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临床试验/NCT04237519
NCT04237519已完成不适用

StayFitLonger. Preventive Effects of a Combination of Non-drug Interventions (Physical, Cognitive and Social) in Healthy Elderly Subjects: Multicentre Randomised Controlled Trial.

University of Lausanne Hospitals8 个研究点 分布在 3 个国家目标入组 120 人开始时间: 2019年1月11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
120
试验地点
8
主要终点
Timed-Up & Go Test (TUG)

研究概览

简要总结

Multimodal training, including physical and cognitive activities, has been associated with a reduction in age-related physical and cognitive decline. Therefore, combining these activities into a home-based computerized training program may represent a powerful approach to foster independent life at home. The StayFitLonger study is a 6-month multi-site randomized controlled, double-blind trial, which tests the efficacy of a home-based computerized intervention that combines physical and cognitive exercises through virtual coaching to enhance motivation.

In Switzerland, Canada and Belgium, a total of 128 older participants will be recruited and randomly assigned to one of two physical and cognitive home-based interventions for 6 months: StayFitLonger or active control training. The StayFitLonger intervention provides physical and cognitive training exercises, feedback and instructions through a virtual coach to optimize motivation. It also offers social and psycho-educational contents. Monthly supervision (home-visits and phone calls) will be provided during this 6-month intervention. Outcomes will be measured at baseline, and after 6 months of training.

This study will demonstrate the feasibility, sustainability and efficacy of a home-based multi-domain intervention program allowing further development and possible commercialization of a scientifically validated training program to slow down cognitive and physical decline.

详细描述

Finding ways to improve and maintain functional abilities and quality of life in older people has become a worldwide priority. It is well recognized that reduced engagement in physical, cognitive and social activities has negative influence on the health of older adults. This leads to more vulnerabilities both physically and cognitively. Sedentary behaviors can ultimately induce physical frailty, defined as a state of high vulnerability with accumulation of adverse health outcomes. Fear of falling and/or unsteady gait are common factors of physical frailty. Moreover, falls are particularly common in older adults. In addition to mobility limitation and falls, cognitive decline has been identified as a major cause of disability and dependency in older populations.

Through non-pharmacological interventions focusing on alterable lifestyle factors, experts believe in the possibility to protect older people from the deleterious effects of physical and brain aging that can lead to dementia. In other words, keeping a healthy mind in a healthy body might be the gold standard for healthy aging. Several studies have shown that physical activity, through aerobic, gait and strength training, induces many beneficial effects including improvement of general health, cognition and quality of life. In addition, a growing number of cognitive interventions have been conducted in healthy seniors and older adults with mild cognitive impairment (MCI) and results show improved cognition and delayed cognitive decline. As well, cognitive deficits, mainly in executive functions, have been associated with an increase number of falls and abnormal gait among others.

Improvement of these physical functions was observed in response to cognitive interventions. Because aging is complex and different interventions are likely to potentiate their effects, an increasing number of studies have reported on combined interventions targeting two or more modifiable factors. However, accessibility to these interventions remain a major challenge because older adults may not have access to specialized expertise and resources.

The use of a computerized system to deliver lifestyle interventions have several advantages: it can be used to support home-based training, reducing costs and increasing access; training can be self-paced and last over practically a unlimited time; it allows providing immediate feedback; it offers potential for scaling up for wider use if efficacy is proven; it provides an excellent interface for active control interventions. Surprisingly, whereas many studies assessed computerized cognitive training programs, only a few have used home-based interventions which combine cognitive training with physical activity and, to our knowledge, only one study used computerized tasks for both physical and cognitive training in healthy older adults.

