NCT07050589

Brief Summary

Investigators will develop and deliver a community-based recreation program, delivering group artmaking and group SMARTfit dual-task exergaming to community-dwelling older adults. The program will be delivered through the Buffalo-Niagara YMCA. Outcomes of interest are change in cognitive function and change in physical functioning, inresponse to 24 weeks of weekly training.

Trial Health

77
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
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

April 8, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

April 8, 2025

Last Update Submit

March 13, 2026

Conditions

Keywords

walkingbalancestrengthattentionmemoryinterference inhibitiondual-taskartmakingexergaming

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function: Attention

    Change in performance on the Trail-Making Test

    From enrollment to week 8 and then week 16

Secondary Outcomes (3)

  • Balance

    From enrollment to week 8 and then week 16

  • Dual-Task Performance

    From enrollment to week 8 and then week 16

  • Cognitive Function: Interference Inhibition

    baseline to week 8, through week 16

Study Arms (2)

Program

EXPERIMENTAL

Program participants will receive the recreation-based program.

Behavioral: Exercise and art

Control

NO INTERVENTION

Control participants will receive no recreation-based program.

Interventions

Weekly SMARTfit dual-task exergaming and group art-making

Program

Eligibility Criteria

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

You may qualify if:

  • \> = 60 years of age
  • have no more than MCI (MoCA score ≥ 24 points)
  • have no contraindications to exercise, guided by the American College of Sports Medicine
  • 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 (PAR-OA);
  • 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
  • have experienced a lower or upper limb amputation
  • have greater than mild cognitive impairment (MoCA score \< 24 points).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo-Niagara YMCA

Buffalo, New York, 14223, United States

RECRUITING

MeSH Terms

Interventions

ExerciseReproductive Techniques, Assisted

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaReproductive TechniquesTherapeuticsInvestigative Techniques

Central Study Contacts

Nikhil Satchidanand, PhD Exercise Physiology

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

April 8, 2025

First Posted

July 3, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

July 11, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Requests to access deidentified participant data can be submitted starting 12 months after article publication and the data will be made accessible for up to 12 months. Access to IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, contact NS1@buffalo.edu.

Shared Documents
STUDY PROTOCOL
Time Frame
06/15/2026 - 05/14/2027
Access Criteria
Access to IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations