Bronchiectasis Post-Tuberculosis Lung DiseaseNCT06722547
Respiratory Muscle Stretching Exercise for Improving Quality of Life of Patients With Bronchiectasis
A study testing Standard PR and Standard PR plus Respiratory Muscle Stretching in people with Bronchiectasis Post-Tuberculosis Lung Disease, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Bronchiectasis is a chronic condition often arising after the successful treatment of lung tuberculosis, leading to diminished functional exercise capacity, increased fatigue, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Bronchiectasis Post-Tuberculosis Lung Disease
- What is being tested?
- Standard PR and Standard PR plus Respiratory Muscle Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Jan 2024to 27 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-59 years
- History of lung TB treatment
- Clinical or radiological diagnosis of bronchiectasis
- mMRC Dyspnea Scale grade 1-3
Who cannot join
- Pneumothorax Pleural effusion
- Neuromuscular disease
- Lung malignancy
- history of COVID-19
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: The Effects of Addition Respiratory Muscle Stretching Exercise for Improving Functional Exercise Capacity Fatigue and Quality of Life in Patients With Bronchiectasis Post-Tuberculosis Lung Disease
Bronchiectasis is a chronic condition often arising after the successful treatment of lung tuberculosis, leading to diminished functional exercise capacity, increased fatigue, and reduced quality of life. This randomized controlled trial aims to evaluate the efficacy of adding Respiratory Muscle Stretching (RMS) exercises to standard pulmonary rehabilitation in improving functional exercise capacity, reducing fatigue, and enhancing the quality of life in patients with bronchiectasis post-tuberculosis.
Read the detailed description
Bronchiectasis, a long-term sequelae of lung tuberculosis, is characterized by permanent dilation and damage of the bronchi, resulting in reduced lung function, persistent fatigue, and significantly impaired quality of life. Standard pulmonary rehabilitation (PR) programs, which include aerobic exercises and breathing techniques like Pursed Lip Breathing (PLB) and the Active Cycle of Breathing Technique (ACBT), are known to offer symptomatic relief and functional improvements. However, the role of Respiratory Muscle Stretching (RMS) in this context has not been well explored.
This clinical trial will assess the impact of RMS, when combined with standard PR, on key outcomes including functional exercise capacity, fatigue, and overall quality of life in patients with bronchiectasis following tuberculosis treatment. The study will involve a parallel assignment of patients to either the standard PR group or the PR plus RMS group, with outcomes measured over a 6-week intervention period. The primary endpoints will include changes in 6-Minute Walk Test (6MWT) distances, Fatigue Severity Scale (FSS) scores, and Quality of Life (St. George's Respiratory Questionnaire) scores.
- Being tested
- Standard PR, Standard PR plus Respiratory Muscle Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PROther
PLB, ACBT, Aerobic exercise, Education
Standard PR plus Respiratory Muscle StretchingOther
Standard PR plus Respiratory Muscle Stretching (RMS)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Standard Pulmonary Rehabilitation) | Active comparator | Aerobic exercise, PLB, ACBT, Education Receives: Other: Standard PR |
| Group B (Standard PR + RMS) | Experimental | Standard PR plus Respiratory Muscle Stretching Receives: Other: Standard PR plus Respiratory Muscle Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Exercise Capacity (6-Minute Walk Test)
The 6-Minute Walk Test (6MWT) is a simple, objective, and widely used assessment tool to evaluate an individual's functional exercise capacity. It measures the total distance a person can walk in six minutes on a flat, hard surface at their own pace, serving as an indicator of aerobic capacity and endurance. This test is particularly useful in patients with chronic respiratory or cardiovascular conditions as it reflects their ability to perform daily physical activities. Prior to the test, baseline measurements of blood pressure, heart rate, oxygen saturation, and dyspnea (using the Borg Dyspnea Scale) are recorded. During the test, participants are encouraged with standardized verbal prompts while allowed to rest if needed. The primary outcome is the total distance walked, with additional observations such as pauses, walking speed, and symptoms documented. The 6MWT easy to administer, and provides valuable insights into a patient's functional status, treatment efficacy, and prognosis
Measured: 6 weeks
Secondary outcomes (2)
Fatigue (Fatigue Severity Scale)
Fatigue, a common symptom in chronic conditions, is characterized by a subjective sense of physical and mental exhaustion that can interfere with daily functioning. The Fatigue Severity Scale (FSS) is a validated self-reported questionnaire designed to assess the impact of fatigue on a person's ability to perform routine activities. Comprising nine items, the FSS measures the severity of fatigue experienced over the past week, with responses ranging from 1 (strong disagreement) to 7 (strong agreement). A higher mean score indicates greater fatigue severity. The FSS is widely used in clinical and research settings for its reliability and ability to distinguish fatigue levels in patients with various conditions, including respiratory diseases, neurological disorders, and autoimmune diseases. It provides valuable insights into the extent of fatigue, helping guide interventions and monitor treatment outcomes.
