NCT07104435

Brief Summary

This aim of this study is to examine the therapeutic impacts of a group-based recreational program that delivers guided visual artmaking and dual-task exergaming, to older adults. Outcomes of interest include cognitive function (attention, task-switching, interference inhibition), physical function (balance, walking, lower-limb strength), and dual-task performance. Key implementation outcomes including intervention fidelity, feasibility, and acceptability will be explored to inform design of future community-based intervention programs.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

8 months

First QC Date

July 29, 2025

Last Update Submit

October 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in performance on the Stroop Color-Word Test

    Change in score on the Stroop Color-Word Test

    From enrollment to study end at 24 weeks

  • Performance on the Trail Making Test

    Change in score on the Trail Making Test

    From baseline to study end at 24 weeks

Secondary Outcomes (3)

  • Performance on Four Stage Balance Test

    From baseline to study end at 24 weeks

  • Performance on the Six-Minute Walk Test

    From baseline to study end at 24 weeks

  • Dual-Task Ability

    From baseline to study end at 24 weeks

Study Arms (2)

Control

NO INTERVENTION

No artmaking, no exergaming

Artmaking and Exergaming

EXPERIMENTAL

Weekly group-based visual artmaking and dual-task exergaming

Other: Artmaking and exergaming

Interventions

Weekly visual artmaking and exergaming

Artmaking and Exergaming

Eligibility Criteria

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

You may qualify if:

  • Have no more than MCI (Montreal Cognitive Assessment score ≥ 24 points)
  • Have no contraindications to exercise guided by the American College of Sports Medicine (ACSM)
  • Fluent in English

You may not qualify if:

  • Have a condition that would prevent safe participation in the exercise, as determined by the Physical Activity Readiness Questionnaire for Older Adults
  • Have severe neurological disease.
  • Have severe psychiatric illness.
  • Have a likelihood of withdrawing from the study due to severe illness or a life expectancy of \< 6 mo.
  • Having a lower or upper limb amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14223, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

September 12, 2025

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Locations