Clinical trial NCT06597409: Respiratory Muscle Stretching for Improving Chest Expansion and Dyspnea in Post-Tuberculosis Bronchiectasis
Official title: Respiratory Muscle Stretching as an Adjunct to Pulmonary Rehabilitation: Outcomes in Chest Expansion, Dyspnea, and Cough in Post-Tuberculosis Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis Post-Tuberculosis Lung Disease
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to examine the effectiveness of adding RMS to a traditional program of pulmonary rehabilitation regarding chest expansion, dyspnea, and cough symptoms in bronchiectasis post-tuberculosis patients. Bronchiectasis, resulting from tuberculosis treatment, is characterized by restricted chest wall motility, chronic dyspnea, and an irritating cough, factors that severely impair these patients' quality of life. It is assumed that RMS improves the compliance of the chest wall, thereby enhancing respiratory mechanics and consequently reducing symptoms. The outcomes will be compared between two groups: one group with standard pulmonary rehabilitation and another group with additional RMS exercises.

Detailed description: Bronchiectasis involves the irreversible dilation and damage of the bronchi, forming an important long-term sequela in patients who have completed treatment for lung tuberculosis. This condition leads to restricted chest expansion, severe shortness of breath, and chronic cough, causing considerable distress to the affected patients' quality of life. Pulmonary rehabilitation, through aerobic exercise and breathing techniques such as Pursed Lip Breathing (PLB) and the Active Cycle of Breathing Technique (ACBT), has shown benefits in managing these symptoms. The potential additional benefit of exercises involving accessory respiratory muscles to improve chest wall mobility, using Respiratory Muscle Stretching (RMS) exercises, has not been well-explored. This single-blind randomized controlled trial will compare the effects of standard pulmonary rehabilitation alone versus standard rehabilitation combined with RMS exercises in patients with bronchiectasis post-tuberculosis. Outcomes will focus on changes in chest expansion, dyspnea, cough symptoms, and lung function parameters such as FEV1, FVC, and FEV1/FVC ratio. The study will involve 48 participants who meet the inclusion criteria and will run for four weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* History of lung TB treatment
* Clinical or radiological diagnosis of bronchiectasis
* mMRC Dyspnea Scale grade 1-3

Exclusion Criteria:

* Pneumothorax
* Pleural effusion
* COVID-19
* Lung malignancy
* Chronic obstructive pulmonary disease
* Neuromuscular disease

Primary outcomes:
measure: Chest Expansion
timeFrame: 4 weeks
Secondary outcomes:
measure: Dyspnea
timeFrame: 4 weeks
measure: Cough Symptoms
timeFrame: 4 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 4 weeks
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: 4 weeks
measure: Ratio FEV1 and FVC
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Dr. M. Goenawan Partowidigdo Lung Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Dian Marta Sari, MD., M.Sc., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: