运动即良药：应对更年期症状的非药物疗法
The aim of this clinical trial is to evaluate the effects of different forms of physical exercise in women experiencing menopausal symptoms. Specifically, the project investigates the effects of: (1) strength training on women's perceived menopausal symptoms; (2) dance-based exercise on women's perceived menopausal symptoms; and (3) adherence to structured, digital home-based exercise programs.
The following research questions will be addressed within the framework of the project:
Does regular strength training reduce women's perceived menopausal symptoms?
To what extent does strength training influence menopausal symptoms and sleep quality in women?
What is the level of adherence to a digital, home-based strength training program among women with menopausal symptoms?
Does regular dance-based physical activity reduce women's perceived menopausal symptoms?
To what extent does dance-based physical activity influence menopausal symptoms and sleep quality in women?
What is the level of adherence to a digital, home-based dance exercise program among women with menopausal symptoms?
Which exercise protocol-strength training or dance-based exercise-has the greatest effect on perceived menopausal symptoms?
The researchers will compare a digital, home-based strength training program with a digital, home-based dance exercise program, as well as with a control group, to determine which type of exercise has the greatest effect on menopausal symptoms and sleep quality.
Participants will:
Perform either dance-based exercise or strength training for 8 weeks, three times per week, following a structured program of approximately 30 minutes per session, or participate as part of the control group.
Complete validated questionnaires assessing menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality, both before and after the intervention.
Maintain a training diary to monitor adherence and progression, including increases in training intensity
研究概览
详细说明
This clinical trial will be conducted as a randomized controlled trial, in which participants will be randomly assigned to either an intervention group or a control group. The study will begin with a pilot phase including 45 menopausal women, who will be randomly allocated to one of three groups: (1) strength training intervention (n = 15); (2) dance-based training intervention (n = 15); or (3) control group (n = 15).
Following completion of the pilot study, a full-scale intervention trial will be conducted. The sample size for the main study will be determined by a power calculation based on the results obtained from the pilot phase.
The study will begin with an assessment of participants' menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality. These outcomes will be measured using the Menopause Rating Scale (MRS) and the Pittsburgh Sleep Quality Index (PSQI).The training protocols will be conducted over an 8-week period, with sessions performed three times per week according to a structured program lasting approximately 30 minutes per session. Two weeks after completion of the intervention, participants will be reassessed using the same instruments, with questionnaires distributed electronically via SurveyMonkey®.
The intervention will begin with a digital introductory meeting, during which participants will receive information materials on menopausal symptoms and a detailed review of the training program and study procedures. Participants in the control group will continue their usual daily activities without any prescribed intervention throughout the 8-week study period. Participants in the control group will be assessed using both instruments on two occasions, with an 8-week interval between assessments. Upon completion of the study, control group participants will be offered access to both intervention programs, as well as the results from Studies 1 and 2.
Throughout the study period, participants will be instructed not to introduce any additional forms of exercise or make changes to existing physical activity habits. The full-scale intervention is planned to be conducted over a 15-week period with a potentially larger sample size.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Kalmar、瑞典、391 82
- 招聘中
- Sofia Ryman Augustsson
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接触：
- Sofia Ryman Augustsson, PhD
- 电话号码：+46480-44 63 58
- 邮箱：sofia.rymanaugustsson@lnu.se
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Biological female sex
- Age 45-55 years
- Experiencing menopausal symptoms, defined as irregular or altered menstruation plus at least one of the following:
- Hot flashes or sweating
- Sleep problems
- Mood swings or depression
- Dry mucous membranes
- Recurrent urinary tract infections or overactive bladder
- Joint pain
- Decreased libido
- Weight gain
Exclusion Criteria:
- Have taken medication or natural remedies for menopausal symptoms in the past 2 months
- Menopause due to illness or surgical intervention
- Medical conditions that contraindicate participation in the exercise intervention
- Engaged in physical activity for ≥150 minutes per week, including ≥ 75 minutes at high intensity
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
No intervention |
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实验性的：Strength training
Strength training intervention. |
The strength training intervention consists of an 8-week program performed 3 times per week, with sessions lasting ~30 minutes. Designed by a licensed physiotherapist, the program targets major muscle groups and includes a warm-up followed by structured exercises. Training uses body weight and simple household equipment, such as chairs and filled water bottles, at an intensity of 8-12 repetition maximum. Each exercise has three to four difficulty levels. Before starting, participants test and select an appropriate level for each exercise to ensure correct intensity. Participants perform at a level allowing at least eight repetitions and progress once they can complete more than twelve. This enables individualized, progressive training. After each session, participants record the difficulty level and number of repetitions in a training diary. For the full-scale intervention, exercise selection, intensity, and volume may be adjusted, and the program will be extended to 15 weeks. |
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实验性的：Dance-based training
Dance-based training intervention. |
Participants in the dance-based intervention will exercise three times per week at moderate intensity, following a structured 30-minute program performed individually at home via pre-recorded sessions. After each session, participants will complete a training diary and rate perceived exertion using the Borg RPE scale (6-20), targeting at least moderate intensity (RPE ≥ 14), adjusting effort accordingly. The program was developed and recorded by a licensed physiotherapist, pilot-tested with a small group, and reviewed by a supervising expert who provided feedback. Participants can ask questions and receive guidance on performing the exercises. For the full-scale intervention, exercise selection, intensity, and volume may be refined, and the program will be conducted over 15 weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Menopause Rating Scale (MRS)
大体时间：2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
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The Menopause Rating Scale (MRS) consists of 11 items grouped into three dimensions:
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2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
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Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and a global score is calculated by summing the components. Higher scores indicate poorer sleep quality. The Pittsburgh Sleep Quality Index (PSQI) generates a global score ranging from 0 to 21, where a score greater than 5 typically indicates poor sleep quality. This threshold serves as a clinical benchmark, with higher scores correlating with increased severity of sleep disturbances. |
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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