Measured: 6 weeks
Quality of Life (St. George's Respiratory Questionnaire)
The St. George's Respiratory Questionnaire (SGRQ) is a validated self-administered tool designed to assess health-related quality of life in patients with respiratory diseases. It consists of 50 items divided into three domains: Symptoms (frequency and severity of respiratory symptoms), Activity (activities limited by breathlessness), and Impacts (effects of the disease on daily life, including emotional aspects). Each domain and the total score range from 0 to 100, with higher scores indicating poorer health-related quality of life. The SGRQ provides a comprehensive evaluation of a patient's perception of their respiratory health, making it a valuable instrument for clinical trials, disease monitoring, and evaluating treatment outcomes. It has been translated into various languages, including Indonesian, ensuring reliability and validity across diverse populations.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start17 Jan 2024
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 50 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
- NCT06722547
- Sponsor's protocol ID
- IKFR-202411.04
- Status last verified
- Feb 2025
- First submitted
- 3 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allwood BW, Byrne A, Meghji J, Rachow A, van der Zalm MM, Schoch OD. Post-Tuberculosis Lung Disease: Clinical Review of an Under-Recognised Global Challenge. Respiration. 2021;100(8):751-763. doi: 10.1159/000512531. Epub 2021 Jan 5.
PubMed 33401266O'Leary CJ, Wilson CB, Hansell DM, Cole PJ, Wilson R, Jones PW. Relationship between psychological well-being and lung health status in patients with bronchiectasis. Respir Med. 2002 Sep;96(9):686-92. doi: 10.1053/rmed.2002.1330.
PubMed 12243314Sami R, Zohal M, Mohammadi N. Clinical Determinants of the Six-Minute Walk Test (6MWT) in Stable Non-Cystic Fibrosis Bronchiectasis Patients. Tanaffos. 2020 Dec;19(4):385-391.
PubMed 33959177Khosa C, Bhatt N, Massango I, Azam K, Saathoff E, Bakuli A, Riess F, Ivanova O, Hoelscher M, Rachow A. Development of chronic lung impairment in Mozambican TB patients and associated risks. BMC Pulm Med. 2020 May 7;20(1):127. doi: 10.1186/s12890-020-1167-1.
PubMed 32381002
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
- The Effects of Addition Respiratory Muscle Stretching Exercise for Improving Functional Exercise Capacity Fatigue and Quality of Life in Patients With Bronchiectasis Post-Tuberculosis Lung Disease
- ClinicalTrials.gov ID
- NCT06722547
- Acronym / sponsor ID
- IKFR-202411.04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 9 Dec 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.
Bronchiectasis is a chronic condition often arising after the successful treatment of lung tuberculosis, leading to diminished functional exercise capacity, increased fatigue, and reduced quality of life. This randomized controlled trial aims to evaluate the efficacy of adding Respiratory Muscle Stretching (RMS) exercises to standard pulmonary rehabilitation in improving functional exercise capacity, reducing fatigue, and enhancing the quality of life in patients with bronchiectasis post-tuberculosis.
Detailed description
Bronchiectasis, a long-term sequelae of lung tuberculosis, is characterized by permanent dilation and damage of the bronchi, resulting in reduced lung function, persistent fatigue, and significantly impaired quality of life. Standard pulmonary rehabilitation (PR) programs, which include aerobic exercises and breathing techniques like Pursed Lip Breathing (PLB) and the Active Cycle of Breathing Technique (ACBT), are known to offer symptomatic relief and functional improvements. However, the role of Respiratory Muscle Stretching (RMS) in this context has not been well explored.
