Respiratory Muscle Stretching for Improving Chest Expansion and Dyspnea in Post-Tuberculosis Bronchiectasis

NCT ID: NCT06597409

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2025-01-31

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.

Conditions

Bronchiectasis Post-Tuberculosis Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Comparator

Group A (Standard Pulmonary Rehabilitation)

Group Type: ACTIVE_COMPARATOR

Standard PR

Intervention Type: OTHER

(Aerobic exercise, PLB, ACBT, Education)

Experimental

Group B (Standard PR + RMS)

Group Type: EXPERIMENTAL

Standard PR plus Respiratory Muscle Stretching (RMS)

Intervention Type: OTHER

Standard PR plus Respiratory Muscle Stretching (RMS)

Interventions

Standard PR

(Aerobic exercise, PLB, ACBT, Education)

Intervention Type: OTHER

Standard PR plus Respiratory Muscle Stretching (RMS)

Standard PR plus Respiratory Muscle Stretching (RMS)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dian Marta Sari, MD., M.Sc., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Dr. M. Goenawan Partowidigdo Lung Hospital

Bogor, West Java, Indonesia

Countries

Indonesia

Other Identifiers

IKFR-202408.03

Identifier Type: -

Identifier Source: org_study_id