PCOS & Insulin Resistance Exercise Study

NCT02303470 | Active Not Recruiting DMC

• 1 other identifier: 14-14816
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Polycystic Ovary Syndrome; Insulin Resistance

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• Drop-out Rate

  Drop-out rate in each arm as a measure of feasibility

  8 weeks

• Completed Days of Exercise

  Percentage of completed days of exercise program in each arm as a measure of feasibility

  8 weeks

Secondary Outcomes (8)

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline, 4 weeks, 8 weeks

• Fasting Insulin

  Baseline, 4 weeks, 8 weeks

• Total Cholesterol

  Baseline, 8 weeks

• LDL Cholesterol

  Baseline, 8 weeks

• HDL Cholesterol

  Baseline, 8 weeks

Study Arms (2)

Vigorous Exercise

EXPERIMENTAL

High-intensity interval training for 15 minutes daily, 5 days per week for 8 weeks

Behavioral: Vigorous Exercise

Moderate Exercise

EXPERIMENTAL

Brisk walking for 30 minutes daily, 5 days per week for 8 weeks

Behavioral: Moderate Exercise

Interventions

Vigorous Exercise BEHAVIORAL

High-intensity interval training alternates 30 seconds of vigorous exercise with 30 seconds of low-intensity recovery for a total of 15 minutes.

Also known as: High-intensity interval training

Vigorous Exercise

Moderate Exercise BEHAVIORAL

Moderate Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94158, United States

Location

Related Publications (14)

• Teede 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 BACKGROUND

• Hoeger 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 BACKGROUND

• Moran 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 BACKGROUND

• Palomba 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 BACKGROUND

• Vigorito 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 BACKGROUND

• Laursen 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.

  PMID: 11772161 BACKGROUND

• Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004 Jun;11(3):216-22. doi: 10.1097/01.hjr.0000131677.96762.0c.

  PMID: 15179103 BACKGROUND

• Racil G, Ben Ounis O, Hammouda O, Kallel A, Zouhal H, Chamari K, Amri M. Effects of high vs. moderate exercise intensity during interval training on lipids and adiponectin levels in obese young females. Eur J Appl Physiol. 2013 Oct;113(10):2531-40. doi: 10.1007/s00421-013-2689-5. Epub 2013 Jul 4.

  PMID: 23824463 BACKGROUND

• Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slordahl SA, Kemi OJ, Najjar SM, Wisloff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008 Jul 22;118(4):346-54. doi: 10.1161/CIRCULATIONAHA.108.772822. Epub 2008 Jul 7.

  PMID: 18606913 BACKGROUND

• Balducci S, Zanuso S, Cardelli P, Salvi L, Bazuro A, Pugliese L, Maccora C, Iacobini C, Conti FG, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of high- versus low-intensity supervised aerobic and resistance training on modifiable cardiovascular risk factors in type 2 diabetes; the Italian Diabetes and Exercise Study (IDES). PLoS One. 2012;7(11):e49297. doi: 10.1371/journal.pone.0049297. Epub 2012 Nov 21.

  PMID: 23185314 BACKGROUND

• Shaban N, Kenno KA, Milne KJ. The effects of a 2 week modified high intensity interval training program on the homeostatic model of insulin resistance (HOMA-IR) in adults with type 2 diabetes. J Sports Med Phys Fitness. 2014 Apr;54(2):203-9.

  PMID: 24509992 BACKGROUND

• Hoeger KM, Kochman L, Wixom N, Craig K, Miller RK, Guzick DS. A randomized, 48-week, placebo-controlled trial of intensive lifestyle modification and/or metformin therapy in overweight women with polycystic ovary syndrome: a pilot study. Fertil Steril. 2004 Aug;82(2):421-9. doi: 10.1016/j.fertnstert.2004.02.104.

  PMID: 15302293 BACKGROUND

• Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.

  PMID: 11153730 BACKGROUND

• Wang A, Noel M, Christ JP, Corley J, Lenhart N, Cedars MI, Huddleston H. Vigorous vs. moderate exercise to improve glucose metabolism in inactive women with polycystic ovary syndrome and insulin resistance: a pilot randomized controlled trial of two home-based exercise routines. F S Rep. 2023 Dec 22;5(1):80-86. doi: 10.1016/j.xfre.2023.12.004. eCollection 2024 Mar.

  PMID: 38524210 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

US (1)