跳至主要内容
临床试验/NCT04997447
NCT04997447已完成不适用

Enforced Reduction in Physical Activity and Recovery in Older Adults

University of Jyvaskyla2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Lean leg mass

研究概览

简要总结

Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
70 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 70-80 years,
  • community-dwelling,
  • able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
  • BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
  • no serious cardiovascular or musculoskeletal disease,
  • no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
  • non-smoker,
  • provision of informed consent.

排除标准

  • Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
  • unwilling/unable to track daily step counts using accelerometer,
  • excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
  • difficulty in communication due to severe vision or hearing problems
  • unwilling to provide consent or accept randomization into either study group

结局指标

主要结局

Lean leg mass

时间窗: 6 weeks

DXA-measured total lean mass of the legs

次要结局

  • Walking economy(6 weeks)
  • Whole-body fat mass(6 weeks)
  • Maximum isometric leg extension force(6 weeks)
  • Short Physical Performance Battery (SPPB)(6 weeks)
  • Blood pressure(6 weeks)
  • HOMA indices(6 weeks)
  • White blood cell respiration(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Enforced Reduction in Physical Activity and Recovery... | 临床试验