The StayFitLonger study was designed to test efficacy of a home-based computerized training program targeted at older adults, which combine physical exercises and cognitive training. The main goal of the program is to improve physical health and prevent frailty through an innovative approach using videos of 50 physical exercises focusing on gait and strength, which could be easily implemented in older adults (Test-and-Exercise home-based program). The program was also designed to enhance cognitive functions through a series of activities in form of serious games. These activities train executive control through dual-task exercises that was found to increase divided attention and frontal lobe function general knowledge learning and problem solving training. Other features of the program that are unique include: 1) Prospective memory exercises embedded in the physical exercises; 2) Social interactions whereby participants can create and share with other participants their learning material and can chat with their peers about topics of interest and find solutions to common real-life problems; 3) Psycho-educational content on cognition, physical health, nutrition and on ways to apply newly learned strategies in real life to empower participants and promoting self-management; 4) A virtual coach aimed to improve adherence by guiding participants, reminding them to use the program regularly, and providing feedback and rewards through a system of virtual credits; 5) Possibility to personalize the application settings to tailor the environment to the participant's tastes and wishes; 6) Wearable motion sensors used during physical exercises for movement detection as a game input and for providing measurements on mobility for a better characterization of the potential benefits of the program.

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
Double (Participant, Outcomes Assessor)

盲法说明

Assessors are blind to the hypotheses and to participants' assignment as they only have access to the testing sessions. Participants are asked not to mention elements of their training program to assessors . Would such circumstance occur, it will be reported but this should have minimal effect on integrity as the assessors are blind to the hypotheses.

Team members responsible of the statistical analyses are blind to the training assignment as they only have access to anonymized data set and have no access to neither participants' assignment nor the randomization list.

At each study site, study coordinators and trainers responsible for the introductory and refresher courses, and supervision of participants during the home-based training are not blind.

Participants are aware that the trial has two different training conditions that are compared to each other and that they are randomly allocated to one of them. However, they are not informed of the study hypotheses.

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

  • Fluent french speaker adults
  • Retired, living at home and having a wireless Internet connection in their house;
  • Independent for all daily activities (optimal score to the 4-IADL);
  • Open to the use of new technologies and electronic tablets;
  • Interested in exercising to stay fit;
  • Able to walk without a walking aid (e.g. wheelchair, sticks, walker, etc.);
  • Available to commit themselves for the time period during which the study takes place;
  • No vision deficits that would prevent them to read information on a tablet;
  • No current neurological or psychiatric diagnosis (e.g. Parkinson's disease).

排除标准

  • MoCA score < 26;
  • score ≥ 3 on the Fried's frailty index (Fried et al., 2001)

结局指标

主要结局

Timed-Up & Go Test (TUG)

时间窗: T1 (six months following T0)

To measure lower extremity function, mobility and risk of falls

次要结局

  • Physical domain: Twenty-meter walking test(T1 (six months following T0))
  • Physical domain: Five Time Sit to Stand Test (FTSTS)(T1 (six months following T0))
  • Cognitive domain: Global cognition composite score(T1 (six months following T0))
  • Cognitive domain: Executive composite score(T1 (six months following T0))
  • Cognitive domain: Speed processing composite score(T1 (six months following T0))
  • Physical domain: Four Stage Balance Test (FSBT)(T1 (six months following T0))
  • Physical domain: motion sensors measures(T1 (six months following T0))
  • Cognitive domain: Memory composite score(T1 (six months following T0))
  • Affective domain: Hospital Anxiety and Depression Scale (HADS)(T1 (six months following T0))
  • Affective domain: Falls Efficacy Scale International (FES-I)(T1 (six months following T0))
  • Psycho-social domain: Older People Quality of Life questionnaire (OPQOL 35).(T1 (six months following T0))
  • Psycho-social domain: Cognitive Function Instrument (CFI) -(T1 (six months following T0))
  • Psycho-social domain: Everyday Cognition (E-Cog)(T1 (six months following T0))
  • Psycho-social domain: Ad-hoc questionnaire(T1 (six months following T0))
  • Cognitive processes manipulated during training: ad-hoc computerized test(T1 (six months following T0))
  • Cognitive processes manipulated during training: Rivermead Behavioural Memory Test - Third edition (RBMT-3).(T1 (six months following T0))
  • Cognitive processes manipulated during training: Flexibility subtest from the Test battery for Attention Performance(T1 (six months following T0))
  • Cognitive processes manipulated during training: Similitudes subtest from the WAIS-IV:(T1 (six months following T0))

研究者

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

Jean-François Démonet

Professor

University of Lausanne Hospitals

研究点 (8)

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