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PCOS & Insulin Resistance Exercise Study

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ClinicalTrials.gov Identifier: NCT02303470
Recruitment Status : Active, not recruiting
First Posted : December 1, 2014
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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
Polycystic Ovary Syndrome Insulin Resistance Behavioral: Vigorous Exercise Behavioral: Moderate Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2015
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: High-intensity interval training

Experimental: Moderate Exercise
Brisk walking for 30 minutes daily, 5 days per week for 8 weeks
Behavioral: Moderate Exercise



Primary Outcome Measures :
  1. Drop-out Rate [ Time Frame: 8 weeks ]
    Drop-out rate in each arm as a measure of feasibility

  2. Completed Days of Exercise [ Time Frame: 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) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
    Change in HOMA-IR (calculated from fasting glucose and insulin levels)

  2. Fasting Insulin [ Time Frame: Baseline, 4 weeks, 8 weeks ]
    Change in fasting insulin level

  3. Total Cholesterol [ Time Frame: Baseline, 8 weeks ]
    Change in total cholesterol level

  4. LDL Cholesterol [ Time Frame: Baseline, 8 weeks ]
    Change in LDL cholesterol level

  5. HDL Cholesterol [ Time Frame: Baseline, 8 weeks ]
    Change in HDL cholesterol level

  6. Triglycerides [ Time Frame: Baseline, 8 weeks ]
    Change in triglyceride level

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

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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303470


Locations
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United States, California
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Heather Huddleston, MD University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02303470    
Other Study ID Numbers: 14-14816
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Keywords provided by University of California, San Francisco:
Exercise
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases