- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446985
Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma?
February 26, 2026 updated by: Ali Mohamed Ali ismail, Cairo University
Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma.
Nowdays, diet restriction combimed with phsyical exercises may improve both problems
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Forty Women with asthma with PCOS will be enrolled to be catogrized to Group I or group II.
Group I will enroll twenty females with PCOS and asthma who will apply forty minutes walking on treadmill three times per week.
Also Group I will follow low calorie diet and daily metformin for 12 weeks.
Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks
Study Type
Interventional
Enrollment (Estimated)
40
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: Ali MA Ismail, lecturer
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: ali mohamed
- Phone Number: 0201031321109
- Email: fatmaraed1994@gmail.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Cairo University
-
Contact:
- ali ismail, lecturer
- Phone Number: 02 01005154209
- Email: ali.mohamed@pt.cu.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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- PCOS women
- women with asthma
- obese women (calss I)
Exclusion Criteria:
- cardiac problems
- renal problems
- liver problems
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group number 1
Group I will enroll twenty females with PCOS and asthma who will apply forty minutes walking on treadmill three times per week.
Also Group I will follow low calorie diet and daily metformin for 12 weeks.
|
Group I will enroll twenty females with PCOS and asthma who will apply forty minutes walking on treadmill three times per week.
Also Group I will follow low calorie diet and daily metformin for 12 weeks.
|
|
Active Comparator: group number 2
Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks
|
Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced vital capcity
Time Frame: it will be measured after 12 weeks
|
it is a pulmonary function testing
|
it will be measured after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced expiratory volume
Time Frame: It will be measured after 12 weeks
|
it is a pulmonary function testing at the first second of expiration
|
It will be measured after 12 weeks
|
|
forced expiratory volume to forced expiratory capcity
Time Frame: It will be measured after 12 weeks
|
it is a common ratio test in pulmonary function examiantions
|
It will be measured after 12 weeks
|
|
body mass index
Time Frame: It will be measured after 12 weeks
|
it will be assessed on empty stomach and bladder
|
It will be measured after 12 weeks
|
|
waist circumference
Time Frame: it will be measured after 12 weeks
|
it will be assessed at level of patient umblicus
|
it will be measured after 12 weeks
|
|
waist hip ratio
Time Frame: It will be measured after 12 weeks
|
it is a measure of excess weight
|
It will be measured after 12 weeks
|
|
Mini asthma quality of life questionnaire
Time Frame: It will be measured after 12 weeks
|
it is a questioanire assessing life quality in asthma
|
It will be measured after 12 weeks
|
|
scale of fatigue severity
Time Frame: It will be measured after 12 weeks
|
it is a questionaire assesing fatigue
|
It will be measured after 12 weeks
|
|
luteinizing-hormone to follicle-stimulating-hormone ratio
Time Frame: It will be measured after 12 weeks
|
it is an indicator on level of sex hormone production
|
It will be measured after 12 weeks
|
|
Testosterone
Time Frame: It will be measured after 12 weeks
|
it is androgen hormone
|
It will be measured after 12 weeks
|
|
Dehydroepiandrosterone
Time Frame: It will be measured after 12 weeks
|
it is a hormone that body naturally produces in the adrenal gland
|
It will be measured after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, lecturer, Cairo University
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 (Actual)
February 7, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 15, 2026
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 26, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Immune System Diseases
- Respiratory Tract Diseases
- Genital Diseases, Female
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Cysts
- Cysts
- Asthma
- Polycystic Ovary Syndrome
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- IRB000-14233-69
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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