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临床试验/NCT04420806
NCT04420806已完成不适用

Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Body composition

研究概览

简要总结

While "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. However, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. In the present project we aimed to determine the effects of 3 months of physical deconditioning due to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly

入排标准

年龄范围
48 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •(early)postmenopausal women, ( normal menopause, 1-5 years post)
  • •Osteopenia and osteoporosis (Bone Mineral Density <-1.0 SD T-Score)

排除标准

  • •BMD <-4.0 SD T-Score
  • •Prevalent clinical, low-trauma fractures
  • •Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids >7.5 mg/d or bisphosphonate therapy); individual case assessment
  • •Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
  • •Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
  • •Other conditions, diseases that exclude exercise training or testing

研究组 & 干预措施

control

Sham Comparator

no exercise intervention that affect the present study outcomes

干预措施: Sham intervention (Other)

HIT-exercise

Active Comparator

13 months of high intensity endurance and resistance exercise - 3 months of exercise break

干预措施: HIT-exercise (Other)

结局指标

主要结局

Body composition

时间窗: From intervention end to 3 months FU

Body composition as determined by Dual-Energy x-Ray Absorptiometry

次要结局

  • Metabolic Syndrome(From intervention end to 3 months FU)
  • Hip-/Leg extension strength(From intervention end to 3 months FU)
  • Bone Mineral Density (BMD)(From intervention end to 3 months FU)
  • Menopausal symptoms(From intervention end to 3 months FU)
  • Back and joint pain(From intervention end to 3 months FU)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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