NCT06171646

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 6, 2023

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 months

Study Arms (2)

Experimental, Breathing Group

EXPERIMENTAL

Breathing exercises were applied to the participants.

Behavioral: breathing exercise

No Intervention: Standard care

NO INTERVENTION

Participants received standard care.

Interventions

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.

Experimental, Breathing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tuberculosis, PulmonaryFatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asist Prof. Dr

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations