NCT06472167

Brief Summary

aim of this study is to evaluate the efficacy of pulmonary rehabilitation program as a non-pharmacological treatment method to: Improve functional capacity as assessed by six-minute walking distance (6MWD) test. Improve dyspnea level as assessed by Medical Research Council (MRC) dyspnea scale. Improve pulmonary function tests and arterial blood gas.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

June 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

June 13, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

Breathing exerciseslung functionChronic airway diseases

Outcome Measures

Primary Outcomes (2)

  • Impact of breathing exercises on Forced expiratory volume on first second (FEV1) in liter

    Effect of Breathing exercises on lung function using spirometry

    6 months

  • Impact of breathing exercises on Forced vital capacity (FVC) in liter

    Effect of Breathing exercises on lung function using spirometry

    6 months

Study Arms (2)

Chronic airway diseases treated by medication

NO INTERVENTION

Chronic airway diseases treated by medication without breathing exercises

Chronic airway diseases treated by medication with breathing exercises

ACTIVE COMPARATOR

Chronic airway diseases treated by medication and breathing exercises

Behavioral: Breathing exercises

Interventions

Breathing exercises as diaphragmatic breathing exercises and pursued lip breathing and incentive spirometry

Also known as: Diaphragmatic Breathing exercise, Pursued lip breathing
Chronic airway diseases treated by medication with breathing exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients fulfilled the criteria for COPD: the presence of a post bronchodilator FEV1 \< 80% predicated together with an FEV1/FVC \<0.70confirm the presence of airflow limitation that is not fully reversible.
  • COPD patients ranging from mild to severe according to GOLD \[stages I-IV\].
  • Asthmatic patients receive medical treatment for at least 6 months; and clinically stable (i.e., no exacerbation or changes in medication for ≥30 days).
  • None of the individuals had been engaged in any exercise-training program before participating in the study.
  • Optimized medical therapy according to GOLD \& Global Initiative for Asthma (GINA)
  • Clinically stable COPD and asthmatic patients (not suffering from a recent respiratory tract infection).
  • All patients are Ex-smoker

You may not qualify if:

  • Age \<18 years.
  • Pregnancy
  • Current Smokers
  • Patients that are incapable of exercising; unable to understand any questionnaire
  • Multiple co- morbidity (e.g., cardiovascular diseases, active cancer)
  • Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
  • Diaphragmatic Paralysis (paralyzed diaphragm exhibiting abnormal paradoxical movement, i.e., moving in a cranial direction during inspiration).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Mohamed AbdElmoniem

    Lecturer of chest medicine faculty of medicine Mansoura university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AbdElmoniem

CONTACT

Mohamed Ahmed Ibrahim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest medicine

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 25, 2024

Study Start

June 1, 2024

Primary Completion

August 10, 2025

Study Completion

December 10, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations