Tuberculosis, PulmonaryNCT06171646
Effect of Breathing Exercise on Fatigue in Patients With Pulmonary Tuberculosis
A study testing breathing exercise in people with Tuberculosis, Pulmonary and Fatigue, run by Sema Aytaç, PhD at 1 site in Turkey (Türkiye).
Trial summary
Tuberculosis is a chronic, necrotic infectious disease with very different clinical appearances, caused by a group of mycobacteria defined as M. tuberculosis complex. Although there is a vaccine and can be treated with combined medications, this health problem remains important all over the world, especially in poor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Fatigue
- What is being tested?
- breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Sep 2023
- 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
- Being literate Being diagnosed with Pulmonary Tuberculosis and completing the 15th day of treatment Volunteering to participate in the study Being 18 years or older No communication problems Not having mental confusion or any psychiatric problems Not having Multiple Drug Resistance (MDR) Using a communication tool
Who cannot join
- Reluctance to participate in the study Being a patient with Multiple Drug Resistance (MDR) Not being diagnosed with Pulmonary Tuberculosis and not having completed the 15th day of treatment Having any psychiatric problems Scoring '0' on the Piper Fatigue scale Not using communication tools
Trial locations and contacts
1 site in 1 country.
About this study
Tuberculosis is a chronic, necrotic infectious disease with very different clinical appearances, caused by a group of mycobacteria defined as M. tuberculosis complex. Although there is a vaccine and can be treated with combined medications, this health problem remains important all over the world, especially in poor countries. Generally, respiratory symptoms that occur in a person with tuberculosis include cough, phlegm, hemoptysis, chest pain, and shortness of breath for more than three weeks. If there is a partial obstruction in the bronchi due to the compression of enlarged lymph nodes, it causes a whezing sound accompanied by shortness of breath. In tuberculosis, contagion is brought under control with effective treatment by regular use of drugs. In addition, the symptoms of the patients are relieved until they recover. However, the fatigue of the patients may continue. The disease may continue. In addition to having an effect, fatigue may also occur due to the side effects of many tuberculosis drugs. Therefore, patients experiencing fatigue while taking tuberculosis drugs may cause them to become uncooperative in drug use, multidrug-resistant tuberculosis, serious complications and higher treatment costs. Another method used in addition to the treatment of chronic respiratory system diseases such as tuberculosis is pulmonary rehabilitation.Pulmonary rehabilitation consists of patient education, psychosocial support, aerobic and strengthening breathing exercises and physical training programs. Among the breathing exercises that are considered to be one of the important components of pulmonary rehabilitation, pursed-lip breathing and diaphragmatic breathing exercises are frequently used in chronic respiratory system diseases. However, no study has been found examining the effects of pursed-lip breathing and diaphragmatic breathing exercises on fatigue in tuberculosis patients. Pursed-lip breathing technique ensures maximum emptying of the alveoli by providing controlled expiration, thus helping to reduce the respiratory rate by increasing the activity of the inspiratory and expiratory muscles, increasing gas exchange and tidal volume. During diaphragmatic breathing exercise, since the diaphragm muscle is used instead of accessory muscles, the respiratory load decreases, thus the ventilation level of the lungs increases and breathing is supported. It has been reported in the literature that the deep breathing technique is effective in controlling the emotional states of tuberculosis patients, and that deep breathing exercises applied to pulmonary TB patients are effective in reducing the respiratory rate. However, since no study was found in the literature review that evaluated the effect of breathing exercise applied to TB patients on fatigue, this study was planned to examine the effect of breathing exercise applied to patients diagnosed with TB on fatigue.
- Conditions
- Tuberculosis, Pulmonary, Fatigue
- Being tested
- breathing exercise
- Medical subject headings
- Tuberculosis, Pulmonary, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exerciseBehavioural
The patients in the intervention group will first be informed by the researcher about pursed lips and diaphragmatic breathing exercises through a face-to-face interview technique, and then the breathing exercises will be taught practically to each patient for approximately 30 minutes, and the first session will be held. Each session takes place once a day in the morning, lasts 10-15 minutes and is applied every day; Sessions other than the first session will consist of 10 pursed lip breathing exercises, relaxation (2 minutes) and 10 diaphragmatic breathing exercises; Three days a week, the researcher will be reminded via online video call once a day in the morning, and on the other days, the patients will be reminded by phone call that they will be asked to do themselves, and breathing exercises will be performed for a total of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental, Breathing Group | Experimental | Breathing exercises were applied to the participants. Receives: Behavioral: breathing exercise |
| No Intervention: Standard care | No intervention | Participants received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue during the Follow-up
Piper fatigue scale was applied. It varies between 0-10 points, with a higher score indicating increased fatigue.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sema Aytaç, PhD
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Sema Aytaç, PhD, Tuberculosis Network European Trialsgroup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171646
- Sponsor's protocol ID
- 5122023
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercise on Fatigue in Patients With Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT06171646
- Acronym / sponsor ID
- 5122023
- Conditions
- Tuberculosis, Pulmonary, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sema Aytaç, PhDResearch network
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Dec 2023 (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.