This clinical trial will assess the impact of RMS, when combined with standard PR, on key outcomes including functional exercise capacity, fatigue, and overall quality of life in patients with bronchiectasis following tuberculosis treatment. The study will involve a parallel assignment of patients to either the standard PR group or the PR plus RMS group, with outcomes measured over a 6-week intervention period. The primary endpoints will include changes in 6-Minute Walk Test (6MWT) distances, Fatigue Severity Scale (FSS) scores, and Quality of Life (St. George's Respiratory Questionnaire) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Standard Pulmonary Rehabilitation) | Active comparator | Other: Standard PRAerobic exercise, PLB, ACBT, Education |
| Group B (Standard PR + RMS) | Experimental | Other: Standard PR plus Respiratory Muscle StretchingStandard PR plus Respiratory Muscle Stretching |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-59 years
- History of lung TB treatment
- Clinical or radiological diagnosis of bronchiectasis
- mMRC Dyspnea Scale grade 1-3
Key exclusion criteria (4 listed)
- Pneumothorax Pleural effusion
- Neuromuscular disease
- Lung malignancy
- history of COVID-19
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 PRPLB, ACBT, Aerobic exercise, Education | Other | Group A (Standard Pulmonary Rehabilitation) |
| Standard PR plus Respiratory Muscle StretchingStandard PR plus Respiratory Muscle Stretching (RMS) | Other | Group B (Standard PR + RMS) |
Primary outcome
Functional Exercise Capacity (6-Minute Walk Test)
Time frame: 6 weeks
The 6-Minute Walk Test (6MWT) is a simple, objective, and widely used assessment tool to evaluate an individual's functional exercise capacity. It measures the total distance a person can walk in six minutes on a flat, hard surface at their own pace, serving as an indicator of aerobic capacity and endurance. This test is particularly useful in patients with chronic respiratory or cardiovascular conditions as it reflects their ability to perform daily physical activities. Prior to the test, baseline measurements of blood pressure, heart rate, oxygen saturation, and dyspnea (using the Borg Dyspnea Scale) are recorded. During the test, participants are encouraged with standardized verbal prompts while allowed to rest if needed. The primary outcome is the total distance walked, with additional observations such as pauses, walking speed, and symptoms documented. The 6MWT easy to administer, and provides valuable insights into a patient's functional status, treatment efficacy, and prognosis
2 secondary outcomes
Fatigue (Fatigue Severity Scale)
Time frame: 6 weeks
Quality of Life (St. George's Respiratory Questionnaire)
Time frame: 6 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.
- Background: PubMed 33401266Allwood BW, Byrne A, Meghji J, Rachow A, van der Zalm MM, Schoch OD. Post-Tuberculosis Lung Disease: Clinical Review of an Under-Recognised Global Challenge. Respiration. 2021;100(8):751-763. doi: 10.1159/000512531. Epub 2021 Jan 5.
- Background: PubMed 12243314O'Leary CJ, Wilson CB, Hansell DM, Cole PJ, Wilson R, Jones PW. Relationship between psychological well-being and lung health status in patients with bronchiectasis. Respir Med. 2002 Sep;96(9):686-92. doi: 10.1053/rmed.2002.1330.
- Background: PubMed 33959177Sami R, Zohal M, Mohammadi N. Clinical Determinants of the Six-Minute Walk Test (6MWT) in Stable Non-Cystic Fibrosis Bronchiectasis Patients. Tanaffos. 2020 Dec;19(4):385-391.
- Background: PubMed 32381002Khosa C, Bhatt N, Massango I, Azam K, Saathoff E, Bakuli A, Riess F, Ivanova O, Hoelscher M, Rachow A. Development of chronic lung impairment in Mozambican TB patients and associated risks. BMC Pulm Med. 2020 May 7;20(1):127. doi: 10.1186/s12890-020-1167-1.
- Individual participant dataSharing planned: No
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 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 4 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?
Functional Exercise Capacity (6-Minute Walk Test) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722547, which also lists 4 linked publications.
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; AzTrials last refreshed its copy on 8 Nov 2026.