The StayFitLonger Study: an Innovative Computerized Home-based Training to Foster Independent Life at Home
Condition: Cognitive Decline Prevention in Robust Older Adults; Cognitive Decline Prevention in Pre-frail Older Adults; Physical Decline Prevention in Robust Older Adults; Physical Decline Prevention in Pre-frail Older Adults
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The StayFitLonger study will test the effect of the training on key outcomes using a
      double-blind, parallel-group, randomised control trial (RCT) over 6 months. The primary
      objective is to assess whether the 6-month StayFitLonger programme leads to better
      performance than those observed following the active control condition on the Timed-Up & Go
      (TUG), a functional physical task, which is associated with lower-body strength and balance.
      The efficacy study also includes a few secondary objectives. One is to assess whether the
      StayFitLonger programme improves other physical capabilities as well as cognitive
      performances and scores of affective variables (e.g., mood, fear of falling), and
      psycho-social domains (e.g., quality of life, daily living activities, participant's
      expectation). In addition, the study will also assess whether a similar gain is found in
      robust vs pre-frail seniors.

      In Switzerland, Canada and Belgium, a total of 128 older participants will be recruited.
      Following the initial eligibility screening, participants will be randomized to one of two
      home-based computerized intervention conditions, the StayFitLonger training program
      (experimental) or the active control training program . Enrolled participants will be
      evaluated at two time points: at baseline (T0) and after 6 months of training (T1, end of the
      RCT). The training will take place at home for 6 months. Prior to the start of the training
      and within a month following T0 assessment, introductory courses in groups of a maximum of 6
      people will take place to introduce the features of the program and describe the different
      physical and cognitive exercises. Participants will be supervised through home visits and
      monthly phone calls to ensure a good use of the program in both groups.
    

Intervention name(s): SFL training; Active controlled training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The SFL training program comprises:
Physical exercises: 50 video exercises to improve balance, muscle strength and physical capabilities in older adults;
Cognitive exercises: Four ludic activities targeting problem solving (4 Images/ 1 word), memory (Quiz and Recall me), speed processing and divided attention (Attention!).
In addition, the SFL program includes a series of unique components:
Chat rooms: to share views about topics of interest and tips for common real-life problems;
Psycho-education content: to improve self-management and promoting cognitive transfer though 22 different topics (provide recommendations usually given in psychotherapy sessions);
Virtual coach: to guide participants along the proposed exercises by giving them instructions, reminding them regularly to practice a variety of available activities repeatedly, providing appropriate and timely feedback on participant's performances and rewarding assiduity, perseverance and performance.; The active control training program is structured in the same manner as the SFL training program and will also offer different physical and cognitive activities:
Physical exercises: 12 different exercises trains upper and lower extremity strength, mobility and balance offered through a computerized version of a health insurance company physical training program;
Cognitive activities: Four commercially available leisure activities (Sudoku. Cross Words, Pac-Man and Countdown activities) that are appreciated by older adults but do not teach cognitive strategies and are were not designed to improve cognition per se.
No chat room, psycho-educational content or virtual coach were included in the active control training program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, parallel-group (intervention A vs B), multicentric randomized control trial (RCT). A stratification will separate robust from pre-frail healthy older adults in each intervention.
Note that the study is combined with a further 6-month observational study to test adherence, user experience and acceptability in all participants.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Multimodal intervention; Cognitive training; Physical training; Social interactions; Prevention; Frailty