An interventional study of Active cycle of breathing with Balloon therapy and Active Cycle of breathing in Tuberculosis, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Riphah International University · Not applicable, Interventional, and Other
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.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 34 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(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
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. 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
Other: Active Cycle of breathing
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
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
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
Time frame: 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.
Time frame: 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.
Time frame: Baeline,3day
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's planned 8 months is below that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
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