PCOS & Insulin Resistance Exercise Study

June 17, 2024 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Center for Reproductive Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drop-out Rate
Time Frame: 8 weeks
Drop-out rate in each arm as a measure of feasibility
8 weeks
Completed Days of Exercise
Time Frame: 8 weeks
Percentage of completed days of exercise program in each arm as a measure of feasibility
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 4 weeks, 8 weeks
Fasting Insulin
Time Frame: Baseline, 4 weeks, 8 weeks
Change in fasting insulin level
Baseline, 4 weeks, 8 weeks
Total Cholesterol
Time Frame: Baseline, 8 weeks
Change in total cholesterol level
Baseline, 8 weeks
LDL Cholesterol
Time Frame: Baseline, 8 weeks
Change in LDL cholesterol level
Baseline, 8 weeks
HDL Cholesterol
Time Frame: Baseline, 8 weeks
Change in HDL cholesterol level
Baseline, 8 weeks
Triglycerides
Time Frame: Baseline, 8 weeks
Change in triglyceride level
Baseline, 8 weeks
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
Baseline, 8 weeks
Androgens (Change in free/total testosterone)
Time Frame: Baseline, 8 weeks
Change in free/total testosterone
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimated)

December 1, 2014

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-14816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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