MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
Condition: Hot Flashes; Menopause; Vasomotor Symptoms
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      This study is the second clinical trial to be conducted by the Menopause Strategies - Finding
      Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of investigators
      conducting clinical trials designed to find new ways to alleviate the most common, bothersome
      symptoms of the menopausal transition.

      In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal
      transition or postmenopausal and experiencing bothersome hot flashes will be randomized to
      one of three behavioral intervention groups: yoga, exercise, or usual activity. All women
      will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.

      The primary aims of this trial are to compare the magnitude of changes in perceived,
      self-reported frequency and bother of vasomotor symptoms (VMS) before and after the
      intervention between yoga and the usual activity comparison group, between exercise and the
      usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.
      The hypotheses to be tested are:

        1. Women assigned to yoga will report lower frequency and less VMS bother than women
           assigned to the usual activity group at the end of a 12-week study period.

        2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower
           frequency and less VMS bother than women assigned to the usual activity group at the end
           of a 12-week study period.

        3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and
           less VMS bother than women assigned to the placebo group at the end of a 12-week study
           period.

      The omega-3 component of the study is double-blinded. For yoga, exercise, and usual activity,
      the outcomes assessors are blinded to the randomization assignments.
    

Detailed description: 
      Over 33 million U.S. women will transition through menopause in the next decade. Among women
      with natural menopause, the transition typically lasts four years, with a mean age at
      menopause of 51 years. Menstrual irregularity (90%) and vasomotor symptoms (VMS) (80%) are
      the most common symptoms associated with the transition. Hormone therapy has been the gold
      standard for treating VMS symptoms against which other therapies are measured. However,
      resistance to hormone therapy use due to its risks and side effects continues to fuel the
      search for safer alternatives.

      This research study will evaluate three low risk interventions (yoga, exercise, and omega-3
      supplements) compared to either a usual activity group or a placebo pill. This factorial
      design is motivated by the desire to have all women receive some intervention. Neither
      comparisons between yoga and exercise nor tests of interaction between the behavioral
      interventions (yoga, exercise, usual activity) and omega-3 motivated this design. However,
      these aspects can be examined in secondary analyses in a more rigorous fashion through this
      design than would be permitted by separate trials.
    

Intervention name(s): Placebo; Omega-3; Yoga; Exercise; Usual Activity
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral; Behavioral; Behavioral
Intervention description(s): Three placebo gel capsules filled with vegetable oil are taken daily for a total of approximately 2 grams of vegetable oil. Each gel capsule also contains 15 IU of vitamin E, natural lemon flavoring, rosemary extract, and a small amount of non-omega-3 fish oil.; The study supplement, omega-3-fish oils, is taken as 3 gel capsules daily that together contain approximately 2 grams of fish oil. Each gel capsule (1/3 of the daily dose) has a total omega-3 dosage of 615 mg with two major omega-3 components of ethyl eicosapentaenoic acid (EPA; 425 mg) and docosahexaenoic acid (DHA; 100 mg). Vitamin E (15 IU), an antioxidant, is added to each gel capsule to prevent oxidation and preserve freshness. Each gel capsule also contains natural lemon oil and rosemary extract to enhance taste and freshness.; Yoga instruction is provided during 12 weekly 90-minute classes, designed for women without prior yoga experience. Each class includes an introductory breathing exercise, 11 to 13 gentle postures followed by deep relaxation with a visualization exercise. Study participants are expected to attend each of the 12 weekly yoga classes plus do daily 20-minute at-home practices. Classes are offered at 2 different times during the week.; The exercise intervention is facility-based aerobic exercise training on a treadmill, stationary bicycle or elliptical trainer performed 3 times a week for 12 weeks. The duration of each training session is determined for each woman based on the weekly total energy expenditure goal and workload required to achieve her prescribed exercise heart rate. Women train at 50-60% heart rate reserve (HRR) for the first month and then increase intensity to 60-70% HRR. To ensure that women train at their prescribed exercise heart rates, women wear Polar Heart Rate Monitors while exercising. The exercise counselor overseeing each exercise session records each participant's exercise heart rate every 5-10 minutes to document that she is in her target heart rate range.; Women randomly assigned to the "Usual Activity" group will be asked to continue with their usual physical activities during the study and not make changes. At completion of the intervention, women will have the opportunity to attend a yoga class and receive the yoga booklet, CD, and DVD for home use; or receive a one-month gym membership.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot Flashes; Menopause; Vasomotor symptoms; Yoga; Exercise; Omega-3; Fish oil