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

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Active Cycle of breathing; Other: Active cycle of breathing with Balloon therapy

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IMRAN AMJAD, PhD; Phone Number: 9233224390125; Email: imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: MUHAMMAD ASIF JAVEED, MS-PT; Phone Number: 9233224209422; Email: a.javeed@riphah.edu.pk

Study Locations

• Pakistan
  • Lahore, Pakistan, 54000
    • Recruiting
    • Gulab Devi Hospital
    • Contact: Mashar Hayat, MS-PT; Phone Number: 03338264018

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Children aged 8 to14 years
2. Diagnosed with tuberculosis
3. Patients with excessive pulmonary secretions and/or difficulty clearing airway secretions.
4. Adequate cognitive ability to understand and follow verbal commands and perform ACBT.
5. Informed consent from parent/guardian

Exclusion Criteria:

1. Diagnosed with multi-drug-resistant (MDR) TB
2. Presence of hemoptysis
3. The patient who is unconscious and unresponsive.
4. Received physical therapy intervention in the past 2 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active cycle of breathing technique with balloon blowing 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	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): • 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; (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 with Balloon therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Baeline,3day

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Nayab shahid, MS-PT, RIPHAH INTERNATINAAL UNIVERSITY

Publications and helpful links

General 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.
• Aytac 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. Erratum In: Rev Assoc Med Bras (1992). 2025 Jan 20;71(1):e20240888ERRATUM. doi: 10.1590/1806-9282.20240888ERRATUM.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dyspnea; Functional Capacity; Sputum secretion; Balloon blowing therapy; Active cycle of breathing
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tuberculosis; Dyspnea
• Other Study ID Numbers: REC/RCR&AHS/NAYAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No