- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509736
Effect of Pulmonary Rehabilitation in Females With Acute Exacerbation of COPD Induced by Biomass Fuel Smoke (AECOPD BIOMASS)
March 29, 2026 updated by: MarwaM, Beni-Suef University
Effect of Pulmonary Rehabilitation in Females With Acute Exacerbation of COPD Induced by Biomass Fuel Smoke Randomized Controlled Trial
COPD represents an important public health challenge that is both preventable and treatable.
GOLD is committed to improving the health of people at risk of and with COPD, wherever they happen to have been born, and wishes to do its bit to help achieve the United Nations Sustainable Development Goal to reduce premature mortality from non-communicable diseases - including COPD - by one third by 2030.
GOLD aims in stable COPD to relieve symptoms, improve exercise tolerance and improve health status.
Non-pharmacological interventions for those high-risk groups of patients, studies of intervention strategies both during inpatient stay and shortly after discharge have been undertaken, to decrease readmission rates and improve QOL, including disease-specific self-management, pulmonary rehabilitation, and early medical follow-up.Seeking for allow cost way to alleviate patients' symptoms in order to increase independence and QOL.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The study aimed to identify the effect of pulmonary rehabilitation on exercise tolerance, anxiety, depression, dyspnea and time to discharge from hospital in a group of COPD females admitted to inpatient wards till discharge from hospital.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marwa Mohammed Mohammed Eleawa, Assistant professor
- Phone Number: 01000253865
- Email: dr.marwamohammed@pt.bsu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Only females diagnosed with a history of using biomass fuel for cooking and heating during their lifetime with no history of smoking or being Ex smoker nor a non-smoker.
- Participants in clear consciousness.
- participants diagnosed with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary oedema
Exclusion Criteria:
- Systolic blood pressure lower than 90 mmHg.
- Participants with unstable psychological status, hemoptysis, pneumothorax, pulmonary edema.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Pulmonary rehabilitation group will receive In-patient interdisciplinary standardized pulmonary rehabilitation program plus the standarized medical treatment
|
Arm1: pulmonary rehabilitation group participants will perform physical therapy program and receive standardized pulmonary rehabilitation. Intervention(s): pulmonary rehabiliation program |
|
Active Comparator: Arm 2
Medical tratment group participants only receive medical treatment
|
Arm1: pulmonary rehabilitation group participants will perform physical therapy program and receive standardized pulmonary rehabilitation. Intervention(s): pulmonary rehabiliation program |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise tolerance
Time Frame: 2 months (8 weeks)
|
It measures functional capacity and exercise tolerance and it measured by 6 minutes walk test usually participants walk in 30 meters distance in the usual waling pace
|
2 months (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 20, 2026
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
June 20, 2026
Study Registration Dates
First Submitted
March 24, 2026
First Submitted That Met QC Criteria
March 29, 2026
First Posted (Actual)
April 3, 2026
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- FPT-BSU rec
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The study aimed to identify the effect of pulmonary rehabilitation on exercise tolerance, anxiety, depression, dyspnea, and time to discharge from hospital in a group of COPD females admitted to inpatient wards till discharge from hospital.
IPD Sharing Time Frame
two months
IPD Sharing Access Criteria
Participants in medical field
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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