NCT07717476

Brief Summary

Asthma is a chronic respiratory disease that can cause breathing difficulties, reduced lung function, and poor sleep quality. Breathing exercises are increasingly used as non-pharmacological interventions to improve respiratory symptoms and overall well-being in individuals with asthma. This study aims to compare the effects of two breathing techniques, Box Breathing and Rhythmic Breathing, on dyspnea (breathlessness), pulmonary function, and quality of sleep in patients with asthma. Participants with asthma will be randomly assigned to receive either Box Breathing or Rhythmic Breathing exercises in addition to standard care. Both interventions will be performed three times per week for eight weeks. The primary outcomes of this study include changes in dyspnea severity, pulmonary function measured by spirometry, and sleep quality assessed using validated questionnaires. The findings of this study may help determine which breathing technique is more effective and provide evidence for incorporating structured breathing exercises into asthma management programs.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 17, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

AsthmaBox BreathingRhythmic Breathing

Outcome Measures

Primary Outcomes (1)

  • Dyspnea Severity

    Dyspnea severity will be assessed using the Modified Borg Scale, a numerical rating scale ranging from 0 to 10, where higher scores indicate greater perceived breathlessness.

    Baseline and 8 weeks (post-intervention)

Secondary Outcomes (2)

  • Pulmonary Function (Forced Expiratory Volume in 1 Second [FEV₁])

    Baseline and 8 weeks (post-intervention)

  • Sleep Quality

    Baseline and 8 weeks (post-intervention)

Study Arms (2)

Box Breathing Group A

EXPERIMENTAL

Participants assigned to this arm received standardized baseline respiratory care followed by Box Breathing training. The Box Breathing technique consisted of inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath again for 4 seconds. The intervention was performed for 20 minutes per session, three sessions per week, for eight weeks. Short rest periods were provided as needed during the intervention.

Behavioral: Box Breathing

Rhythmic Breathing Group

EXPERIMENTAL

Participants assigned to this arm received standardized baseline respiratory care followed by Rhythmic Breathing training. The Rhythmic Breathing technique consisted of a controlled breathing pattern using a 4:6 ratio, with inhalation through the nose for 4 seconds and exhalation through the mouth for 6 seconds. The intervention was performed for 20 minutes per session, three sessions per week, for eight weeks. Short rest periods were provided as needed during the intervention.

Behavioral: Rhythmic Breathing

Interventions

Box BreathingBEHAVIORAL

Participants assigned to the Box Breathing intervention received a structured breathing exercise protocol following standardized baseline respiratory care. The Box Breathing technique consisted of inhalation for 4 seconds, breath holding for 4 seconds, exhalation for 4 seconds, and a second breath hold for 4 seconds (4-4-4-4 pattern). The intervention was administered for 20 minutes per session, three sessions per week, for eight weeks. Short rest periods were permitted after every 5-6 breathing cycles as needed. The intervention was performed in a quiet environment and aimed to improve respiratory control, reduce dyspnea, enhance ventilatory efficiency, and promote autonomic regulation.

Box Breathing Group A

Participants assigned to the Rhythmic Breathing intervention received a structured breathing exercise protocol following standardized baseline respiratory care. The Rhythmic Breathing technique consisted of a controlled breathing pattern using a 4:6 ratio, with inhalation through the nose for 4 seconds and exhalation through the mouth for 6 seconds. The intervention was administered for 20 minutes per session, three sessions per week, for eight weeks. Short rest periods were provided every 6-7 minutes as needed. The intervention was designed to promote respiratory efficiency, improve autonomic balance, reduce dyspnea, and enhance pulmonary function and sleep quality.

Rhythmic Breathing Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients diagnosed with asthma.
  • Age between 18 and 40 years.
  • Patients with mild to moderate asthma who are clinically stable.
  • Patients able to understand and follow breathing exercise instructions.
  • Patients willing to provide informed consent and participate in the study.

You may not qualify if:

  • Patients with severe or uncontrolled asthma.
  • Patients with acute asthma exacerbation during the study period.
  • Patients with other significant respiratory diseases (e.g., chronic obstructive pulmonary disease, pulmonary fibrosis).
  • Patients with severe cardiovascular, neurological, or musculoskeletal disorders that may interfere with participation.
  • Patients who are pregnant.
  • Patients unable to perform the breathing interventions or complete study assessments.
  • Patients participating in another structured respiratory rehabilitation or breathing exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ittefaq Hospital and Ghurki Trust Hospital

Lahore, Punjab Province, 59300, Pakistan

Location

MeSH Terms

Conditions

AsthmaDisease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Humera Ayub, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Humera Ayub, MS CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a parallel-group design to one of two intervention arms: Box Breathing or Rhythmic Breathing. Both groups received standardized baseline respiratory care followed by their assigned breathing intervention three times per week for eight weeks. Outcomes were assessed at baseline and after completion of the intervention period by a blinded assessor.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 21, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) collected during this study will not be made publicly available. The decision not to share IPD is based on the need to protect participant privacy and confidentiality, as the informed consent process did not include provisions for public data sharing. Only aggregate and de-identified study findings will be reported and published.

Locations