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NCT Number: NCT07484490

Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in 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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Hospital

Lahore, 54000, Pakistan

Location status: Recruiting

Location contact

Mashar Hayat, MS-PT

CONTACT

03338264018

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Active cycle of breathing with Balloon therapy

Other

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 breathing

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

MUHAMMAD ASIF JAVEED, MS-PT

CONTACT

[email protected]

9233224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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