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

NCT07484490 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/NAYAB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tuberculosis

Keywords

Sputum secretion; Dyspnea; Functional Capacity; Balloon blowing therapy; Active cycle of breathing

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Other: Active Cycle of breathing

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

Other: Active cycle of breathing with Balloon therapy

Interventions

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 technique

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

Active cycle of breathing technique with balloon blowing therapy

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, 54000, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 37440814 BACKGROUND

• 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.

  PMID: 39630726 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Dyspnea

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nayab shahid, MS-PT

  RIPHAH INTERNATINAAL UNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; IMRAN.AMJAD@RIPHAH.EDU.PK

MUHAMMAD ASIF JAVEED, MS-PT

CONTACT

9233224209422; a.javeed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)