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临床试验/NCT02850731
NCT02850731撤回不适用

Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult

University Hospital, Toulouse0 个研究点开始时间: 2019年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Evolution of physical performances using the Score Short Physical Performance Battery

研究概览

简要总结

Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.

Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.

Two phases for each group (Intervention/Control):

Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.

Blinded evaluations will be performed at 6 weeks and at 6 months for each group.

The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.

详细描述

Background

The process of aging causes a progressive decline in functional capacities. Maintaining physical fitness appears to be an important factor to fight against frailty (40% more frailty in people > 65 years old), a condition that causes loss of independence but that is clinically reversible.

Fragility is a condition that associates: slowed walking speed, sedentary lifestyle, weight loss, muscle weakness and low energy levels. It is therefore correlated with physical performance.

Purpose

A number of studies have demonstrated the benefit of physical activity in frail older people. Levels of adherence to physical activity programs are not well known but low adherence decreases the positive effects of the intervention. It seems therefore interesting to suggest another approach that integrates innovative technology (plate-forme Hu360®) that can improve the clinical condition of the frail older person, as well as levels of adherence.

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
Single (Outcomes Assessor)

入排标准

年龄范围
70 Years 至 89 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged between 70-89 years old.
  • Living at home
  • Having at least one fragility criteria (from Fried's 5 criteria), which must include the sedentary criteria.
  • Having a Score SPPB <10
  • Independent mobility
  • MMSE score ≥18
  • BMI between 18 and 40
  • Informed consent to participate in a randomized control trial (physical activity using the motorized platform, Hu360® vs a traditional physical activity program).

排除标准

  • Severe cardiac problems
  • Degenerative neurological conditions
  • Hip/Knee joint replacement less than 6 months before the study.
  • Psychotic disorders or bipolar disorder.
  • Patients who already participate in a regular physical activity program or follow a rehabilitation program.
  • Patients under legal protection and / or unable to give informed consent
  • Already participating in a clinical trial or a study with a physical activity program.

结局指标

主要结局

Evolution of physical performances using the Score Short Physical Performance Battery

时间窗: 6 months

Evolution of physical performances within 6 months estimated by the Score Short Physical Performance Battery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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