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临床试验/NCT04861701
NCT04861701Unknown不适用

Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise : A Randomized Controlled Trial

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Hot flush frequency

研究概览

简要总结

This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.

详细描述

Hot flush (HF) is the most common symptom among menopausal syndrome and can significantly affect women's quality of life. Considering the risk of hormone therapy, the behavioral therapies have been proposed for the alternative treatment of HF. However, the exercise prescription for women with HF is controversial. Previous studies show the inconsistent effect of aerobic exercise on HF, and a moderate-to-high intensity exercise seems to aggravate HF frequency and severity. Recent studies have shown that static stretching exercise could improve HF in middle-aged women, but the related research is quite few, and the physiological mechanism as well as predictors for responders who can benefit from stretching exercise are still not clear. The knowledge of predictors for responders will provide clinicians and clients with HF symptoms to choose static stretching exercise as their treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 20-65 years old.
  • With hot flashes.
  • No current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months.
  • With ability to follow instructions of stretching exercise.

排除标准

  • SBP >160 mmHg or DBP >100 mmHg
  • Medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease.
  • Any medical condition limiting the ability to participate the exercise.

结局指标

主要结局

Hot flush frequency

时间窗: week 4 of intervention period (post-intervention)

Frequency of hot flush (time/day)

Hot flush score

时间窗: week 4 of intervention period (post-intervention)

The sum of mean hot flushes multiplied by severity (mild x 1, moderate x 2, severe x 3)

次要结局

  • Vascular endothelial function(week 4 of intervention period (post-intervention))
  • Hot Flush Related Daily Interference Scale (HFRDIS)(week 4 of intervention period (post-intervention))
  • Percentage of low frequency (LF%)(week 4 of intervention period (post-intervention))
  • Percentage of high frequency (HF%)(week 4 of intervention period (post-intervention))
  • LF/HF ratio (L/H ratio)(week 4 of intervention period (post-intervention))
  • Standard deviation of NN intervals (SDNN)(week 4 of intervention period (post-intervention))
  • Absolute total power(week 4 of intervention period (post-intervention))
  • Low frequency in normalized unit (LF norm)(week 4 of intervention period (post-intervention))
  • High frequency in normalized unit (HF norm)(week 4 of intervention period (post-intervention))
  • Muscle flexibility of upper extremities(week 4 of intervention period (post-intervention))
  • Muscle flexibility of lower extremities(week 4 of intervention period (post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Wun Tsai

Associate Professor

National Yang Ming Chiao Tung University

研究点 (2)

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