Polycystic Ovary SyndromeNCT04744948
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
A study testing Treadmill exercise and low caloric diet in people with Polycystic Ovary Syndrome and Irregular Menses, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women Read more about this study
- Who is it for?
- Ages 17 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Irregular Menses
- What is being tested?
- Treadmill exercise and low caloric diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 28 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women with pco
- age from17 to 28 years
- BMI 25- 30
Who cannot join
- Asthma and chronic respiratory disease
- congenital spinal problems
- cardiopulmonary disease
- physical impairments
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 14788
miral s mohamed, md, 01200678845 ext. +012, marmooramido@gmail.com
About this study
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women
Read the detailed description
This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise
- Conditions
- Polycystic Ovary Syndrome, Irregular Menses
- Being tested
- Treadmill exercise, low caloric diet
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill exerciseDevice
high intensity interval training
low caloric dietOther
low caloric diet (1200ca/lday)
| Study group | Role | What they receive |
|---|---|---|
| low caloric diet | Placebo comparator | low caloric diet 1200cal/day Receives: Other: low caloric diet |
| treadmill | Experimental | treadmill aerobic exercise training Receives: Device: Treadmill exercise; Other: low caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual regularity
Oligomenorrhea (menses every 6 weeks to 6 months), amenorrhea (menses greater than every 6 months apart or their absence), regular ( menses every 28-35 days)
Measured: 3 months
quality of life questionnaire (QOLQ)
a total of 26 items for the Polycystic Ovary Syndrome Questionnaire, each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (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
- Model description
- control group receive low caloric diet study group receive high intensity interval training
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miral Saleh Mohamed, Cairo University
- Investigators
- fahema m okiel, phd, Study director, Cairo Universityamal mo youssef, phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744948
- Sponsor's protocol ID
- ETMQWP
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT04744948
- Acronym / sponsor ID
- ETMQWP
- Conditions
- Polycystic Ovary Syndrome, Irregular Menses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 9 Feb 2021 (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.
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women
Detailed description
This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group receive low caloric diet study group receive high intensity interval training
| Arm | Type | Receives |
|---|---|---|
| low caloric diet | Placebo comparator | Other: low caloric dietlow caloric diet 1200cal/day |
| treadmill | Experimental | Device: Treadmill exercise, Other: low caloric diettreadmill aerobic exercise training |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- women with pco
- age from17 to 28 years
- BMI 25- 30
Key exclusion criteria (4 listed)
- Asthma and chronic respiratory disease
- congenital spinal problems
- cardiopulmonary disease
- physical impairments
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 |
|---|---|---|
| Treadmill exercisehigh intensity interval training | Device | treadmill |
| low caloric dietlow caloric diet (1200ca/lday) | Other | low caloric diet, treadmill |
Primary outcome
menstrual regularity
Time frame: 3 months
Oligomenorrhea (menses every 6 weeks to 6 months), amenorrhea (menses greater than every 6 months apart or their absence), regular ( menses every 28-35 days)
quality of life questionnaire (QOLQ)
Time frame: 3 months
a total of 26 items for the Polycystic Ovary Syndrome Questionnaire, each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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. This study is not recruiting at the moment.
fahema m okiel, phd study director
Cairo University
amal mo youssef, phd study chair
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 Treadmill exercise and low caloric diet in people with Polycystic Ovary Syndrome and Irregular Menses, 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 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact miral m saleh, md (01200678845 ext. +012, marmooramido@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstrual regularity (time frame: 3 months). The study lists 2 primary outcomes in all. 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 23 Feb 2021.