NCT07477080

Brief Summary

The goal for this clinical trial was to compare the effectiveness of Diaphragmatic Breathing and Pursed-Lip Expiration Exercises in improving lung functions {the Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1- second (FEV1)} and Chest Expansion in Egyptian outpatient adults with bronchial asthma. The research questions were:

  1. 1.Are Diaphragmatic Breathing Exercises effective in improving lung function parameters?
  2. 2.Are Pursed-Lip Expiration Exercises effective in improving lung function parameters?
  3. 3.Which of the two studied breathing exercise is more effective in improving lung function parameters?
  4. 4.Lung functions {Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1-second (FEV1)}
  5. 5.The chest expansion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 9, 2026

Last Update Submit

March 13, 2026

Conditions

Asthma Chronic

Keywords

diaphragmatic breathing exercisepursed lip expiration exerciseasthmabreathing exercisespulmonary functions

Outcome Measures

Primary Outcomes (3)

  • Changes in FEV1

    Changes in FEV1 were compared within each group before and after intervention by the breathing exercises and between the two groups

    8 weeks

  • Changes in PEFR

    Changes in PEFR were compared within each group before and after intervention by the breathing exercises and between the two groups

    8 WEEKS

  • Changes in chest expansion

    Changes in chest expansion were compared within each group before and after intervention by the breathing exercises and between the two groups

    8 weeks

Study Arms (2)

Diaphragmatic Breathing Exercise

EXPERIMENTAL

Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week). Relaxation and comfortable positioning of the participant with full support to back and head and relaxation of the abdominal wall (fowler's position). One hand of the participant placed on the rectus abdominis muscle just inferior to the anterior costal margin and the other hand on chest wall keeping the shoulders relaxed and upper chest quiet during breathing in slowly and deeply through the nose following the abdomen to rise with subsequent slow expiration through pursed lip for three or four times then rest. Three or four sets were applied in 20 minutes exercising session.

Behavioral: diaphragmatic breathing exercise

pursed lip breathing exercise group

EXPERIMENTAL

Pursed-Lip Expiration Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week). Closing the mouth while breathing in slowly through the nose for two counts while keeping shoulders and neck relaxed followed by expiration using pursued lips (as if they mimic whistling) for four counts. Three or four sets were applied in 20 minutes exercising session.

Behavioral: pursed lip breathing exercise

Interventions

diaphragmatic breathing exerciseBEHAVIORAL

Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week). Relaxation and comfortable positioning of the participant with full support to back and head and relaxation of the abdominal wall (fowler's position). One hand of the participant placed on the rectus abdominis muscle just inferior to the anterior costal margin and the other hand on chest wall keeping the shoulders relaxed and upper chest quiet during breathing in slowly and deeply through the nose following the abdomen to rise with subsequent slow expiration through pursed lip for three or four times then rest. Three or four sets were applied in 20 minutes exercising session.

Diaphragmatic Breathing Exercise
pursed lip breathing exerciseBEHAVIORAL

Pursed-Lip Expiration Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week). Closing the mouth while breathing in slowly through the nose for two counts while keeping shoulders and neck relaxed followed by expiration using pursued lips (as if they mimic whistling) for four counts. Three or four sets were applied in 20 minutes exercising session.

pursed lip breathing exercise group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Egyptian adults aged between 18 and 60 years old, both males and females.
  • Pulmonary function-based diagnosis for asthma.
  • Mild and moderate cases of asthma.

You may not qualify if:

  • Recent myocardial infarction or acute coronary syndrome.
  • Non-cooperative patients.
  • Status asthmatics patients.
  • Hypoxic patients.
  • Asthmatic patients who were associated with other chest and heart diseases.
  • Recent pneumothorax or pulmonary embolism.
  • Large thoracic or abdominal aortic aneurysm.
  • Acute onset of hemoptysis.
  • Retinal detachment.
  • Intracranial hypertension.
  • Patients with dementia.
  • Recent brain, eye, ear, nose, abdominal or thoracic surgery.
  • Severe uncontrolled hypertension.
  • Patients with urinary incontinence.
  • Currently admitted to intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasya, Egypt

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wafaa M Qurany, Master,Family medicine

    Ain Shams University,Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Mohamed F Allam, MD, Professor

    Ain Shams University,Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: arm 1: Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week). arm 2: Pursed-Lip Expiration Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer in family medicine department ,faculty of medicine

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 17, 2026

Study Start

October 15, 2022

Primary Completion

March 13, 2024

Study Completion

March 13, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)