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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237519
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
HES-SO Valais-Wallis
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Haute-Ecole Arc
Mindmaze SA
Université Catholique de Louvain
Active and Assisted Living Programme
BRUSANO
Pro-Senectute Vaud
Information provided by (Responsible Party):
Jean-François Démonet, University of Lausanne Hospitals

Brief 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.


Condition or disease Intervention/treatment Phase
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 Behavioral: SFL training Behavioral: Active controlled training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
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)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: StayFitLonger. Preventive Effects of a Combination of Non-drug Interventions (Physical, Cognitive and Social) in Healthy Elderly Subjects: Multicentre Randomised Controlled Trial.
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: SFL training

Practice recommendation 3 times per week:

  • Physical exercises: between 30 to 45 minutes that can be split during the day (e.g. 2x15 or 20 minutes, or 3x10 or 15 minutes during the same day).
  • Cognitive exercises: minimum of 15 min.
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 Comparator: Active control training

Practice recommendation 3 times per week:

  • Physical exercises: between 30 to 45 minutes that can be split during the day (e.g. 2x15 or 20 minutes, or 3x10 or 15 minutes during the same day).
  • Cognitive exercises: minimum of 15 min.
Behavioral: 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.





Primary Outcome Measures :
  1. Timed-Up & Go Test (TUG) [ Time Frame: T0 (baseline) ]
    To measure lower extremity function, mobility and risk of falls

  2. Timed-Up & Go Test (TUG) [ Time Frame: T1 (six months following T0) ]
    To measure lower extremity function, mobility and risk of falls


Secondary Outcome Measures :
  1. Physical domain: Twenty-meter walking test [ Time Frame: T0 (baseline) ]
    To measure gait speed in sec.

  2. Physical domain: Twenty-meter walking test [ Time Frame: T1 (six months following T0) ]
    To measure gait speed in sec.

  3. Physical domain: Five Time Sit to Stand Test (FTSTS) [ Time Frame: T0 (baseline) ]
    To measure lower extremity strength in sec

  4. Physical domain: Five Time Sit to Stand Test (FTSTS) [ Time Frame: T1 (six months following T0) ]
    To measure lower extremity strength in sec

  5. Physical domain: Four Stage Balance Test (FSBT) [ Time Frame: T0 (baseline) ]
    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.

  6. Physical domain: Four Stage Balance Test (FSBT) [ Time Frame: T1 (six months following T0) ]
    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.

  7. Physical domain: motion sensors measures [ Time Frame: T0 (baseline) ]
    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.

  8. Physical domain: motion sensors measures [ Time Frame: T1 (six months following T0) ]
    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.

  9. Cognitive domain: Global cognition composite score [ Time Frame: T0 (baseline) ]

    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.

  10. Cognitive domain: Global cognition composite score [ Time Frame: T1 (six months following T0) ]

    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.

  11. Cognitive domain: Memory composite score [ Time Frame: T0 (baseline) ]

    This score is computed by averaging z-scores from:

    • Delayed recall of the CVLT;
    • Delayed recall of the WMS-IV Logical Memory Test.

  12. Cognitive domain: Memory composite score [ Time Frame: T1 (six months following T0) ]

    This score is computed by averaging z-scores from:

    • Delayed recall of the CVLT;
    • Delayed recall of the WMS-IV Logical Memory Test.

  13. Cognitive domain: Executive composite score [ Time Frame: T0 (baseline) ]

    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)).

  14. Cognitive domain: Executive composite score [ Time Frame: T1 (six months following T0) ]

    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)).

  15. Cognitive domain: Speed processing composite score [ Time Frame: T0 (baseline) ]

    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).

  16. Cognitive domain: Speed processing composite score [ Time Frame: T1 (six months following T0) ]

    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).

  17. Affective domain: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T0 (baseline) ]
    To measure mood.

  18. Affective domain: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T1 (six months following T0) ]
    To measure mood.

  19. Affective domain: Falls Efficacy Scale International (FES-I) [ Time Frame: T0 (baseline) ]
    To measure fear of falling.

  20. Affective domain: Falls Efficacy Scale International (FES-I) [ Time Frame: T1 (six months following T0) ]
    To measure fear of falling.

  21. Psycho-social domain: Older People Quality of Life questionnaire (OPQOL 35). [ Time Frame: T0 (baseline) ]
    To measure quality of Life (QoL)

  22. Psycho-social domain: Older People Quality of Life questionnaire (OPQOL 35). [ Time Frame: T1 (six months following T0) ]
    To measure quality of Life (QoL)

  23. Psycho-social domain: Cognitive Function Instrument (CFI) - [ Time Frame: T0 (baseline) ]
    To measure subjective difficulties encountered in activities of daily living, related to cognitive functions

  24. Psycho-social domain: Cognitive Function Instrument (CFI) - [ Time Frame: T1 (six months following T0) ]
    To measure subjective difficulties encountered in activities of daily living, related to cognitive functions

  25. Psycho-social domain: Everyday Cognition (E-Cog) [ Time Frame: T0 (baseline) ]
    To measure subjective difficulties encountered in activities of daily living, related to cognitive functions

  26. Psycho-social domain: Everyday Cognition (E-Cog) [ Time Frame: T1 (six months following T0) ]
    To measure subjective difficulties encountered in activities of daily living, related to cognitive functions

  27. Psycho-social domain: Ad-hoc questionnaire [ Time Frame: T0 (baseline) ]
    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.

