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PCOS & Insulin Resistance Exercise Study

Primary Purpose

Polycystic Ovary Syndrome, Insulin Resistance

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vigorous Exercise
Moderate Exercise
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Center for Reproductive Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vigorous Exercise

Moderate Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Drop-out Rate
Drop-out rate in each arm as a measure of feasibility
Completed Days of Exercise
Percentage of completed days of exercise program in each arm as a measure of feasibility

Secondary Outcome Measures

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in HOMA-IR (calculated from fasting glucose and insulin levels)
Fasting Insulin
Change in fasting insulin level
Total Cholesterol
Change in total cholesterol level
LDL Cholesterol
Change in LDL cholesterol level
HDL Cholesterol
Change in HDL cholesterol level
Triglycerides
Change in triglyceride level
Psychological Effects (Change in performance on Beck Depression Inventory - Fast Screen)
Change in performance on Beck Depression Inventory - Fast Screen
Androgens (Change in free/total testosterone)
Change in free/total testosterone

Full Information

First Posted
November 25, 2014
Last Updated
December 1, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02303470
Brief Title
PCOS & Insulin Resistance Exercise Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder with an incidence of 5-8% in reproductive aged women. PCOS is characterized by a collection of signs and symptoms, and as defined by the 2003 Rotterdam criteria must include two out of the following three characteristics: oligo-ovulation or anovulation, polycystic-appearing ovaries, and clinical or biochemical evidence of elevated androgens. Women with PCOS are also known to have an increased risk of metabolic disorders, including insulin resistance, obesity, cardiovascular disease, and hyperlipidemia. It is has been shown that many of the sequelae of PCOS can be improved by interventions that reduce insulin levels. Previous research has demonstrated that weight reduction and metformin are beneficial in restoring normal ovulation patterns and fertility and can improve hyperandrogenemia and hyperlipidemia. Studies of the effect of lifestyle modifications in women with PCOS have shown that exercise, alone or in combination with changes in diet, can improve ovulation rates and metabolic parameters, and is associated with reduced incidence of insulin resistance. As such, the care of PCOS patients often includes counseling regarding reducing dietary intake and improvement in physical fitness. However, the type of exercise evaluated was inconsistent between many of these studies and varied in intensity, frequency and duration. Therefore, the exercise needed to achieve health benefits in PCOS is not well defined. The Department of Health and Human Services (DHHS) recommends that all Americans get at least 150 minutes per week of moderate aerobic exercise or at least 75 minutes per week of vigorous aerobic activity to maintain health and fitness for all Americans. A critical unanswered question is whether one of these options (moderate versus vigorous) provides superior benefits to women with PCOS. High-intensity interval training (HIIT) is a form of exercise that combines short intervals of vigorous exercise with lower intensity recovery periods. HIIT has been used as a training modality for high-performance athletes for over a decade. More recently, it has been studied for therapeutic purposes in adults with cardiovascular disease, obesity, and metabolic syndrome. These data suggest that when compared to moderate exercise, HIIT shows greater improvement in aerobic capacity, maximal oxygen consumption, indices of insulin resistance, hyperglycemia, and lipid profiles. HIIT has also been compared with moderate-intensity exercise in patients with type 2 diabetes and has shown a reduction in hyperglycemia, though the data have been controversial. HIIT has not been studied specifically in patients with PCOS. Studies employing structured exercise programs often have a high drop-out rate and poor post-study continuation rate. An exercise program that requires a fitness facility or other equipment may create a barrier to patient compliance. Additionally, time constraints are often cited as a reason for patient drop-out. Our goal is to create an effective exercise program that can be completed in or around the home, requiring only 15-30 minutes per day. Participants will be randomized to either 15 minutes of vigorous exercise (HIIT) or 30 minutes of moderate exercise (brisk walking) to be performed 5 days per week for 8 weeks. Exercise training will be performed by an exercise physiologist and participants will then complete their exercise programs independently, using heart rate monitoring and exercise diaries to record exercise intensity. This study will evaluate the feasibility of these exercise plans in terms of patient compliance and safety. We will also evaluate the effect of short-duration, vigorous exercise versus longer-duration, moderate exercise on secondary outcomes such as insulin resistance and metabolic parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
Keywords
Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vigorous Exercise
Arm Type
Experimental
Arm Description
High-intensity interval training for 15 minutes daily, 5 days per week for 8 weeks
Arm Title
Moderate Exercise
Arm Type
Experimental
Arm Description
Brisk walking for 30 minutes daily, 5 days per week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Vigorous Exercise
Other Intervention Name(s)
High-intensity interval training
Intervention Description
High-intensity interval training alternates 30 seconds of vigorous exercise with 30 seconds of low-intensity recovery for a total of 15 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Moderate Exercise
Primary Outcome Measure Information:
Title
Drop-out Rate
Description
Drop-out rate in each arm as a measure of feasibility
Time Frame
8 weeks
Title
Completed Days of Exercise
Description
Percentage of completed days of exercise program in each arm as a measure of feasibility
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Description
Change in HOMA-IR (calculated from fasting glucose and insulin levels)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Fasting Insulin
Description
Change in fasting insulin level
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Total Cholesterol
Description
Change in total cholesterol level
Time Frame
Baseline, 8 weeks
Title
LDL Cholesterol
Description
Change in LDL cholesterol level
Time Frame
Baseline, 8 weeks
Title
HDL Cholesterol
Description
Change in HDL cholesterol level
Time Frame
Baseline, 8 weeks
Title
Triglycerides
Description
Change in triglyceride level
Time Frame
Baseline, 8 weeks
Title
Psychological Effects (Change in performance on Beck Depression Inventory - Fast Screen)
Description
Change in performance on Beck Depression Inventory - Fast Screen
Time Frame
Baseline, 8 weeks
Title
Androgens (Change in free/total testosterone)
Description
Change in free/total testosterone
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Huddleston, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Center for Reproductive Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17698366
Citation
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.
Results Reference
background
PubMed Identifier
18728175
Citation
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.
Results Reference
background
PubMed Identifier
19062007
Citation
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.
Results Reference
background
PubMed Identifier
18158291
Citation
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.
Results Reference
background
PubMed Identifier
17264174
Citation
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.
Results Reference
background
PubMed Identifier
11772161
Citation
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.
Results Reference
background
PubMed Identifier
15179103
Citation
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.
Results Reference
background
PubMed Identifier
23824463
Citation
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.
Results Reference
background
PubMed Identifier
18606913
Citation
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.
Results Reference
background
PubMed Identifier
23185314
Citation
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.
Results Reference
background
PubMed Identifier
24509992
Citation
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.
Results Reference
background
PubMed Identifier
15302293
Citation
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.
Results Reference
background
PubMed Identifier
11153730
Citation
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.
Results Reference
background

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PCOS & Insulin Resistance Exercise Study

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