TuberculosisNCT07484490
Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis
A study testing Active cycle of breathing with Balloon therapy and Active Cycle of breathing in people with Tuberculosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group or a control group. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Active cycle of breathing with Balloon therapy and Active Cycle of breathing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to14 years
- Diagnosed with tuberculosis
- Patients with excessive pulmonary secretions and/or difficulty clearing airway secretions.
- Adequate cognitive ability to understand and follow verbal commands and perform ACBT.
- Informed consent from parent/guardian
Who cannot join
- Diagnosed with multi-drug-resistant (MDR) TB
- Presence of hemoptysis
- The patient who is unconscious and unresponsive.
- Received physical therapy intervention in the past 2 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital
Lahore, 54000
Mashar Hayat, MS-PT, 03338264018
About this study
Official title: Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy on Sputum Secretion, Dyspnea, and Functional Capacity in Children With Tuberculosis
The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg dyspne Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.
Read the detailed description
Pulmonary Tuberculosis (TB) is still a major health concern, especially in underdeveloped nations. Poor lung function, sputum retention, and dyspnea are common in children with tuberculosis (TB), which can limit their physical activity and quality of life. Physiotherapy treatments are essential for controlling these problems. An effective airway clearance technique that improves ventilation and mucus mobilization is the Active Cycle of Breathing Techniques (ACBT). Similarly, balloon therapy has been shown to strengthen respiratory muscles and alleviate dyspnea. Both interventions are low-cost, non-invasive, and feasible for implementation across diverse clinical and community settings. Although these therapies are successful when used separately, their combined effect on the therapy of pediatric tuberculosis has not been fully investigated. The aim of this study is to investigate the Effect of the Active cycle of breathing technique with and without balloon blowing therapy on sputum secretion, dyspnea and functional capacity in children with tuberculosis The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group (n=17) or a control group (n=17). The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.
- Conditions
- Tuberculosis
- Being tested
- Active cycle of breathing with Balloon therapy, Active Cycle of breathing
- Keywords
- Sputum secretion, Dyspnea, Functional Capacity, Balloon blowing therapy, Active cycle of breathing
- Medical subject headings
- Tuberculosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing with Balloon therapyOther
ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. • This method should be used six times. 2. Thoracic Expansion (3-5 repetitions): • During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. • (FET) is involves relaxed breathing followed by one or two "huffs" BALLOON BLOWING THERAPY: child should be upright seating. Participants will instruct to inhale deeply through the nose and exhale slowly into the balloon with straw in 30 minutes
Active Cycle of breathingOther
ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • In this stage the participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. • This method should be used six times. 2. Thoracic Expansion (3-5 repetitions): • During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. • This phase facilitates airflow and relaxes secretions. 7. The forced expiratory technique (FET) • his involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes to facilitate secretion clearance
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique with balloon blowing therapy | Experimental | (ACBT) are intended to improve ventilation by mobilizing and clearing pulmonary secretions. ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases Breathing Control (1-2 min): During this stage, the shoulders and upper chest of participants are relaxed. With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening.It is used six times. Thoracic Expansion (3-5 repetitions): During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. (FET) involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes BALLOON BLOWING THERAPY: child should be upright seating or in a semi-Fowler's position participants will instruct to inhale deeply through the nose and exhale slowly into the balloon with straw Receives: Other: Active cycle of breathing with Balloon therapy |
| Active cycle of breathing technique | Other | (ACBT) are intended to improve ventilation by mobilizing and clearing pulmonary secretions. ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases Breathing Control (1-2 min): During this stage, the shoulders and upper chest of participants are relaxed. With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. This method should be used six times. Thoracic Expansion (3-5 repetitions): During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. The forced expiratory technique (FET) involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes to facilitate secretion clearance Receives: Other: Active Cycle of breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum meauring cups
Sputum volume, the main outcome measure, will measured 24 hours before each treatment.
