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

Respiratory Muscle Stretching as an Adjunct to Pulmonary Rehabilitation: Outcomes in Chest Expansion, Dyspnea, and Cough in Post-Tuberculosis Bronchiectasis

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis Post-Tuberculosis Lung Disease
• Intervention / Treatment: Other: Standard PR; Other: Standard PR plus Respiratory Muscle Stretching (RMS)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bogor, West Java, Indonesia, 16750
      • Dr. M. Goenawan Partowidigdo Lung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; Group A (Standard Pulmonary Rehabilitation)	Other: Standard PR; (Aerobic exercise, PLB, ACBT, Education)
Experimental: Experimental; Group B (Standard PR + RMS)	Other: Standard PR plus Respiratory Muscle Stretching (RMS); Standard PR plus Respiratory Muscle Stretching (RMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest Expansion	Measured in centimeters at three different levels of the rib cage (upper, middle, and lower chest). An expansion of more than and equal to 3 cm is considered normal chest, and less than 3 cm is considered abnormal chest expansion in all three levels.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	Assessed using the modified Medical Research Council Dyspnea Scale (mMRC) The mMRC comprises the following four scales: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking approximately 100 meters or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.	4 weeks
Cough Symptoms	Assessed using the modified Medical Research Council Dyspnea Scale (mMRC) The mMRC comprises the following four scales: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking approximately 100 meters or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.	4 weeks
Forced Vital Capacity (FVC)	Lung function Forced Vital Capacity (FVC) is commonly assessed through spirometry and measured in liters (L) FVC: This measures the total volume of air that can be forcibly exhaled after a full inhalation. FVC values less than 80% of the predicted value are indicative of restrictive respiratory impairments, where the lungs cannot fully expand. FVC values equal to or greater than 80% are considered normal.	4 weeks
Forced Expiratory Volume in one second (FEV1)	Lung function Forced Expiratory Volume in one second (FEV1) is commonly assessed through spirometry and measured in liters (L) FEV1: This represents the air volume a person can forcefully exhale in the first second of a breath.	4 weeks
Ratio FEV1 and FVC	Lung function specifically the ratio of FEV1 and FVC (FEV1/FVC) is commonly assessed through spirometry and expressed as a percentage (%) FEV1/FVC: It is a key indicator of lung function. A normal FEV1/FVC ratio is typically greater than or equal to 70%. A ratio below this threshold suggests obstructive lung diseases, whereas a ratio above 70% but with reduced lung volumes may indicate restrictive lung diseases.	4 weeks

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Dian Marta Sari, MD., M.Sc., Ph.D, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Signs and Symptoms, Respiratory; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Lung Diseases; Tuberculosis; Dyspnea; Bronchiectasis
• Other Study ID Numbers: IKFR-202408.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No