Background: During the transition to menopause, women experience different psychological, hormonal, and physical alterations that can affect their health. Physical activity is considered an important strategy in the prevention and control of such changes.
Aim: To evaluate the short-term effect of an intensive intervention, based on a combined exercise programme using a Smartband, on the increase of physical activity and the decrease of sedentary lifestyle in postmenopausal and inactive women.
Design: Randomized clinical trial with two parallel groups.
Methods: In total, 100 postmenopausal and inactive women aged 45-70 years will be randomized to a control group or an intervention group. Both groups will be given a standardized advice about physical activity. The intervention group will carry out a supervised 12-week programme of aerobic and muscle strengthening exercise; moreover, the women in this group will receive a Smartband to assist them in the intervention. The main result will be the increase of physical activity and the decrease of sedentary lifestyle, measured with an accelerometer for 1 week. This programme will be conducted by a nurse and a physiotherapist of the health centre. The study was approved by the Drug Research Ethics Committee of the Salamanca Health Service on 15 February 2019. The project was funded by the Autonomous Government of Castile and Leon and by the Carlos III Health Institute.
Discussion: Physical activity is an important strategy to consider when addressing the changes caused by menopause, although the current evidence shows that further studies should be carried out with longer intervention periods and new technologies.
Impact: This study will allow determining the effectiveness of the intensive intervention based on a combined programme of physical activity using a Smartband in postmenopausal and inactive women.
Trials registration: ClinicalTrials.gov with identifying code NCT03872258.
背景: 更年期过渡阶段, 女性会经历不同的心理、激素和生理变化, 而此类变化可能会对她们的健康造成影响。人们认为, 可通过体力活动预防和控制此类变化。 目的: 使用Smartband, 并以综合锻炼计划为基础, 评估强化干预对绝经后女性和缺少运动的女性增加体力活动和减少久坐生活方式的短期影响 设计: 两个平行组的随机临床试验。 方法: 共有100名年龄介于45岁和70岁之间女性参与, 此类女性或已绝经或缺少运动, 并且将被随机分到对照组或干预组中。干预组将接受为期12周的有氧和肌肉强化训练; 此外, 该组的女性将获得一个智能手环, 以便协助其进行干预。主要结果为增加体力活动和减少久坐, 在此情况下, 用加速度计测量1周。此项目将由保健中心的一名护士和一名理疗师负责。本研究于2019年2月15日获得萨拉曼卡卫生局药物研究伦理委员会的批准。此项目由卡斯蒂利亚和利昂自治政府以及卡洛斯三世卫生研究所供资。 讨论: 如需应对更年期引起的变化, 应增强体力活动, 此为一项重要策略, 尽管当前证据表明, 应通过更长的干预期和新技术开展进一步的研究。 影响: 本研究将有助于确定绝经后女性和和缺少运动的女性使用Smartband进行体力活动的综合方案, 及在此基础上进行强化干预的有效性。.
Keywords: exercise; health education; mHealth; nursing; postmenopause.
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