The StayFitLonger Study: an Innovative Computerized Home-based Training to Foster Independent Life at Home

Cognitive Decline Prevention in Pre-frail Older Adults Clinical Trial

— SFL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237519
• Other study ID #: aal-call-2017-068
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2023
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• MoCA score < 26;

• score = 3 on the Fried's frailty index (Fried et al., 2001)

Related Conditions & MeSH terms

• Cognitive Decline Prevention in Pre-frail Older Adults
• Cognitive Decline Prevention in Robust Older Adults
• Cognitive Dysfunction
• Physical Decline Prevention in Pre-frail Older Adults
• Physical Decline Prevention in Robust Older Adults

Intervention

Behavioral:
• SFL training
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.
• Active controlled training
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.

Locations

Country	Name	City	State
Belgium	BRUSANO (ASBL - Association Sans But Lucratif)	Bruxelles
Belgium	Centre Public d'Action Sociale	Woluwe-Saint-Lambert
Canada	Institut universitaire de gériatrie de Montréal - CIUSSS du Centre-Sud-de-l'Île-de-Montréal	Montréal	Quebec
Switzerland	Centre Leenaards de la mémoire - Centre hospitalier universitaire Vaudois	Lausanne	Vaud

Sponsors (9)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Active and Assisted Living Programme, BRUSANO, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Haute-Ecole Arc, HES-SO Valais-Wallis, Mindmaze SA, Pro-Senectute Vaud, Université Catholique de Louvain

Countries where clinical trial is conducted

Belgium,  Canada,  Switzerland, 

References & Publications (1)

