-based training | No intervention | –The control group will receive the clinic's routine dyspnea care protocol. After thirty days, final tests will be administered to both groups, and the research will be concluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Having cognitive impairment
- Not willing to participate in the study
- Failure to perform respiratory exercises regularly
- Having non-COPD lung diseases such as tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Based Breathing ExercisesResearchers will present a 5-7 minute instructional video aimed at helping participants recall the technique for performing the exercises. These instructional videos will be sent to the researchers' mobile phones via WhatsApp. Participants will be instructed to perform the exercises three times a day for 15 minutes each, for a period of 30 days. To encourage regular exercise, participants will be provided with an exercise diary, and researchers will send reminder SMS messages at the same time every day. The control group will receive the clinic's routine dyspnea care protocol. After thirty days, final tests will be administered to both groups, and the research will be concluded. | Other | The group receiving video-based training |
Primary outcome
Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
Time frame: pre-intervention (first measurement)
Dyspnea severity of the COPD patient will be evaluated with Modified Borg Scale(MBS). It was aimed to determine the change in dyspnea severity in COPD patients who received and regularly practiced video-based breathing exercises training. Modified Borg Scale (MBS): As scores increase, dyspnea severity increases (0: None, 0.5: Very, very light, 1: Very light, 2: Light, 3: Moderate, 4: Somewhat severe, 5: Severe, 6: ..., 7: Very severe, 8: ..., 9: Very, very severe, 10: Maximum).
St. George's respiratory questionnaire (for activity level of the COPD patients)
Time frame: pre-intervention (first measurement)
30 days of regular breathing exercise was aimed to realize the change in the activity level of patients with COPD. The change in activity level will be measured by Saint George's Respiratory Questionnaire (SGRQ). Saint George's Respiratory Questionnaire (SGRQ): The questionnaire consists of 50 items and three subscales: symptoms (8 items), activity (16 items), and impacts of the disease (26 items). Each item in the scale has an empirically determined weight. The questionnaire evaluates respiratory symptoms, activities limited by dyspnea, and the overall impact on daily life. Each subscale of the questionnaire is scored separately, and a total score is calculated. The total score ranges from 0 to 100, where a score of 0 indicates no impairment in quality of life, while a score of 100 indicates a progressive deterioration in quality of life.
Chronic Obstructive Pulmonary Disease and Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
Time frame: pre-intervention (first measurement)
30 days of regular breathing exercise was aimed to realize the change in the sleep qualty of patients with COPD. The Asthma COPD Sleep Scale is a Likert scale consisting of a total of 7 items. A high scale score indicates poor sleep quality and a low scale score indicates good sleep quality. In the scale, scores can range from a minimum of 0 to a maximum of 35. However, the original version of the scale does not specify minimum, maximum, or cut-off scores. A higher total score indicates poorer sleep quality, while a lower total score reflects better sleep quality. Relevant explanations regarding this matter are also provided.
3 secondary outcomes
Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients)
Time frame: Last measurement 4 weeks after the first measurement (30 days later)
St. George's respiratory questionnaire (for activity level of the COPD patients)
Time frame: Last measurement 4 weeks after the first measurement (30 days later)
Asthma Sleep Impact Scale (for sleep qualty of the COPD patients)
Time frame: Last measurement 4 weeks after the first measurement (30 days later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 32138714Albarrati AM, Gale NS, Munnery MM, Cockcroft JR, Shale DJ. Daily physical activity and related risk factors in COPD. BMC Pulm Med. 2020 Mar 5;20(1):60. doi: 10.1186/s12890-020-1097-y.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 30563507Burkow TM, Vognild LK, Johnsen E, Bratvold A, Risberg MJ. Promoting exercise training and physical activity in daily life: a feasibility study of a virtual group intervention for behaviour change in COPD. BMC Med Inform Decis Mak. 2018 Dec 18;18(1):136. doi: 10.1186/s12911-018-0721-8.
- Background: PubMed 36028881Ceyhan Y, Tekinsoy Kartin P. The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial. Trials. 2022 Aug 26;23(1):707. doi: 10.1186/s13063-022-06603-3.
- Background: PubMed 27501837Chang CH, Chuang LP, Lin SW, Lee CS, Tsai YH, Wei YF, Cheng SL, Hsu JY, Kuo PH, Yu CJ, Chen NH. Factors responsible for poor sleep quality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2016 Aug 8;16(1):118. doi: 10.1186/s12890-016-0281-6.
- Background: PubMed 28802772de Roos P, Lucas C, Strijbos JH, van Trijffel E. Effectiveness of a combined exercise training and home-based walking programme on physical activity compared with standard medical care in moderate COPD: a randomised controlled trial. Physiotherapy. 2018 Mar;104(1):116-121. doi: 10.1016/j.physio.2016.08.005. Epub 2017 Jul 14.
- Background: PubMed 31213793Hanania NA, O'Donnell DE. Activity-related dyspnea in chronic obstructive pulmonary disease: physical and psychological consequences, unmet needs, and future directions. Int J Chron Obstruct Pulmon Dis. 2019 May 24;14:1127-1138. doi: 10.2147/COPD.S188141. eCollection 2019.
- Background: PubMed 11641515Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001 Nov;56(11):880-7. doi: 10.1136/thorax.56.11.880.
- Background: PubMed 32542906Ko FW, Tam W, Siu EHS, Chan KP, Ngai JC, Ng SS, Chan TO, Hui DS. Effect of short-course exercise training on the frequency of exacerbations and physical activity in patients with COPD: A randomized controlled trial. Respirology. 2021 Jan;26(1):72-79. doi: 10.1111/resp.13872. Epub 2020 Jun 15.
- Background: PubMed 32103395Ierodiakonou D, Bouloukaki I, Kampouraki M, Papadokostakis P, Poulorinakis I, Lampraki I, Athanasiou P, Schiza S, Tsiligianni I; Greek UNLOCK Group. Subjective sleep quality is associated with disease status in COPD patients. The cross-sectional Greek UNLOCK study. Sleep Breath. 2020 Dec;24(4):1599-1605. doi: 10.1007/s11325-020-02039-8. Epub 2020 Feb 26.
- Background: PubMed 28774202Lewthwaite H, Effing TW, Olds T, Williams MT. Physical activity, sedentary behaviour and sleep in COPD guidelines: A systematic review. Chron Respir Dis. 2017 Aug;14(3):231-244. doi: 10.1177/1479972316687224. Epub 2017 Feb 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Breathing Exercises in people with Pulmonary Disease, Chronic Obstructive, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Scale(MBS) (for dyspnea severity of the COPD patients) (time frame: pre-intervention (first measurement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06477367, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.