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临床试验/NCT03622554
NCT03622554已完成不适用

Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2018年8月9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
入组人数
269
试验地点
1
主要终点
Incidence of falls at 12 months

研究概览

简要总结

Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal

研究设计

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

入排标准

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

入选标准

  • •Patient aged 65 and over,
  • •Presence of at least one chronic pathology justifying treatment and cure
  • •Subject having a history of fall in the last year (at least one fall)
  • •Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder

排除标准

  • •Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
  • •Patient under the protection of justice, under guardianship or curatorship

研究组 & 干预措施

Control arm

No Intervention

Curist taking a spa treatment of 3 weeks in the usual conditions for each Center

Intervention

Experimental

Addition to the usual cure: -12 adapted physical activity (APA) sessions of 60 minutes to improve the balance , muscular strength, endurance and suppleness without creating additional fatigue for the curists

  • personalized therapeutic patient education (ETP) with an individual assessment at the beginning of the treatment (1h), 3 group sessions (1h30) and an end-of-cure interview (1h) and an educational follow-up by phone at 3, 6 and 12 months

干预措施: Adapted Physical Activity (APA) (Other)

Intervention

Experimental

Addition to the usual cure: -12 adapted physical activity (APA) sessions of 60 minutes to improve the balance , muscular strength, endurance and suppleness without creating additional fatigue for the curists

  • personalized therapeutic patient education (ETP) with an individual assessment at the beginning of the treatment (1h), 3 group sessions (1h30) and an end-of-cure interview (1h) and an educational follow-up by phone at 3, 6 and 12 months

干预措施: Therapeutic Patient Education (ETP) (Other)

结局指标

主要结局

Incidence of falls at 12 months

时间窗: 12 months

To evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and therapeutic patient education ( ETP), followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal Center

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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