MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation

Exclusion Criteria

• •Use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD) during the 2 months before enrollment. Vaginal postmenopausal estrogens allowed, with the exception of vaginal creams used more than 3 times a week.
• •Use of any other therapy that is taken specifically for hot flashes, including prescription, over-the-counter, or herbal therapies, in the past month.
• •Any current severe or unstable medical illness.
• •Body mass index (BMI) of 37 or higher, based on measured height and weight.
• •Severe uncorrected hearing or vision problems.
• •Current, regular use of anti-coagulants 3 or more times per week, e.g. Coumadin, Heparin, Clopidogrel, aspirin at full dose (due to possible omega-3 supplement interaction).
• •Drug or alcohol abuse in the past 1 year.
• •Major severe depressive episode in the past 3 months.
• •Diagnosis of psychosis or psychotic disorder.
• •Pregnancy, intending pregnancy, or breastfeeding.
• •Current participation in another drug trial or intervention study.
• •Inability or unwillingness to complete the study procedures or interventions.
• •Physical limitations that limit the ability to participate in yoga or exercise, for example:
• •* Limited mobility (paralyzed, cannot walk 2 blocks);
• •* Back problems (severe spine abnormality, sciatica, prior back surgery, spine fracture in the past 3 months);
• •* musculoskeletal problems that limit the ability to walk on a treadmill or ride a stationary bicycle;
• •Presence of any absolute contraindications to exercise testing and training, as defined by the American College of Sports Medicine.
• •Practiced or attended any of the following in the prior 3 months:
• •* Yoga, tai chi, qi gong, or meditation more than one time per week on average;
• •* Aerobic exercise (more than 30 minutes a day on at least 3 days a week);
• •* Inability to achieve 85% of heart rate reserve (HRR; the difference between maximum heart rate and resting heart rate) on graded exercise treadmill test.
• •Severe allergy to soy (defined as life-threatening reaction to soy that would require medical intervention).
• •Allergy or sensitivity to fish.
• •Currently eating 4 or more servings of fish per week.
• •Currently taking an omega-3 fish oil supplement more than twice per week in the past 4 weeks and unwilling to stop for 12 weeks. Interest women can stop all omega-3 supplements and reevaluate eligibility 4 weeks after stopping the omega-3 supplements.