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

February 23, 2025 updated by: Universitas Padjadjaran

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chest Expansion
Time Frame: 4 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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)
Time Frame: 4 weeks

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)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Padjadjaran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dian Marta Sari, MD., M.Sc., Ph.D, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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