NCT04237519

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

January 13, 2020

Last Update Submit

August 16, 2023

Conditions

Cognitive Decline Prevention in Robust Older AdultsCognitive Decline Prevention in Pre-frail Older AdultsPhysical Decline Prevention in Robust Older AdultsPhysical Decline Prevention in Pre-frail Older Adults

Keywords

Multimodal interventionCognitive trainingPhysical trainingSocial interactionsPreventionFrailty

Outcome Measures

Primary Outcomes (2)

  • Timed-Up & Go Test (TUG)

    To measure lower extremity function, mobility and risk of falls

    T0 (baseline)

  • Timed-Up & Go Test (TUG)

    To measure lower extremity function, mobility and risk of falls

    T1 (six months following T0)

Secondary Outcomes (36)

  • Physical domain: Twenty-meter walking test

    T0 (baseline)

  • Physical domain: Twenty-meter walking test

    T1 (six months following T0)

  • Physical domain: Five Time Sit to Stand Test (FTSTS)

    T0 (baseline)

  • Physical domain: Five Time Sit to Stand Test (FTSTS)

    T1 (six months following T0)

  • Physical domain: Four Stage Balance Test (FSBT)

    T0 (baseline)

  • +31 more secondary outcomes

Other Outcomes (3)

  • Effects of moderators on primary and secondary outcomes: Age

    Age measured within a month prior to the start of the intervention

  • Effects of moderators on primary and secondary outcomes: Sex

    Sex measured within a month prior to the start of the intervention

  • Effects of moderators on primary and secondary outcomes: Education

    Education measured within a month prior to the start of the intervention

Study Arms (2)

SFL training

EXPERIMENTAL

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

Active control training

ACTIVE COMPARATOR

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

Interventions

SFL trainingBEHAVIORAL

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.

SFL training
Active controlled trainingBEHAVIORAL

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.

Active control training

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BRUSANO (ASBL - Association Sans But Lucratif)

Brussels, 1000, Belgium

Location

Centre Public d'Action Sociale

Woluwe-Saint-Lambert, 1200, Belgium

Location

Institut universitaire de gériatrie de Montréal - CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, H3W 1W5, Canada

Location

Centre Leenaards de la mémoire - Centre hospitalier universitaire Vaudois

Lausanne, Canton of Vaud, CH - 1011, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 11253156BACKGROUND

  • Belleville S, Cuesta M, Bieler-Aeschlimann M, Giacomino K, Widmer A, Mittaz Hager AG, Perez-Marcos D, Cardin S, Boller B, Bier N, Aubertin-Leheudre M, Bherer L, Berryman N, Agrigoroaei S, Demonet JF. Pre-frail older adults show improved cognition with StayFitLonger computerized home-based training: a randomized controlled trial. Geroscience. 2023 Apr;45(2):811-822. doi: 10.1007/s11357-022-00674-5. Epub 2022 Oct 21.

    PMID: 36266559DERIVED

  • Belleville S, Cuesta M, Bieler-Aeschlimann M, Giacomino K, Widmer A, Mittaz Hager AG, Perez-Marcos D, Cardin S, Boller B, Bier N, Aubertin-Leheudre M, Bherer L, Berryman N, Agrigoroaei S, Demonet JF. Rationale and protocol of the StayFitLonger study: a multicentre trial to measure efficacy and adherence of a home-based computerised multidomain intervention in healthy older adults. BMC Geriatr. 2020 Aug 28;20(1):315. doi: 10.1186/s12877-020-01709-2.

    PMID: 32859156DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 23, 2020

Study Start

January 11, 2019

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)BE(2)CA(1)