Tuberculosis is a chronic, necrotic infectious disease with very different clinical appearances, caused by a group of mycobacteria defined as M. tuberculosis complex. Although there is a vaccine and can be treated with combined medications, this health problem remains important all over the world, especially in poor countries. Generally, respiratory symptoms that occur in a person with tuberculosis include cough, phlegm, hemoptysis, chest pain, and shortness of breath for more than three weeks. If there is a partial obstruction in the bronchi due to the compression of enlarged lymph nodes, it causes a whezing sound accompanied by shortness of breath. In tuberculosis, contagion is brought under control with effective treatment by regular use of drugs. In addition, the symptoms of the patients are relieved until they recover. However, the fatigue of the patients may continue. The disease may continue. In addition to having an effect, fatigue may also occur due to the side effects of many tuberculosis drugs. Therefore, patients experiencing fatigue while taking tuberculosis drugs may cause them to become uncooperative in drug use, multidrug-resistant tuberculosis, serious complications and higher treatment costs. Another method used in addition to the treatment of chronic respiratory system diseases such as tuberculosis is pulmonary rehabilitation.Pulmonary rehabilitation consists of patient education, psychosocial support, aerobic and strengthening breathing exercises and physical training programs. Among the breathing exercises that are considered to be one of the important components of pulmonary rehabilitation, pursed-lip breathing and diaphragmatic breathing exercises are frequently used in chronic respiratory system diseases. However, no study has been found examining the effects of pursed-lip breathing and diaphragmatic breathing exercises on fatigue in tuberculosis patients. Pursed-lip breathing technique ensures maximum emptying of the alveoli by providing controlled expiration, thus helping to reduce the respiratory rate by increasing the activity of the inspiratory and expiratory muscles, increasing gas exchange and tidal volume. During diaphragmatic breathing exercise, since the diaphragm muscle is used instead of accessory muscles, the respiratory load decreases, thus the ventilation level of the lungs increases and breathing is supported. It has been reported in the literature that the deep breathing technique is effective in controlling the emotional states of tuberculosis patients, and that deep breathing exercises applied to pulmonary TB patients are effective in reducing the respiratory rate. However, since no study was found in the literature review that evaluated the effect of breathing exercise applied to TB patients on fatigue, this study was planned to examine the effect of breathing exercise applied to patients diagnosed with TB on fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental, Breathing Group | Experimental | Behavioral: breathing exerciseBreathing exercises were applied to the participants. |
| No Intervention: Standard care | No intervention | –Participants received standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being literate Being diagnosed with Pulmonary Tuberculosis and completing the 15th day of treatment Volunteering to participate in the study Being 18 years or older No communication problems Not having mental confusion or any psychiatric problems Not having Multiple Drug Resistance (MDR) Using a communication tool
Key exclusion criteria (1 listed)
- Reluctance to participate in the study Being a patient with Multiple Drug Resistance (MDR) Not being diagnosed with Pulmonary Tuberculosis and not having completed the 15th day of treatment Having any psychiatric problems Scoring '0' on the Piper Fatigue scale Not using communication tools
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 |
|---|---|---|
| breathing exerciseThe patients in the intervention group will first be informed by the researcher about pursed lips and diaphragmatic breathing exercises through a face-to-face interview technique, and then the breathing exercises will be taught practically to each patient for approximately 30 minutes, and the first session will be held. Each session takes place once a day in the morning, lasts 10-15 minutes and is applied every day; Sessions other than the first session will consist of 10 pursed lip breathing exercises, relaxation (2 minutes) and 10 diaphragmatic breathing exercises; Three days a week, the researcher will be reminded via online video call once a day in the morning, and on the other days, the patients will be reminded by phone call that they will be asked to do themselves, and breathing exercises will be performed for a total of four weeks. | Behavioural | Experimental, Breathing Group |
Primary outcome
Change in fatigue during the Follow-up
Time frame: 1 months
Piper fatigue scale was applied. It varies between 0-10 points, with a higher score indicating increased fatigue.
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 14 Dec 2023.
- 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 breathing exercise in people with Tuberculosis, Pulmonary and Fatigue, run by Sema Aytaç, PhD 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 1 inclusion and 1 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 14 Dec 2023. 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?
Change in fatigue during the Follow-up (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.