Polycystic Ovary SyndromeNCT07446985
Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma?
A study testing exercise plus limiitng diet and limiting diet in people with Polycystic Ovary Syndrome and Asthma, run by Cairo University at 1 site in Egypt.
Trial summary
Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Asthma
- What is being tested?
- exercise plus limiitng diet and limiting diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS women
- women with asthma
- obese women (calss I)
Who cannot join
- cardiac problems
- renal problems
- liver problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems
Read the 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
- Conditions
- Polycystic Ovary Syndrome, Asthma
- Being tested
- exercise plus limiitng diet, limiting diet
- Medical subject headings
- Polycystic Ovary Syndrome, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise plus limiitng dietBehavioural
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.
limiting dietBehavioural
Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | 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. Receives: Behavioral: exercise plus limiitng diet |
| group number 2 | Active comparator | Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks Receives: Behavioral: limiting diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capcity
it is a pulmonary function testing
Measured: it will be measured after 12 weeks
Secondary outcomes (10)
forced expiratory volume
it is a pulmonary function testing at the first second of expiration
Measured: It will be measured after 12 weeks
forced expiratory volume to forced expiratory capcity
it is a common ratio test in pulmonary function examiantions
Measured: It will be measured after 12 weeks
body mass index
it will be assessed on empty stomach and bladder
Measured: It will be measured after 12 weeks
waist circumference
it will be assessed at level of patient umblicus
Measured: it will be measured after 12 weeks
waist hip ratio
it is a measure of excess weight
Measured: It will be measured after 12 weeks
Mini asthma quality of life questionnaire
it is a questioanire assessing life quality in asthma
Measured: It will be measured after 12 weeks
scale of fatigue severity
it is a questionaire assesing fatigue
Measured: It will be measured after 12 weeks
luteinizing-hormone to follicle-stimulating-hormone ratio
it is an indicator on level of sex hormone production
Measured: It will be measured after 12 weeks
Testosterone
it is androgen hormone
Measured: It will be measured after 12 weeks
Dehydroepiandrosterone
it is a hormone that body naturally produces in the adrenal gland
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446985
- Sponsor's protocol ID
- IRB000-14233-69
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma?
- ClinicalTrials.gov ID
- NCT07446985
- Acronym / sponsor ID
- IRB000-14233-69
- Conditions
- Polycystic Ovary Syndrome, Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: exercise plus limiitng dietGroup 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 number 2 | Active comparator | Behavioral: limiting dietGroup II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOS women
- women with asthma
- obese women (calss I)
Key exclusion criteria (3 listed)
- cardiac problems
- renal problems
- liver problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise plus limiitng dietGroup 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. | Behavioural | group number 1 |
| limiting dietGroup II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks | Behavioural | group number 2 |
Primary outcome
forced vital capcity
Time frame: it will be measured after 12 weeks
it is a pulmonary function testing
10 secondary outcomes
forced expiratory volume
Time frame: It will be measured after 12 weeks
forced expiratory volume to forced expiratory capcity
Time frame: It will be measured after 12 weeks
body mass index
Time frame: It will be measured after 12 weeks
waist circumference
Time frame: it will be measured after 12 weeks
waist hip ratio
Time frame: It will be measured after 12 weeks
Mini asthma quality of life questionnaire
Time frame: It will be measured after 12 weeks
scale of fatigue severity
Time frame: It will be measured after 12 weeks
luteinizing-hormone to follicle-stimulating-hormone ratio
Time frame: It will be measured after 12 weeks
Testosterone
Time frame: It will be measured after 12 weeks
Dehydroepiandrosterone
Time frame: It will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise plus limiitng diet and limiting diet in people with Polycystic Ovary Syndrome and Asthma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capcity (time frame: it will be measured after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.