The patients were requested to keep a sputum journal, and the calibrated sputum cups will be used to record the volume of sputum. The total amount of sputum produced over a 24-hour period was noted
Measured: Baeline,3day
6 minute walk test (6-MWT)
The test is carried out in an inside hallway with colorful tape on the floor marking a 100-foot distance in accordance with a regular procedure. The test's objective was to determine how far the volunteers could walk in six minutes, they were informed. Then, for the next six minutes, they were told to cover as much territory as they could by moving up and down the hallway.
The subject could take breaks if they wanted to, and the test was self-paced.
Measured: baseline,3day
Modified Borg Dyspnea Scale
The Modified Borg Dyspnea Scale (MBS), a numerical score with a range of 0 to 10, is frequently one of the most often used metrics to evaluate the severity dyspnea . This vertical scale, which ranges from 0 to 10, provides a personal assessment of exercise intensity. 0 denotes no symptoms, while 10 denotes the highest level of symptoms.
Measured: Baeline,3day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start29 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group (or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg dyspnea Scale," and functional capacity will be measured by the "6-Minute Walk Test." The aim of this study is to Provide interventions that are low-cost, non-invasive, and feasible for implementation across diverse clinical and community settings .Data will be analyzed through SPSS version 25.0.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayab shahid, MS-PT, Principal investigator, RIPHAH INTERNATINAAL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484490
- Sponsor's protocol ID
- REC/RCR&AHS/25/0732
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misra A, Pawar R, Pal A. Effect of Balloon-Blowing Exercise on Oxygen Saturation in COVID-19 Patients. Cureus. 2023 Jun 11;15(6):e40250. doi: 10.7759/cureus.40250. eCollection 2023 Jun.
PubMed 37440814Aytac S, Ovayolu O, Dogru S. The effect of breathing exercises on fatigue in tuberculosis patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2024 Dec 2;70(12):e20240888. doi: 10.1590/1806-9282.20240888. eCollection 2024.
PubMed 39630726
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy on Sputum Secretion, Dyspnea, and Functional Capacity in Children With Tuberculosis
- ClinicalTrials.gov ID
- NCT07484490
- Acronym / sponsor ID
- REC/RCR&AHS/25/0732
- Conditions
- Tuberculosis
- Keywords
- Sputum secretion, Dyspnea, Functional Capacity, Balloon blowing therapy, Active cycle of breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg dyspne Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.
Detailed description
Pulmonary Tuberculosis (TB) is still a major health concern, especially in underdeveloped nations. Poor lung function, sputum retention, and dyspnea are common in children with tuberculosis (TB), which can limit their physical activity and quality of life. Physiotherapy treatments are essential for controlling these problems. An effective airway clearance technique that improves ventilation and mucus mobilization is the Active Cycle of Breathing Techniques (ACBT). Similarly, balloon therapy has been shown to strengthen respiratory muscles and alleviate dyspnea. Both interventions are low-cost, non-invasive, and feasible for implementation across diverse clinical and community settings. Although these therapies are successful when used separately, their combined effect on the therapy of pediatric tuberculosis has not been fully investigated. The aim of this study is to investigate the Effect of the Active cycle of breathing technique with and without balloon blowing therapy on sputum secretion, dyspnea and functional capacity in children with tuberculosis The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group (n=17) or a control group (n=17). The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group (or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg dyspnea Scale," and functional capacity will be measured by the "6-Minute Walk Test." The aim of this study is to Provide interventions that are low-cost, non-invasive, and feasible for implementation across diverse clinical and community settings .Data will be analyzed through SPSS version 25.0.
