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PCOS & Insulin Resistance Exercise Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02303470
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
81.1
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vigorous Exercise
  • Behavioral: Moderate Exercise
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vigorous Exercise

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

Behavioral: Vigorous Exercise
High-intensity interval training alternates 30 seconds of vigorous exercise with 30 seconds of low-intensity recovery for a total of 15 minutes.
Other Names:
  • High-intensity interval training

    		•
    Experimental: Moderate Exercise

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

    Behavioral: Moderate Exercise

    Outcome Measures

    Primary Outcome Measures

    1. Drop-out Rate [8 weeks]

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

    2. Completed Days of Exercise [8 weeks]

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

    Secondary Outcome Measures

    1. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Baseline, 4 weeks, 8 weeks]

      Change in HOMA-IR (calculated from fasting glucose and insulin levels)

    2. Fasting Insulin [Baseline, 4 weeks, 8 weeks]

      Change in fasting insulin level

    3. Total Cholesterol [Baseline, 8 weeks]

      Change in total cholesterol level

    4. LDL Cholesterol [Baseline, 8 weeks]

      Change in LDL cholesterol level

    5. HDL Cholesterol [Baseline, 8 weeks]

      Change in HDL cholesterol level

    6. Triglycerides [Baseline, 8 weeks]

      Change in triglyceride level

    7. Psychological Effects (Change in performance on Beck Depression Inventory - Fast Screen) [Baseline, 8 weeks]

      Change in performance on Beck Depression Inventory - Fast Screen

    8. Androgens (Change in free/total testosterone) [Baseline, 8 weeks]

      Change in free/total testosterone

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Center for Reproductive Health San Francisco California United States 94158

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Heather Huddleston, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT02303470
    Other Study ID Numbers:
    • 14-14816
    First Posted:
    Dec 1, 2014
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by University of California, San Francisco
    Exercise
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Insulin Resistance
    Syndrome

    Study Results

    No Results Posted as of Jul 21, 2021