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临床试验/NCT04916964
NCT04916964Unknown不适用

Effects of the Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) on Balance, Mobility, and Executive Functions in Persons With Alzheimer's Disease: Protocol for an Exploratory Pilot Study

HES-SO Valais-Wallis2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Sit to stand

研究概览

简要总结

The aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted T&E home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable Alzheimer's Disease.

详细描述

Primary and secondary outcomes will be measured at T0 (one week before the begin of the intervention) and T1, (one week after the eight weeks of the intervention) at home of the participants.

Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session.

Twelve participants will take part at this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Must living at their own home,
  • Clinical diagnosis of mild or probable Alzheimer's Disease,
  • Must be medical stable,
  • Must be able to walk with or without assistive device without physical assistance of another person,
  • Must be able to follow one-step commands,
  • Family caregiver's must agree to participate at the training sessions.

排除标准

  • Severe vision and verbal impairment,
  • Any serious orthopaedic condition,
  • Any major neurologic or musculoskeletal comorbidity that might affect their functional mobility,
  • Any limiting cardiac or pulmonary condition.

结局指标

主要结局

Sit to stand

时间窗: 8 weeks

Five Time Sit to Stand (FTSTS) in seconds

Functional mobility

时间窗: 8 weeks

Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)

Stand and go

时间窗: 8 weeks

Time Up and Go test (TUG) in seconds

Walking speed

时间窗: 8 weeks

The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk

次要结局

  • The Set shifting (Mental flexibility)(8 weeks)
  • Participation agreement(4 months)
  • Feasibility of recruitement(4 months)
  • Costs(8 months)
  • The response inhibition(8 weeks)
  • The updating (Working memory)(8 weeks)
  • Drop out / withdraw(8 months)

研究者

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

Mittaz Hager Anne-Gabrielle

Professor

HES-SO Valais-Wallis

研究点 (2)

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