  28. Psycho-social domain: Ad-hoc questionnaire [ Time Frame: T1 (six months following T0) ]
    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.

  29. Cognitive processes manipulated during training: ad-hoc computerized test [ Time Frame: T0 (baseline) ]
    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.

  30. Cognitive processes manipulated during training: ad-hoc computerized test [ Time Frame: T1 (six months following T0) ]
    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.

  31. Cognitive processes manipulated during training: Rivermead Behavioural Memory Test - Third edition (RBMT-3). [ Time Frame: T0 (baseline) ]
    To measure prospective memory trained in the Quiz activity with two subtests ("belonging" and "appointment")

  32. Cognitive processes manipulated during training: Rivermead Behavioural Memory Test - Third edition (RBMT-3). [ Time Frame: T1 (six months following T0) ]
    To measure prospective memory trained in the Quiz activity with two subtests ("belonging" and "appointment")

  33. Cognitive processes manipulated during training: Flexibility subtest from the Test battery for Attention Performance [ Time Frame: T0 (baseline) ]
    To measure concept elaboration trained in the 4images/1 word activity with a "set shifting" computerized task

  34. Cognitive processes manipulated during training: Flexibility subtest from the Test battery for Attention Performance [ Time Frame: T1 (six months following T0) ]
    To measure concept elaboration trained in the 4images/1 word activity with a "set shifting" computerized task

  35. Cognitive processes manipulated during training: Similitudes subtest from the WAIS-IV: [ Time Frame: T0 (baseline) ]
    To measure concept elaboration trained in the 4images/1 word activity and assess verbal reasoning and the development of concepts.

  36. Cognitive processes manipulated during training: Similitudes subtest from the WAIS-IV: [ Time Frame: T1 (six months following T0) ]
    To measure concept elaboration trained in the 4images/1 word activity and assess verbal reasoning and the development of concepts.


Other Outcome Measures:
  1. Effects of moderators on primary and secondary outcomes: Age [ Time Frame: Age measured within a month prior to the start of the intervention ]
    To see the influence of age on primary and secondary outcomes using 2 age groups defined by the median

  2. Effects of moderators on primary and secondary outcomes: Sex [ Time Frame: Sex measured within a month prior to the start of the intervention ]
    To see the influence of sex on primary and secondary outcomes using 2 sex groups (male and female)

  3. Effects of moderators on primary and secondary outcomes: Education [ Time Frame: Education measured within a month prior to the start of the intervention ]
    To see the influence of education on primary and secondary outcomes using 2 education groups (less or more than 12 years)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237519


Contacts
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Contact: Antoine Widmer, PhD +41 27 606 90 78 Antoine.Widmer@hevs.ch

Locations
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Belgium
BRUSANO (ASBL - Association Sans But Lucratif) Recruiting
Bruxelles, Belgium, 1000
Contact: Pia Vandebergh       Pia.VANDEBERGH@brusano.brussels   
Principal Investigator: Stefan Agrigoroaei, PhD         
Centre Public d'Action Sociale Recruiting
Woluwe-Saint-Lambert, Belgium, 1200
Contact: Pia Vanderbergh       Pia.VANDEBERGH@brusano.brussels   
Principal Investigator: Stefan Agrigoroaei, PhD         
Canada, Quebec
Institut universitaire de gériatrie de Montréal - CIUSSS du Centre-Sud-de-l'Île-de-Montréal Active, not recruiting
Montréal, Quebec, Canada, H3W 1W5
Switzerland
Centre Leenaards de la mémoire - Centre hospitalier universitaire Vaudois Active, not recruiting
Lausanne, Vaud, Switzerland, CH - 1011
Sponsors and Collaborators
University of Lausanne Hospitals
HES-SO Valais-Wallis
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Haute-Ecole Arc
Mindmaze SA
Université Catholique de Louvain
Active and Assisted Living Programme
BRUSANO
Pro-Senectute Vaud
Investigators
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Principal Investigator: Jean-François Demonet, MD, PhD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Sylvie Belleville, PhD Institut universitaire de gériatrie de Montréal - CIUSSS
Principal Investigator: Stefan Agrigoroaei, PhD Université Catholique de Louvain

Publications:
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Responsible Party: Jean-François Démonet, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT04237519    
Other Study ID Numbers: aal‐call‐2017‐068
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-François Démonet, University of Lausanne Hospitals:
Multimodal intervention
Cognitive training
Physical training
Social interactions
Prevention
Frailty
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders