MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
6 other identifiers
interventional
355
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 22, 2014
August 1, 2014
1.5 years
August 9, 2010
August 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and bother of hot flashes measured by self-report diaries.
12 weeks
Secondary Outcomes (2)
Frequency of hot flashes measured by objective biological marker.
12 weeks
Anxiety, health- and menopause-related quality of life, depressed mood, and sleep (subjective by diaries and objective by sleep watch worn on wrist).
12 weeks
Study Arms (6)
Placebo
PLACEBO COMPARATOROmega-3
EXPERIMENTALYoga
EXPERIMENTALExercise
EXPERIMENTALUsual Activity 1
OTHERUsual Activity 1 and Usual Activity 2 arms will be compared to the Yoga and Exercise arms.
Usual Activity 2
OTHERUsual Activity 1 and Usual Activity 2 arms will be compared to the Yoga and Exercise arms.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Females aged 40-62 years.
- Menopausal, including:
- Women who have had a bi-lateral oophorectomy;
- Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval of 60 or more days in the past 12 months;
- Women without a uterus and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL;
- Women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL.
- Having bothersome hot flashes and/or night sweats.
- In general good health as determined by medical history, blood pressure, and heart rate:
- Absence of uncontrolled hypertension greater than 160/100;
- Resting heart rate less than 110 beats per minute;.
- No history of myocardial infarction, angina, or cerebrovascular events;.
- No history of liver, renal disease, or uncontrolled seizure disorder.
- Absence of uncontrolled metabolic disease (such as diabetes) and absence of current infectious disease (such as acute symptoms of mononucleosis) that would put staff and other participants at risk.
- Signed informed consent.
You may not qualify if:
- 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);
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Institute on Aging (NIA)collaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- Office of Research on Women's Health (ORWH)collaborator
- Nordic Naturalscollaborator
Study Sites (3)
Kaiser Division of Research
Oakland, California, 94611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Group Health Research Institute
Seattle, Washington, 98101, United States
Related Publications (9)
Sternfeld B, LaCroix A, Caan BJ, Dunn AL, Newton KM, Reed SD, Guthrie KA, Booth-LaForce C, Sherman KJ, Cohen L, Freeman MP, Carpenter JS, Hunt JR, Roberts M, Ensrud KE. Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience. Contemp Clin Trials. 2013 May;35(1):25-34. doi: 10.1016/j.cct.2013.02.009. Epub 2013 Feb 24.
PMID: 23462342BACKGROUNDDiem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
PMID: 32701665DERIVEDGuthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
PMID: 29165623DERIVEDJones SM, Guthrie KA, LaCroix AZ, Sternfeld B, Landis CA, Reed SD, Dunn A, Caan B, Cohen LS, Hunt J, Newton KM. Is heart rate variability associated with frequency and intensity of vasomotor symptoms among healthy perimenopausal and postmenopausal women? Clin Auton Res. 2016 Feb;26(1):7-13. doi: 10.1007/s10286-015-0322-x. Epub 2015 Dec 21.
PMID: 26691637DERIVEDGuthrie KA, LaCroix AZ, Ensrud KE, Joffe H, Newton KM, Reed SD, Caan B, Carpenter JS, Cohen LS, Freeman EW, Larson JC, Manson JE, Rexrode K, Skaar TC, Sternfeld B, Anderson GL. Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms. Obstet Gynecol. 2015 Aug;126(2):413-422. doi: 10.1097/AOG.0000000000000927.
PMID: 26241433DERIVEDNewton KM, Reed SD, Guthrie KA, Sherman KJ, Booth-LaForce C, Caan B, Sternfeld B, Carpenter JS, Learman LA, Freeman EW, Cohen LS, Joffe H, Anderson GL, Larson JC, Hunt JR, Ensrud KE, LaCroix AZ. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial. Menopause. 2014 Apr;21(4):339-46. doi: 10.1097/GME.0b013e31829e4baa.
PMID: 24045673DERIVEDCohen LS, Joffe H, Guthrie KA, Ensrud KE, Freeman M, Carpenter JS, Learman LA, Newton KM, Reed SD, Manson JE, Sternfeld B, Caan B, Freeman EW, LaCroix AZ, Tinker LF, Booth-Laforce C, Larson JC, Anderson GL. Efficacy of omega-3 for vasomotor symptoms treatment: a randomized controlled trial. Menopause. 2014 Apr;21(4):347-54. doi: 10.1097/GME.0b013e31829e40b8.
PMID: 23982113DERIVEDSternfeld B, Guthrie KA, Ensrud KE, LaCroix AZ, Larson JC, Dunn AL, Anderson GL, Seguin RA, Carpenter JS, Newton KM, Reed SD, Freeman EW, Cohen LS, Joffe H, Roberts M, Caan BJ. Efficacy of exercise for menopausal symptoms: a randomized controlled trial. Menopause. 2014 Apr;21(4):330-8. doi: 10.1097/GME.0b013e31829e4089.
PMID: 23899828DERIVEDNewton KM, Carpenter JS, Guthrie KA, Anderson GL, Caan B, Cohen LS, Ensrud KE, Freeman EW, Joffe H, Sternfeld B, Reed SD, Sherman S, Sammel MD, Kroenke K, Larson JC, Lacroix AZ. Methods for the design of vasomotor symptom trials: the menopausal strategies: finding lasting answers to symptoms and health network. Menopause. 2014 Jan;21(1):45-58. doi: 10.1097/GME.0b013e31829337a4.
PMID: 23760428DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Z. LaCroix, PhD
Fred Hutchinson Cancer Center
- PRINCIPAL INVESTIGATOR
Garnet Anderson, PhD
Fred Hutchinson Cancer Center
- PRINCIPAL INVESTIGATOR
Susan D Reed, MD, MPH
University of Washington/Group Health Research Institute
- PRINCIPAL INVESTIGATOR
Katherine M Newton, PhD
Group Health Research Institute
- PRINCIPAL INVESTIGATOR
Bette Caan, DrPH
Kaiser Permanente
- PRINCIPAL INVESTIGATOR
Barbara Sternfeld, PhD
Kaiser Permanente
- PRINCIPAL INVESTIGATOR
Janet Carpenter, PhD, RN, FAAN
Indiana University School of Medicine
- PRINCIPAL INVESTIGATOR
Hadine Joffee, MD, MSc
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Lee Cohen, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 10, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 22, 2014
Record last verified: 2014-08