Effect of Breathing Exercise on Fatigue in Patients With Pulmonary Tuberculosis

NCT ID: NCT06171646

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis, Pulmonary Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental, Breathing Group

Breathing exercises were applied to the participants.

Group Type EXPERIMENTAL

breathing exercise

Intervention Type BEHAVIORAL

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.

No Intervention: Standard care

Participants received standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

breathing exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sema Aytaç, PhD

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sema Aytaç, PhD

Asist Prof. Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5122023

Identifier Type: -

Identifier Source: org_study_id