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of moderators on primary and secondary outcomes: Age	To see the influence of age on primary and secondary outcomes using 2 age groups defined by the median	Age measured within a month prior to the start of the intervention
Other	Effects of moderators on primary and secondary outcomes: Sex	To see the influence of sex on primary and secondary outcomes using 2 sex groups (male and female)	Sex measured within a month prior to the start of the intervention
Other	Effects of moderators on primary and secondary outcomes: Education	To see the influence of education on primary and secondary outcomes using 2 education groups (less or more than 12 years)	Education measured within a month prior to the start of the intervention
Primary	Timed-Up & Go Test (TUG)	To measure lower extremity function, mobility and risk of falls	T0 (baseline)
Primary	Timed-Up & Go Test (TUG)	To measure lower extremity function, mobility and risk of falls	T1 (six months following T0)
Secondary	Physical domain: Twenty-meter walking test	To measure gait speed in sec.	T0 (baseline)
Secondary	Physical domain: Twenty-meter walking test	To measure gait speed in sec.	T1 (six months following T0)
Secondary	Physical domain: Five Time Sit to Stand Test (FTSTS)	To measure lower extremity strength in sec	T0 (baseline)
Secondary	Physical domain: Five Time Sit to Stand Test (FTSTS)	To measure lower extremity strength in sec	T1 (six months following T0)
Secondary	Physical domain: Four Stage Balance Test (FSBT)	To measure balance. A total score of 4 is obtained when a participant performs successfully 4 positions (parallel, semi-tandem and tandem). The test is stopped when a participant fails at holding a given position for at least 10 sec.	T0 (baseline)
Secondary	Physical domain: Four Stage Balance Test (FSBT)	To measure balance. A total score of 4 is obtained when a participant performs successfully 4 positions (parallel, semi-tandem and tandem). The test is stopped when a participant fails at holding a given position for at least 10 sec.	T1 (six months following T0)
Secondary	Physical domain: motion sensors measures	During TUG and 20-m walking test, motion sensors will provide measures on: walking speed, variability in gait, stance phase, foot-flat phase, double support, stride velocity, maximal swing speed, turning angle and variability in toe clearance.	T0 (baseline)
Secondary	Physical domain: motion sensors measures	During TUG and 20-m walking test, motion sensors will provide measures on: walking speed, variability in gait, stance phase, foot-flat phase, double support, stride velocity, maximal swing speed, turning angle and variability in toe clearance.	T1 (six months following T0)
Secondary	Cognitive domain: Global cognition composite score	This score is the ZAVEN composite score computed by averaging z-scores from: Total recall of the California Verbal Learning Test (CVLT) and delayed recall of the WMS-IV Logical Memory to measure episodic memory; WAIS-IV Digit Symbol substitution Test (DSST) to measure complex attention; Verbal fluency (VF) to measure executive functions.	T0 (baseline)
Secondary	Cognitive domain: Global cognition composite score	This score is the ZAVEN composite score computed by averaging z-scores from: Total recall of the California Verbal Learning Test (CVLT) and delayed recall of the WMS-IV Logical Memory to measure episodic memory; WAIS-IV Digit Symbol substitution Test (DSST) to measure complex attention; Verbal fluency (VF) to measure executive functions.	T1 (six months following T0)
Secondary	Cognitive domain: Memory composite score	This score is computed by averaging z-scores from: Delayed recall of the CVLT; Delayed recall of the WMS-IV Logical Memory Test.	T0 (baseline)
Secondary	Cognitive domain: Memory composite score	This score is computed by averaging z-scores from: Delayed recall of the CVLT; Delayed recall of the WMS-IV Logical Memory Test.	T1 (six months following T0)
Secondary	Cognitive domain: Executive composite score	This score is computed by averaging z-scores from: Verbal fluency (VF); Trail Making Test (condition B - A; shifting - processing speed scores); Victoria Stroop (high interference - naming conditions); Divided attention subtest from the Test of Attention Performance 2.3.1 (number of total omissions (visual and auditory)).	T0 (baseline)
Secondary	Cognitive domain: Executive composite score	This score is computed by averaging z-scores from: Verbal fluency (VF); Trail Making Test (condition B - A; shifting - processing speed scores); Victoria Stroop (high interference - naming conditions); Divided attention subtest from the Test of Attention Performance 2.3.1 (number of total omissions (visual and auditory)).	T1 (six months following T0)
Secondary	Cognitive domain: Speed processing composite score	This score is computed by averaging z-scores from: Trail Making Test (time on condition A); DSST (number of correct symbols); Victoria Stroop (time on naming condition).	T0 (baseline)
Secondary	Cognitive domain: Speed processing composite score	This score is computed by averaging z-scores from: Trail Making Test (time on condition A); DSST (number of correct symbols); Victoria Stroop (time on naming condition).	T1 (six months following T0)
Secondary	Affective domain: Hospital Anxiety and Depression Scale (HADS)	To measure mood.	T0 (baseline)
Secondary	Affective domain: Hospital Anxiety and Depression Scale (HADS)	To measure mood.	T1 (six months following T0)
Secondary	Affective domain: Falls Efficacy Scale International (FES-I)	To measure fear of falling.	T0 (baseline)
Secondary	Affective domain: Falls Efficacy Scale International (FES-I)	To measure fear of falling.	T1 (six months following T0)
Secondary	Psycho-social domain: Older People Quality of Life questionnaire (OPQOL 35).	To measure quality of Life (QoL)	T0 (baseline)
Secondary	Psycho-social domain: Older People Quality of Life questionnaire (OPQOL 35).	To measure quality of Life (QoL)	T1 (six months following T0)
Secondary	Psycho-social domain: Cognitive Function Instrument (CFI) -	To measure subjective difficulties encountered in activities of daily living, related to cognitive functions	T0 (baseline)
Secondary	Psycho-social domain: Cognitive Function Instrument (CFI) -	To measure subjective difficulties encountered in activities of daily living, related to cognitive functions	T1 (six months following T0)
Secondary	Psycho-social domain: Everyday Cognition (E-Cog)	To measure subjective difficulties encountered in activities of daily living, related to cognitive functions	T0 (baseline)
Secondary	Psycho-social domain: Everyday Cognition (E-Cog)	To measure subjective difficulties encountered in activities of daily living, related to cognitive functions	T1 (six months following T0)
Secondary	Psycho-social domain: Ad-hoc questionnaire	To measure participant's expectation from the training program. The questionnaire is related to the efficacy of the program and its different components, the expectation (difficulty, agreeableness, motivation) and the quality of the introductory courses.	T0 (baseline)
Secondary	Psycho-social domain: Ad-hoc questionnaire	To measure participant's expectation from the training program. The questionnaire is related to the efficacy of the program and its different components, the expectation (difficulty, agreeableness, motivation) and the quality of the introductory courses.	T1 (six months following T0)
Secondary	Cognitive processes manipulated during training: ad-hoc computerized test	To measure divided attention trained during Attention! activity with an ad-hoc computerized test designed specifically for this multitasking activity and provided in the form of a serious game.	T0 (baseline)
Secondary	Cognitive processes manipulated during training: ad-hoc computerized test	To measure divided attention trained during Attention! activity with an ad-hoc computerized test designed specifically for this multitasking activity and provided in the form of a serious game.	T1 (six months following T0)
Secondary	Cognitive processes manipulated during training: Rivermead Behavioural Memory Test - Third edition (RBMT-3).	To measure prospective memory trained in the Quiz activity with two subtests ("belonging" and "appointment")	T0 (baseline)
Secondary	Cognitive processes manipulated during training: Rivermead Behavioural Memory Test - Third edition (RBMT-3).	To measure prospective memory trained in the Quiz activity with two subtests ("belonging" and "appointment")	T1 (six months following T0)
Secondary	Cognitive processes manipulated during training: Flexibility subtest from the Test battery for Attention Performance	To measure concept elaboration trained in the 4images/1 word activity with a "set shifting" computerized task	T0 (baseline)
Secondary	Cognitive processes manipulated during training: Flexibility subtest from the Test battery for Attention Performance	To measure concept elaboration trained in the 4images/1 word activity with a "set shifting" computerized task	T1 (six months following T0)
Secondary	Cognitive processes manipulated during training: Similitudes subtest from the WAIS-IV:	To measure concept elaboration trained in the 4images/1 word activity and assess verbal reasoning and the development of concepts.	T0 (baseline)
Secondary	Cognitive processes manipulated during training: Similitudes subtest from the WAIS-IV:	To measure concept elaboration trained in the 4images/1 word activity and assess verbal reasoning and the development of concepts.	T1 (six months following T0)