Objective: This study aims to determine the efficacy of exercise training for alleviating vasomotor and other menopausal symptoms.
Methods: Late perimenopausal and postmenopausal sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted in three sites: 106 women randomized to exercise and 142 women randomized to usual activity. The exercise intervention consisted of individual facility-based aerobic exercise training three times per week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and on weeks 6 and 12. Intent-to-treat analyses compared between-group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index and Pittsburgh Sleep Quality Index), and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire).
Results: At the end of week 12, changes in VMS frequency in the exercise group (mean change, −2.4 VMS/d; 95% CI, −3.0 to −1.7) and VMS bother (mean change on a four-point scale, −0.5; 95% CI, −0.6 to −0.4) were not significantly different from those in the control group (−2.6 VMS/d; 95% CI, −3.2 to −2.0; P = 0.43; −0.5 points; 95% CI, −0.6 to −0.4; P = 0.75). The exercise group reported greater improvement in insomnia symptoms (P = 0.03), subjective sleep quality (P = 0.01), and depressive symptoms (P = 0.04), but differences were small and not statistically significant when P values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only.
Conclusions: These findings provide strong evidence that 12 weeks of moderate-intensity aerobic exercise do not alleviate VMS but may result in small improvements in sleep quality, insomnia, and depression in midlife sedentary women.
From the 1Division of Research, Kaiser Permanente, Oakland, CA; 2Fred Hutchison Cancer Research Center, Seattle, WA; 3University of Minnesota and Minneapolis VA Health Care System, Minneapolis, MN; 4Klein Buendel Inc, Denver, CO; 5Division of Nutritional Sciences, Cornell University, Ithaca, NY; 6School of Nursing, Indiana University, Indianapolis, IN; 7Group Health Research Institute, Seattle, WA; 8University of Washington, Seattle, WA; 9Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA; 10Massachusetts General Hospital, Harvard University, Boston, MA; and 11National Institute for Fitness and Sport, Indianapolis, IN.
Received April 5, 2013; revised and accepted May 28, 2013.
K.A.G. had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of data analysis. All authors made substantial contributions to the study and this manuscript. None was compensated for manuscript preparation.
Funding/support: This study was supported by a cooperative agreement issued by the NIA, in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, and the Office of Research and Women’s Health, and by NIA grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, and U01AG032700. At the Indiana University site, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute, funded in part by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award. The ω-3 study supplement (ω-3, n − 3, or polyunsaturated fatty acids) was manufactured as eicosapentaenoic acid and donated, with matching placebo, by Nordic Naturals (Watsonville, CA).
Clinical trial registration: NCT01178892 (ClinicalTrials.gov).
Financial disclosure/conflicts of interest: K.E.E. serves as a consultant to a data monitoring committee for Merck, Sharp, and Dohme. A.L.D. is employed at Klein Buendel Inc. K.M.N. has received research support from Integrated Diagnostics Inc. E.W.F. has received research support from Forest Laboratories Inc. and Bionovo Inc. L.S.C. has received research support from Astra-Zeneca Pharmaceuticals, Bristol-Myers Squibb, Cephalon Inc, GlaxoSmithKline, Ortho-McNeil Janssen, and Sunovion Pharmaceuticals Inc, and has served as adviser/consultant to Noven Pharmaceuticals. H.J. has received grant support from Cephalon/Teva, serves on the advisory board of Noven, and has consulted for Sunovion. M.R. has received grant and travel support from Indiana University/Purdue University Indianapolis. All other authors have no direct conflicts of interest or financial disclosures relevant to this manuscript.
Address correspondence to: Barbara Sternfeld, PhD, Division of Research, Kaiser Permanente, 2000 Broadway, Oakland, CA 94612. E-mail: Barbara.firstname.lastname@example.org