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临床试验/NCT05862935
NCT05862935已完成不适用

Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease

European University Miguel de Cervantes2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Short Physical Performance Battery

研究概览

简要总结

The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:

  1. Is a basic strength training enough to improve physical function in AD patients?
  2. Is an exercise intervention able to delayed the progression of the disease?
  3. Is an AMRAP intervention feasible in AD patients?

Participants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The persons analyzing the data collected (investigators, statician) will not know to which group each person belongs.

入排标准

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

入选标准

  • MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)
  • Age ≥60 years old
  • Be able to walk with or without aids
  • Be able to follow verbal instructions

排除标准

  • Surgery in the last 3 months
  • Exhibit clear signs of disorientation
  • Clinically confirmed signs of aggressiveness

结局指标

主要结局

Short Physical Performance Battery

时间窗: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining

Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")

次要结局

  • Handgrip strength(0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining)
  • Body mass index(0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining)
  • Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.(Every session (during 13 sessions))

研究者

发起方
European University Miguel de Cervantes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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