Poly Cystic Ovary SyndromeNCT07871175
Inspiratory Muscle Training for the Management of Polyendocrine Metabolic Ovarian Syndrome
A study testing Exercise in people with Poly Cystic Ovary Syndrome, run by British University In Egypt at 1 site in Egypt.
Trial summary
Inspiratory muscle training (IMT) is a relatively simple and accessible form of exercise that specifically targets the respiratory muscles and has been reported to improve inspiratory muscle strength, respiratory efficiency, exercise capacity, and autonomic cardiovascular regulation in different populations. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poly Cystic Ovary Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2026to 10 Dec 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Polycystic ovarian syndrome
Who cannot join
- pelvic tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Training for the Management of Polyendocrine Metabolic Ovarian Syndrome: A Randomized Controlled Trial
Inspiratory muscle training (IMT) is a relatively simple and accessible form of exercise that specifically targets the respiratory muscles and has been reported to improve inspiratory muscle strength, respiratory efficiency, exercise capacity, and autonomic cardiovascular regulation in different populations. Given the close relationship between respiratory muscle function, exercise capacity, autonomic regulation, and metabolic health, IMT may represent a potentially useful adjunctive intervention for women with PCOS. Therefore, investigating the effects of inspiratory muscle training on relevant metabolic, functional, and clinical outcomes in women with PCOS may provide an additional therapeutic approach within physiotherapy and lifestyle-based management.
- Conditions
- Poly Cystic Ovary Syndrome
- Being tested
- Exercise
- Keywords
- polycystic ovary syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Training consisted of two sets of 30 inspiratory efforts per day, performed 5 days per week for 8 weeks. MIP was reassessed weekly, and the training resistance was adjusted to maintain an intensity corresponding to 50% of the current MIP. Participants performed the training in a standardized seated position following standardized breathing instructions.
| Study group | Role | What they receive |
|---|---|---|
| inspiratory muscle training | Experimental | Participants performed inspiratory muscle training using a The POWER breathe equipment (POWER breathe International Ltd.) at 50% of maximal inspiratory pressure (MIP). Training consisted of two sets of 30 inspiratory efforts per day, performed 5 days per week for 8 weeks. MIP was reassessed weekly, and the training resistance was adjusted to maintain an intensity corresponding to 50% of the current MIP. Participants performed the training in a standardized seated position following standardized breathing instructions. Receives: Other: Exercise |
| Sham IMT control group | Sham comparator | Participants allocated to the sham group used the same threshold inspiratory loading device with the inspiratory resistance set at 10% of MIP. They performed the same training schedule as the intervention group (two sets of 30 inspiratory efforts per day, 5 days per week for 8 weeks) and received identical instructions and follow-up procedures. The sham resistance was maintained at a minimal level insufficient to induce a meaningful inspiratory muscle-training stimulus. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic model assessment of IR (HOMA- IR),
Measured: 8 weeks
Secondary outcomes (4)
Hormonal profile (FSH, LH, FSH-LH ratio)
Measured: 8 weeks
Serum triglyceride (TG)
Measured: 8 weeks
HDL
Measured: 8 weeks
LDL
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Oct 2026
- Primary completion2 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miral saleh, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871175
- Sponsor's protocol ID
- IMTPCO
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reed BL, Tavoian D, Bailey EF, Funk JL, Coletta DK. Inspiratory muscle strength training to improve cardiometabolic health in patients with type 2 diabetes mellitus: protocol for the diabetes inspiratory training clinical trial. Front Endocrinol (Lausanne). 2024 Sep 13;15:1383131. doi: 10.3389/fendo.2024.1383131. eCollection 2024.
PubMed 39345888
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training for the Management of Polyendocrine Metabolic Ovarian Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07871175
- Acronym / sponsor ID
- IMTPCO
- Conditions
- Poly Cystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 13 Oct 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.
Inspiratory muscle training (IMT) is a relatively simple and accessible form of exercise that specifically targets the respiratory muscles and has been reported to improve inspiratory muscle strength, respiratory efficiency, exercise capacity, and autonomic cardiovascular regulation in different populations. Given the close relationship between respiratory muscle function, exercise capacity, autonomic regulation, and metabolic health, IMT may represent a potentially useful adjunctive intervention for women with PCOS. Therefore, investigating the effects of inspiratory muscle training on relevant metabolic, functional, and clinical outcomes in women with PCOS may provide an additional therapeutic approach within physiotherapy and lifestyle-based management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inspiratory muscle training | Experimental | Other: ExerciseParticipants performed inspiratory muscle training using a The POWER breathe equipment (POWER breathe International Ltd.) at 50% of maximal inspiratory pressure (MIP). Training consisted of two sets of 30 inspiratory efforts per day, performed 5 days per week for 8 weeks. MIP was reassessed weekly, and the training resistance was adjusted to maintain an intensity corresponding to 50% of the current MIP. Participants performed the training in a standardized seated position following standardized breathing instructions. |
| Sham IMT control group | Sham comparator | Other: ExerciseParticipants allocated to the sham group used the same threshold inspiratory loading device with the inspiratory resistance set at 10% of MIP. They performed the same training schedule as the intervention group (two sets of 30 inspiratory efforts per day, 5 days per week for 8 weeks) and received identical instructions and follow-up procedures. The sham resistance was maintained at a minimal level insufficient to induce a meaningful inspiratory muscle-training stimulus. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polycystic ovarian syndrome
Key exclusion criteria (1 listed)
- pelvic tumors
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 |
|---|---|---|
| ExerciseTraining consisted of two sets of 30 inspiratory efforts per day, performed 5 days per week for 8 weeks. MIP was reassessed weekly, and the training resistance was adjusted to maintain an intensity corresponding to 50% of the current MIP. Participants performed the training in a standardized seated position following standardized breathing instructions. | Other | Sham IMT control group, inspiratory muscle training |
Primary outcome
Homeostatic model assessment of IR (HOMA- IR),
Time frame: 8 weeks
4 secondary outcomes
Hormonal profile (FSH, LH, FSH-LH ratio)
Time frame: 8 weeks
Serum triglyceride (TG)
Time frame: 8 weeks
HDL
Time frame: 8 weeks
LDL
Time frame: 8 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 13 Oct 2026.
- Background: PubMed 39345888Reed BL, Tavoian D, Bailey EF, Funk JL, Coletta DK. Inspiratory muscle strength training to improve cardiometabolic health in patients with type 2 diabetes mellitus: protocol for the diabetes inspiratory training clinical trial. Front Endocrinol (Lausanne). 2024 Sep 13;15:1383131. doi: 10.3389/fendo.2024.1383131. eCollection 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Poly Cystic Ovary Syndrome, run by British University In Egypt 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 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. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic model assessment of IR (HOMA- IR), (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07871175, which also lists 1 linked publication.
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 13 Oct 2026.