Bronchiectasis Post-Tuberculosis Lung DiseaseNCT06597409
Respiratory Muscle Stretching for Improving Chest Expansion and Dyspnea in Post-Tuberculosis Bronchiectasis
A study testing Standard PR and Standard PR plus Respiratory Muscle Stretching (RMS) in people with Bronchiectasis Post-Tuberculosis Lung Disease, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchiectasis Post-Tuberculosis Lung Disease
- What is being tested?
- Standard PR and Standard PR plus Respiratory Muscle Stretching (RMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Apr 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- History of lung TB treatment
- Clinical or radiological diagnosis of bronchiectasis
- mMRC Dyspnea Scale grade 1-3
Who cannot join
- Pneumothorax
- Pleural effusion
- COVID-19
- Lung malignancy
- Chronic obstructive pulmonary disease
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. M. Goenawan Partowidigdo Lung Hospital
Bogor, West Java, 16750
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard PR, Standard PR plus Respiratory Muscle Stretching (RMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PROther
(Aerobic exercise, PLB, ACBT, Education)
Standard PR plus Respiratory Muscle Stretching (RMS)Other
Standard PR plus Respiratory Muscle Stretching (RMS)
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Group A (Standard Pulmonary Rehabilitation) Receives: Other: Standard PR |
| Experimental | Experimental | Group B (Standard PR + RMS) Receives: Other: Standard PR plus Respiratory Muscle Stretching (RMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Apr 2024
- Primary completion18 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis Post-Tuberculosis Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dian Marta Sari, MD., M.Sc., Ph.D, Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597409
- Sponsor's protocol ID
- IKFR-202408.03
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Stretching as an Adjunct to Pulmonary Rehabilitation: Outcomes in Chest Expansion, Dyspnea, and Cough in Post-Tuberculosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT06597409
- Acronym / sponsor ID
- IKFR-202408.03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Standard PRGroup A (Standard Pulmonary Rehabilitation) |
| Experimental | Experimental | Other: Standard PR plus Respiratory Muscle Stretching (RMS)Group B (Standard PR + RMS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- History of lung TB treatment
- Clinical or radiological diagnosis of bronchiectasis
- mMRC Dyspnea Scale grade 1-3
Key exclusion criteria (6 listed)
- Pneumothorax
- Pleural effusion
- COVID-19
- Lung malignancy
- Chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard PR(Aerobic exercise, PLB, ACBT, Education) | Other | Active Comparator |
| Standard PR plus Respiratory Muscle Stretching (RMS)Standard PR plus Respiratory Muscle Stretching (RMS) | Other | Experimental |
Primary outcome
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.
5 secondary outcomes
Dyspnea
Time frame: 4 weeks
Cough Symptoms
Time frame: 4 weeks
Forced Vital Capacity (FVC)
Time frame: 4 weeks
Forced Expiratory Volume in one second (FEV1)
Time frame: 4 weeks
Ratio FEV1 and FVC
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
Related trials for Bronchiectasis Post-Tuberculosis Lung Disease
Not yet recruiting
The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.
Post Pulmonary Tuberculosis, Post-Tuberculous Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dian Marta Sari, MD., M.Sc., Ph.D principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PR and Standard PR plus Respiratory Muscle Stretching (RMS) in people with Bronchiectasis Post-Tuberculosis Lung Disease, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Expansion (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.