NCT06628999

Brief Summary

Physical activity for healthy ageing is an important feature and the possibility to detect practical solutions to solve the need for feasible health promotion interventions to reduce health disparities and wellbeing in individuals with intellectual disability (ID) is an open question. In this perspective, vision has a remarkable role in spatial cognition and organization, especially in individuals with ID. Therefore, the aim is to investigate the effectiveness of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID throughout 16 weeks. Participants with mild ID will be randomly divided into a perceptual-vision training group, a perceptual-vision training-detraining group and a control group. Cognitive performance and physical fitness will be assessed at baseline, mid and at the end of 16 weeks. In conclusion, a visual training program may present the potentiality to impact various health domains, from cognition to physical performance in individuals with intellectual disabilities, promoting their healthy aging.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 3, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

Visual trainingIntellectual disabilityPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline cognitive performance at 16 week

    Response time on a computerized test conceptualized as a measure of cognitive performance inhibitory control (Modified Flanker Task test). Participants are tasked with identifying the direction of the central target stimulus that is flanked by either congruent (\<\<\<\<\<) or incongruent (\>\>\<\>\>) stimuli by pressing the correct keyboard key.

    Up to sixteen weeks

Secondary Outcomes (4)

  • Change from baseline static balance at 16 week

    Up to sixteen weeks

  • Change from baseline strength at 16 week

    Up to sixteen weeks

  • Change from baseline strength at 16 week

    Up to sixteen weeks

  • Change from baseline movement agility at 16 week

    Up to sixteen weeks

Study Arms (3)

Visual Training Group

EXPERIMENTAL

Visual Training Group: physical training exercises aiming to combine visual skills with basic motor actions for 16 consecutive weeks

Other: Visual Training

Control Group

ACTIVE COMPARATOR

Control Group: active lifestyle based on healthy habits for 16 consecutive weeks

Other: Control Group

Visual Training-detraining Group

EXPERIMENTAL

Visual Training-detraining Group: physical exercises physical training exercises aiming to combine visual skills with basic motor actions for 8 consecutive weeks. The last remaining 8 weeks (up to 16 week) the group will conduct a period of detraining in which no physical exercises will be administered

Other: Visual Training-detraining

Interventions

16-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness

Visual Training Group

16-week of active lifestyle based on healthy habits

Control Group

8-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness, followed by 8 week with no specific training protocol

Visual Training-detraining Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 40 and 70 years
  • mild ID (Intellectual Quotient = 51-69).

You may not qualify if:

  • inability to understand basic verbal communication
  • strict dependence on personnel or assistive support devices
  • presence of concomitant sensorial or physical impairments
  • presence of behavioural problems or any other clinical condition that may compromise the regular physical activity practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Carmeli E, Imam B. Health promotion and disease prevention strategies in older adults with intellectual and developmental disabilities. Front Public Health. 2014 Apr 14;2:31. doi: 10.3389/fpubh.2014.00031. eCollection 2014.

    PMID: 24783190BACKGROUND
  • Erickson KI, Hillman C, Stillman CM, Ballard RM, Bloodgood B, Conroy DE, Macko R, Marquez DX, Petruzzello SJ, Powell KE; FOR 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity, Cognition, and Brain Outcomes: A Review of the 2018 Physical Activity Guidelines. Med Sci Sports Exerc. 2019 Jun;51(6):1242-1251. doi: 10.1249/MSS.0000000000001936.

    PMID: 31095081BACKGROUND
  • Formenti D, Duca M, Trecroci A, Ansaldi L, Bonfanti L, Alberti G, Iodice P. Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females. Sci Rep. 2019 Dec 10;9(1):18671. doi: 10.1038/s41598-019-55252-1.

    PMID: 31822740BACKGROUND
  • Forte R, Trentin C, Tocci N, Lucia S, Aydin M, Di Russo F. Motor-cognitive exercise with variability of practice and feedback improves functional ability and cognition in older individuals. Aging Clin Exp Res. 2023 Nov;35(11):2797-2806. doi: 10.1007/s40520-023-02568-8. Epub 2023 Oct 19.

    PMID: 37853304BACKGROUND
  • Giuliani F, Favrod J, Grasset F, Schenk F. Accurate memory for object location by individuals with intellectual disability: absolute spatial tagging instead of configural processing? Res Dev Disabil. 2011 May-Jun;32(3):986-94. doi: 10.1016/j.ridd.2011.01.055. Epub 2011 Feb 24.

    PMID: 21353464BACKGROUND
  • Henderson JM. Human gaze control during real-world scene perception. Trends Cogn Sci. 2003 Nov;7(11):498-504. doi: 10.1016/j.tics.2003.09.006.

    PMID: 14585447BACKGROUND
  • Horner-Johnson W, Bailey D. Assessing Understanding and Obtaining Consent from Adults with Intellectual Disabilities for a Health Promotion Study. J Policy Pract Intellect Disabil. 2013 Sep;10(3):10.1111/jppi.12048. doi: 10.1111/jppi.12048.

    PMID: 24223054BACKGROUND
  • Krahn GL, Fox MH. Health disparities of adults with intellectual disabilities: what do we know? What do we do? J Appl Res Intellect Disabil. 2014 Sep;27(5):431-46. doi: 10.1111/jar.12067. Epub 2013 Jul 31.

    PMID: 23913632BACKGROUND
  • Santos FH, Zurek J, Janicki MP. Efficacy of Healthy Aging Interventions for Adults With Intellectual and Developmental Disabilities: A Systematic Review. Gerontologist. 2022 Apr 20;62(4):e235-e252. doi: 10.1093/geront/gnaa192.

    PMID: 33220058BACKGROUND
  • Wollesen B, Wildbredt A, van Schooten KS, Lim ML, Delbaere K. The effects of cognitive-motor training interventions on executive functions in older people: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Jul 2;17:9. doi: 10.1186/s11556-020-00240-y. eCollection 2020.

    PMID: 32636957BACKGROUND
  • Cavaggioni L, Formenti D, Castiglioni P, Ardigo LP, Merati G. Perceptual-vision training as a strategy for healthy aging in adults with intellectual disability: a study protocol. Front Psychol. 2025 Apr 24;16:1526826. doi: 10.3389/fpsyg.2025.1526826. eCollection 2025.

MeSH Terms

Conditions

Intellectual DisabilityMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Luca Cavaggioni, PhD

    Universitià degli Studi dell'Insubria

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

May 5, 2025

Primary Completion

October 28, 2025

Study Completion

December 31, 2025

Last Updated

May 6, 2026

Record last verified: 2024-10