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临床试验/NCT05727748
NCT05727748已完成不适用

Effects of a Multimodal Program With Augmented Reality on Cognition, Functional Fitness and Physical Activity in Older Adults

University of Évora2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年5月3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
70
试验地点
2
主要终点
Deary - Liewald reaction time task

研究概览

简要总结

The objectives of the present research is to observe the effects of a multimodal program with augmented reality on cognition, functional fitness, quality of life, and physical activity in older people.

详细描述

The present investigation lasted 16 weeks. The first two weeks were for familiarization with the tests and initial assessments. This was followed by the 12-week intervention and final assessments (2 weeks).

The intervention program ran for 12 weeks with 3 sessions per week of 60 minutes each. There were three different groups: a) a control group; b) a multimodal training group that combined physical training with cognitive training; c) a multimodal training group with augmented reality.

The control group continued their daily activities for 12 weeks and did not participate in any new physical activity program during the study. In the multimodal training group, the session consisted of four stations where participants simultaneously trained physical aspects (cardiorespiratory fitness, strength, balance, and flexibility) and cognitive aspects (reaction time, memory, decision making, semantics, and processing speed). In the multimodal training session with augmented reality, the session consisted of 6 stations, 4 stations as in the previous group and 2 stations with augmented reality. These 2 stations used the same components but through the portable exergame platform for the elderly.

During the 12 weeks, the intensity and difficulty of each exercise was increased after each session, depending on the evolution of the participants.

When forming the training groups, the participants who were not available during the intervention phase were assigned to the control group.

研究设计

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

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both genders
  • 60 years old or more
  • Community-dwelling older adults living independently
  • Able to walk autonomously

排除标准

  • Having cognitive impairment
  • Neurological disorders

结局指标

主要结局

Deary - Liewald reaction time task

时间窗: 13 weeks

Simple and choice reaction time

Mini Mental State Examination (MMSE)

时间窗: 13 weeks

Evaluates the cognitive state of the participant. The MMSE consists of 6 different domains: orientation, retention, attention and calculation; recall; language, and constructive skills. The maximum score for this test is 30 points. However, the education of the participant education is also taken into account when assigning the score.The scores for determining whether a person has cognitive impairment through the Mini-Mental State Examination (MMSE) are: cut-offs of ≤27 points or persons with \>11 years of school education, ≤22 for persons ranging from 1 to 11 years of school education and ≤ 15 points for illiterate persons.

Frontal assessment battery (FAB)

时间窗: 13 weeks

Evaluates executive functions, consisting of 6 tests that explore abilities that are related to the frontal lobes. At FAB, the highest score is 18, indicating the best possible performance on the test. The FAB is divided into 6 domains: Conceptualization, Mental Flexibility, Programming, Sensitivity to Interference, Inhibitory Control, and Environmental Autonomy. In each of the subdomains, the score ranges from 0 (worst performance) to 3 (best performance). The subdomains are assessed by short tasks given to the participants.

Trail Making Test

时间窗: 13 weeks

Cognitive flexibility and processing speed

Stroop

时间窗: 13 weeks

Inhibition and resistance to interference. The stroop test consists of three different tasks, each lasting 45 seconds. In the first task, the participant had to read the words presented, and the words could be red, green, blue, and green. In the second task, participants had to say what color they were seeing (red, green, blue or green). In the last task, participants were presented with several words (red, green, blue, and green) written in different colors and were asked to list the color of ink for each word. The number of correct answers was recorded, with the number of correct answers giving the better score. For the participant to meet the normative data, they should enumerate more than 40 words/colors.

Phonemic and semantic verbal fluency test.

时间窗: 13 weeks

The test assesses language production, non-motor processing speed, and executive functions. In the semantic fluency task, participants had to say as many animals as possible over 60seconds. In the phonemic fluency exercise, participants were asked to list as many words starting with a specific letter as possible. The duration of the exercise was 60seconds. More words correspond to better scores.

次要结局

  • Physical activity(13 weeks)
  • Body Composition(13 weeks)
  • EQ-5D(13 weeks)
  • Senior Fitness Test - Rikli and Jones(13 weeks)
  • SF-36(13 weeks)
  • Geriatric depression scale(13 weeks)

研究者

发起方
University of Évora
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soraia Daniela Pires Ferreira

Principal Investigator

University of Évora

研究点 (2)

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