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临床试验/NCT05798169
NCT05798169已完成不适用

Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2023年1月5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
274
试验地点
2
主要终点
Change from baseline 4 meter Gait Speed Test

研究概览

简要总结

Sarcopenia characterised by loss of muscle mass, muscle strength and physical performance burdens many older adults since the condition is related to functional decline. Periods of inactivity such as during hospitalisation leads to further functional decline. It has been reported that the loss of muscle mass associated with sarcopenia not only entails a decrease in muscle mass but also changes in muscle architecture. Knowledge on changes in muscle architecture is essential since it is one of the most important determinants on muscle strength and thus physical performance. The main objective of this study is to investigate changes in muscle architecture and physical performance during acute hospitalisation and after discharge in older adults and subsequently the effectiveness of resistance training of the lower limb during acute hospitalisation. If successful, our study could have a great impact on the individual, as well as societal level, due to a better understanding of the factors related to sarcopenia and the prevention of functional decline as a result of hospitalisation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ≥65 years of age
  • Able to ambulate before hospitalization (with/without assistance)
  • Able to communicate with the research team
  • Expected length of stay ≥2 days
  • Residing on Funen

排除标准

  • Able to ambulate without assistance during current hospitalization
  • Known severe dementia
  • Positive Confusion and Assessment Method score
  • Patients who have received less than 3 resistance training sessions at discharge
  • Terminal illness
  • Recent major surgery or lower extremity bone fracture in the last 3 months
  • Conditions contradicting use of ROBERT(unstable vertebral-, pelvic, or lower extremity fractures
  • high intracranial pressure
  • pressure ulcers or risk of developing pressure ulcers due to fragile skin
  • patients with medical instability)
  • Metastases at femur hip
  • Deemed not suitable for resistance training sessions with the robot by the healthcare professional.

结局指标

主要结局

Change from baseline 4 meter Gait Speed Test

时间窗: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

Physical performance evaluated by the 4m Gait Speed test

Change from baseline B-mode ultrasonography

时间窗: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up

Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.

次要结局

  • Change from baseline 30s Chair Stand test(Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week))
  • Length of hospital stay(Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week))
  • Mortality(Baseline (day of hospitalization) to 3-months follow-up)
  • Change from baseline Barthel-Index 100 (Shahs version)(Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week))
  • Individual level of physiotherapy(Baseline (day of hospitalisation) to 3-months follow-up)
  • Change from baseline Bioimpedance(Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week))
  • Unplanned hospitalisation(Day of discharge from hospital to 3-months follow-up)

研究者

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

Lisbeth Rosenbek Minet

Professor

University of Southern Denmark

研究点 (2)

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