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临床试验/NCT06659484
NCT06659484进行中(未招募)不适用

Evaluation and Changes of Disability Mobility Risk Factors in Older Adults Aged 70 and Over and Integrated in "Well on My Legs" Prevention Program.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2016年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,600
试验地点
1
主要终点
SPPB (Short Physical Performance Battery)

研究概览

简要总结

The percentage of people aged over 80 will double in 25 years, reaching 10% of the population. This means that care practices for older adults will have to be adapted. Furthermore, disability-free life expectancy at 65 years old is 10.4 years, well below the overall life expectancy of 24.4 years for women and 19.1 years for men. Beneficiaries of the personalized autonomy allowance would increase by 60%, representing a major cost. Among the various factors predictive of loss of autonomy, loss of mobility and muscle weakness are major components (OR = 3.28 at 3 years) according to data from the latest meta-analyses. These two disability-causing factors are also responsible for multiple adverse events (falls, fractures, etc.), impaired quality of life and increased mortality. The only components accessible to preventive action and with a proven track record are exercise and nutrition. Despite a high level of evidence on the improvement of physical abilities and muscle strength, these programs are still not sufficiently implemented in practice. Indeed, neither the identification of seniors at risk of mobility disability, nor preventive actions are usually carried out in primary care. Setting up a care path, with personalized intervention combining, after identification, learning of good physical activity practices by a specialized kinesiologist and nutritional advice, followed by supervised exercise, for subjects at risk, is a public health imperative. The "Well on my legs" prevention program, supported by Hospices Civils de Lyon and present since 2014 in the Rhône region, is a concrete solution to this major public health challenge.

Analyses will be based on data collected through participant assessments during the "Well on my legs" prevention program. The analyses will make it possible to assess the risk factors of mobility disability in older adults at the start (T0) and at the end of the program (T3+12months), with the aim of improving the program's efficiency and evaluating its effectiveness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patient covered by the "Well on my legs" program for primary and secondary prevention of mobility disability.
  • At least 1 of the following signs:
  • Difficulty carrying a loaded shopping basket (load approx. 4.5 kg)
  • Difficulty getting up from a chair without using arms
  • Difficulty climbing a flight of stairs (10 steps)
  • Difficulty moving around
  • Slow gait speed
  • Difficulty walking more than 400 meters without stopping
  • Walking time < 30 min/d
  • Fatigue during modest physical effort: shopping, housework,
  • Fear of falling and/or at least one fall in the past year
  • Recent involuntary weight loss: weight loss ≥ 5% in 1 month or BMI < 22kg/m2

排除标准

  • - Patient who has not given consent to participate
  • Patient under guardianship or legal protection in retrospective phase
  • Patient with a locomotor handicap or SPPB <5
  • Patient with a life expectancy of less than 12 months
  • Patient with severe cognitive impairment
  • Patient with exercise contraindications

结局指标

主要结局

SPPB (Short Physical Performance Battery)

时间窗: Change in the SPPB Score at 3 months of intervention and 1 year after

Functional status is assessed by the overall Short Physical Performance Battery (SPPB) score, based on three components: gait speed, chair raising and balance tests.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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