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique with balloon blowing therapy | Experimental | Other: Active cycle of breathing with Balloon therapy(ACBT) are intended to improve ventilation by mobilizing and clearing pulmonary secretions. ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases Breathing Control (1-2 min): During this stage, the shoulders and upper chest of participants are relaxed. With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening.It is used six times. Thoracic Expansion (3-5 repetitions): During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. (FET) involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes BALLOON BLOWING THERAPY: child should be upright seating or in a semi-Fowler's position participants will instruct to inhale deeply through the nose and exhale slowly into the balloon with straw |
| Active cycle of breathing technique | Other | Other: Active Cycle of breathing(ACBT) are intended to improve ventilation by mobilizing and clearing pulmonary secretions. ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases Breathing Control (1-2 min): During this stage, the shoulders and upper chest of participants are relaxed. With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. This method should be used six times. Thoracic Expansion (3-5 repetitions): During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. The forced expiratory technique (FET) involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes to facilitate secretion clearance |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 8 to14 years
- Diagnosed with tuberculosis
- Patients with excessive pulmonary secretions and/or difficulty clearing airway secretions.
- Adequate cognitive ability to understand and follow verbal commands and perform ACBT.
- Informed consent from parent/guardian
Key exclusion criteria (4 listed)
- Diagnosed with multi-drug-resistant (MDR) TB
- Presence of hemoptysis
- The patient who is unconscious and unresponsive.
- Received physical therapy intervention in the past 2 weeks
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 |
|---|---|---|
| Active cycle of breathing with Balloon therapyACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. • This method should be used six times. 2. Thoracic Expansion (3-5 repetitions): • During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. • (FET) is involves relaxed breathing followed by one or two "huffs" BALLOON BLOWING THERAPY: child should be upright seating. Participants will instruct to inhale deeply through the nose and exhale slowly into the balloon with straw in 30 minutes | Other | Active cycle of breathing technique with balloon blowing therapy |
| Active Cycle of breathingACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • In this stage the participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral opening. • This method should be used six times. 2. Thoracic Expansion (3-5 repetitions): • During this phase, the patient inhales through their nose, holds it for two to three seconds, and then exhales. • This phase facilitates airflow and relaxes secretions. 7. The forced expiratory technique (FET) • his involves relaxed breathing followed by one or two "huffs" from mid to low lung volumes to facilitate secretion clearance | Other | Active cycle of breathing technique |
Primary outcome
Sputum meauring cups
Time frame: Baeline,3day
Sputum volume, the main outcome measure, will measured 24 hours before each treatment. The patients were requested to keep a sputum journal, and the calibrated sputum cups will be used to record the volume of sputum. The total amount of sputum produced over a 24-hour period was noted
6 minute walk test (6-MWT)
Time frame: baseline,3day
The test is carried out in an inside hallway with colorful tape on the floor marking a 100-foot distance in accordance with a regular procedure. The test's objective was to determine how far the volunteers could walk in six minutes, they were informed. Then, for the next six minutes, they were told to cover as much territory as they could by moving up and down the hallway. The subject could take breaks if they wanted to, and the test was self-paced.
Modified Borg Dyspnea Scale
Time frame: Baeline,3day
The Modified Borg Dyspnea Scale (MBS), a numerical score with a range of 0 to 10, is frequently one of the most often used metrics to evaluate the severity dyspnea . This vertical scale, which ranges from 0 to 10, provides a personal assessment of exercise intensity. 0 denotes no symptoms, while 10 denotes the highest level of symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 37440814Misra A, Pawar R, Pal A. Effect of Balloon-Blowing Exercise on Oxygen Saturation in COVID-19 Patients. Cureus. 2023 Jun 11;15(6):e40250. doi: 10.7759/cureus.40250. eCollection 2023 Jun.
- Background: PubMed 39630726Aytac S, Ovayolu O, Dogru S. The effect of breathing exercises on fatigue in tuberculosis patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2024 Dec 2;70(12):e20240888. doi: 10.1590/1806-9282.20240888. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Nayab shahid, MS-PT principal investigator
RIPHAH INTERNATINAAL UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing with Balloon therapy and Active Cycle of breathing in people with Tuberculosis, run by Riphah International University at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, IMRAN.AMJAD@RIPHAH.EDU.PK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum meauring cups (time frame: Baeline,3day). The study lists 3 primary outcomes in all. 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 NCT07484490, which also lists 2 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 12 Aug 2026.