Background: Menstrual disorders were not reported as a possible secondary effect in any of the clinical trials for the SARS-CoV-2 vaccines. Aim: To describe the prevalence of perceived premenstrual and menstrual changes after COVID-19 vaccine administration. Design: Cross-sectional study. Methods: A total of 14,153 women (mean age 31.5 ± 9.3 years old) who had received the full course of vaccination at least three months earlier were included in this cross-sectional study. Data including the type of vaccine administered, perceived changes in the amount and duration of menstrual bleeding, presence of clots, cycle length, and premenstrual symptoms were collected through a retrospective online survey from June to September 2021. Results: Of the women who participated in this study, 3136 reported no menstrual changes and 11,017 (78% of the study sample) reported experiencing menstrual cycle changes after vaccination. In summary, women who reported menstrual changes after vaccination were older (overall p < 0.001) and slightly more smokers ( p = 0.05) than women who did not report any changes. The most prevalent changes in relation to premenstrual symptoms were increased fatigue (43%), abdominal bloating (37%), irritability (29%), sadness (28%), and headaches (28%). The most predominant menstrual changes were more menstrual bleeding (43%), more menstrual pain (41%), delayed menstruation (38%), fewer days of menstrual bleeding (34.5%), and shorter cycle length (32%). Conclusion: Women vaccinated against COVID-19 usually perceive mild menstrual and premenstrual changes. Future studies are warranted to clarify the physiological mechanisms behind these widely reported changes.

BackgroundThe al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia.Methods/DesignOne hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n = 60), a water-based exercise intervention group (n = 60) or a land-based exercise intervention group (n = 60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention) on the studied variables.DiscussionOur study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.Trial registrationClinicalTrials.gov ID: NCT01490281

Objective: To investigate the influence of a supervised multicomponent exercise training program on menopause-related symptoms, particularly vasomotor symptoms (VMS), in middle-aged women.Methods: A total of 112 middle-aged women (mean age 52 AE 4 y old, age range 45-60 y) from the FLAMENCO project (exercise [n ¼ 59] and counseling [n ¼ 53] groups) participated in this randomized controlled trial (perprotocol basis). The exercise group followed a multicomponent exercise program composed of 60-minute sessions 3 days per week for 16 weeks. The 15-item Cervantes Menopause and Health Subscale was used to assess the frequency of menopause-related symptoms.Results: After adjusting for body mass index and Mediterranean diet adherence, the subscales measuring menopause-related symptoms and VMSs decreased 4.6 more in the exercise group compared to the counseling group (between-group differences [B]: 95% CI: -8.8 to -0.2; P ¼ 0.040). The exercise group also showed significant improvements in the subscales of couple relationships (between-group differences [B]: -1.87: 95% CI: -3.29 to -0.45; P ¼ 0.010), psychological state (between-group differences [B]: -2.3: 95% CI: -5 to -0.2; P ¼ 0.035), and VMSs (between-group differences [B]: -4.5: 95% CI: -8.8 to -0.2; p ¼ 0.040) in the Cervantes Menopause and Health Subscale compared with the counseling group.Conclusions: A 16-week multicomponent physical exercise program showed a positive effect on menopauserelated symptoms especially in couple relationships, psychological state, and VMS, among 45 to 60 year old women.

Objective: To analyze the influence of a supervised concurrent exercise program on emotional well-being and emotional distress in middle-aged women. Methods: This randomized controlled trial included 150 middle-aged women recruited for the FLAMENCO project. Participants were allocated into counseling (n = 75) or exercise (n = 75) groups. The counseling group attended conferences on healthy lifestyle (including diet and physical activity topics). The exercise group followed a 60-min concurrent (aerobic + resistance) exercise training 3 days/wk for 16 weeks. Emotional health was assessed with the Positive and Negative Affect Schedule (PANAS) in two diverse timeframes, state (PANAS-S) and trait (PANAS-T) ranging from 10 to 50, where higher scores reflect greater affective emotional health/experience (positive affect subscale) and greater emotional distress (negative affect subscale). The differences between the counseling and exercise groups in PANAS were analyzed by linear regression. Results: The total number of women for the per-protocol analyses was 111 divided into the counseling (n = 53) and exercise (n = 58) groups. After adjusting for body mass index and Mediterranean diet adherence, PANAS-S and PANAS-T-positive affect scores increased by 3.81 and 3.02, respectively, in the exercise group whereas they decreased by 0.15 and increased by 0.51 in the counseling group (both, P < 0.05). PANAS-T negative affect decreased by 4.10 in the exercise group whereas only decreased by 0.9 in the counseling group (P < 0.05). Conclusion: A 16-week concurrent exercise program improved emotional experience in middle-aged women. Specifically, women in the exercise group significantly improved their emotional well-being and emotional distress through greater changes in positive affect and negative affect compared with the counseling group.

Objectives It is widely acknowledged that the experience of pain is promoted by both genetic susceptibility and environmental factors such as engaging in physical activity (PA) and that pain-related cognitions are also important. Thus, the purpose of the present study was to test the association of 64 polymorphisms (34 candidate-genes) and the gene-gene, gene-PA, and gene-sedentary behaviour interactions with pain and pain-related cognitions in women with fibromyalgia. Methods Saliva samples from 274 women with fibromyalgia (aged 51.7 ± 7.7 years) were collected for extracting DNA. We measured PA and sedentary behaviour by accelerometers for a week, pain with algometry and questionnaires, and pain-related cognitions with questionnaires. To assess the robustness of the results, a meta-analysis was also performed. Results The rs6311 and rs6313 polymorphisms (HTR2A) were individually related to algometer scores. The interaction of rs4818 (COMT) and rs1799971 (OPRM1) was related to pain catastrophizing. Five gene-behaviour interactions were significant: the interactions of sedentary behaviour with rs1383914 (ADR1A), rs6860 (CHMP1A), rs4680 (COMT), rs165599 (COMT) and rs12994338 (SCN9A) on bodily pain subscale of the SF-36. Furthermore, the meta-analysis showed an association between rs4680 (COMT) and severity of fibromyalgia symptoms (codominant model, p-value: 0.032). Conclusion The HTR2A gene (individually), COMT and OPRM1 gene-gene interaction, and the interactions of sedentary behaviour with ADRA1A, CHMP1A, COMT, and SCN9A genes were associated with pain-related outcomes. Collectively, findings from the present study indicate a modest contribution of genetics and gene-sedentary behaviour interaction to pain and pain catastrophizing in women with fibromyalgia. Future research should examine whether reducing sedentary behaviour is particularly beneficial for reducing pain in women with genetic susceptibility to pain.