Clinical trial · Interventional
PCOS & Insulin Resistance Exercise Study
Vigorous Exercise Versus Moderate Exercise to Improve Glucose Metabolism and Metabolic Parameters in Women With Polycystic Ovary Syndrome and Insulin Resistance: A Prospective Randomized Pilot Study
NCT02303470CI-TRIAL-00078079unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the feasibility and metabolic effects of implementing a structured exercise program in women with polycystic ovary syndrome and insulin resistance. Participants will be randomized to either 75 minutes of vigorous exercise or 150 minutes of moderate exercise per week.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate Exercise | Behavioral | — | UNRESOLVED |
| Vigorous Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vigorous Exercise
- description
- High-intensity interval training for 15 minutes daily, 5 days per week for 8 weeks
- interventionNames
- Behavioral: Vigorous Exercise
- type
- EXPERIMENTAL
- label
- Moderate Exercise
- description
- Brisk walking for 30 minutes daily, 5 days per week for 8 weeks
- interventionNames
- Behavioral: Moderate Exercise
Primary outcomes (2)
- measure
- Drop-out Rate
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of PCOS as defined by the 2003 Rotterdam criteria * Presence of insulin resistance as defined by HOMA IR (Insulin Resistance) \> 2.0 or fasting insulin ≥ 12 milliunits per liter (mU/L) * Physician judges that patient is in adequate physical condition to complete exercise program Exclusion Criteria: * Age \<18 years old or \>50 years old * BMI \>40 kg/m2 * Current tobacco user * Presence of the following pre-existing co-morbid conditions: diabetes mellitus type 2, uncontrolled hypertension (\>140/90mmHg), cardiovascular disease * Presence of musculoskeletal injury or disease that would interfere with patient's ability to complete exercise program * Current pregnancy or planning to attempt to conceive in the next 3 months
References
Publications (14)
- BACKGROUNDTeede HJ, Hutchison SK, Zoungas S. The management of insulin resistance in polycystic ovary syndrome. Trends Endocrinol Metab. 2007 Sep;18(7):273-9. doi: 10.1016/j.tem.2007.08.001. Epub 2007 Aug 16. PMID 17698366
- BACKGROUNDHoeger K, Davidson K, Kochman L, Cherry T, Kopin L, Guzick DS. The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials. J Clin Endocrinol Metab. 2008 Nov;93(11):4299-306. doi: 10.1210/jc.2008-0461. Epub 2008 Aug 26. PMID 18728175
- BACKGROUNDMoran LJ, Pasquali R, Teede HJ, Hoeger KM, Norman RJ. Treatment of obesity in polycystic ovary syndrome: a position statement of the Androgen Excess and Polycystic Ovary Syndrome Society. Fertil Steril. 2009 Dec;92(6):1966-82. doi: 10.1016/j.fertnstert.2008.09.018. Epub 2008 Dec 4. PMID 19062007
- BACKGROUNDPalomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23. PMID 18158291
- BACKGROUNDVigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Apr;92(4):1379-84. doi: 10.1210/jc.2006-2794. Epub 2007 Jan 30. PMID 17264174
- BACKGROUNDLaursen PB, Jenkins DG. The scientific basis for high-intensity interval training: optimising training programmes and maximising performance in highly trained endurance athletes. Sports Med. 2002;32(1):53-73. doi: 10.2165/00007256-200232010-00003.