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Abstract：
BACKGROUND: Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women\'s quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women.
METHODS: A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis.
BACKGROUND: The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences.
BACKGROUND: ChiCTR2300070648.
METHODS: A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis.
BACKGROUND: The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences.
BACKGROUND: ChiCTR2300070648.
摘要：
背景：围绝经期是生殖衰老的关键过渡期。一系列的生理和心理变化可影响围绝经期妇女的生活质量,并进一步威胁其老年成人的健康状况。在中国,有更年期症状的中年女性不到三分之一积极寻求专业医疗服务.关于更年期综合管理的公共卫生意义，本研究旨在调查治疗性生活方式改变（TLM）干预对心脏代谢健康的影响，围绝经期中国女性性功能和健康相关生活质量。
方法：将在中国云南省中医院妇科门诊部进行两组平行的随机对照试验。将招募94名年龄在40至55岁之间的围绝经期妇女进行研究。TLM干预包括四个要素:更年期相关健康教育,饮食指导，盆底肌肉训练和八法五布太极拳锻炼。参与者将被随机分配（1：1）接受12周的TLM干预或通过分层分组分组的常规护理。主要结果是生活质量；次要结果包括性功能和心脏代谢健康。结果指标将在基线和干预后进行评估。探讨干预效果,根据意向治疗分析,将应用线性混合模型来检验两组间各结局随时间的变化.
背景：朱拉隆功大学研究伦理审查委员会（COANo178/66）和云南省中医院医学伦理委员会（IRB-AF-027-2022/02-02）批准了研究方案。将获得所有参与者的书面知情同意书。结果将在同行评审的期刊上发表，并通过会议传播。
背景：ChiCTR2300070648。
方法：将在中国云南省中医院妇科门诊部进行两组平行的随机对照试验。将招募94名年龄在40至55岁之间的围绝经期妇女进行研究。TLM干预包括四个要素:更年期相关健康教育,饮食指导，盆底肌肉训练和八法五布太极拳锻炼。参与者将被随机分配（1：1）接受12周的TLM干预或通过分层分组分组的常规护理。主要结果是生活质量；次要结果包括性功能和心脏代谢健康。结果指标将在基线和干预后进行评估。探讨干预效果,根据意向治疗分析,将应用线性混合模型来检验两组间各结局随时间的变化.
背景：朱拉隆功大学研究伦理审查委员会（COANo178/66）和云南省中医院医学伦理委员会（IRB-AF-027-2022/02-02）批准了研究方案。将获得所有参与者的书面知情同意书。结果将在同行评审的期刊上发表，并通过会议传播。
背景：ChiCTR2300070648。
