Group Recreation to Enhance Function Aging | NCT07050589

Studies
Group Recreation to Enhance Function Aging

NCT07050589

Sponsor

State University of New York at Buffalo

Status

Recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Physical Functioning
Cognitive Functioning

Interventions

Exercise and art

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Actual

Primary Completion Date

Jul 11, 2026Estimated

Completion Date

Jul 15, 2026Estimated

First Submitted Date

Apr 8, 2025

First Submission Date that Met QC Criteria

Jun 25, 2025

First Posted Date

Jul 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikhil Satchidanand, Assistant Professor of Internal Medicine, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exercise and art	Behavioral	Weekly SMARTfit dual-task exergaming and group art-making	Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive Function: Attention	Change in performance on the Trail-Making Test	From enrollment to week 8 and then week 16

Secondary Outcomes

Measure	Description	Time Frame
Balance	Change in balance assessed by the Four Stage Balance Test	From enrollment to week 8 and then week 16
Dual-Task Performance	Dual task performance assessed using the Timed Up and Go-Dual Task

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

> = 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

Exclusion Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nikhil Satchidanand, PhD Exercise Physiology	Contact	17168162884		ns1@buffalo.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Buffalo-Niagara YMCA	Recruiting	Buffalo	New York	14223	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

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).

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D027724	Reproductive Techniques, Assisted

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided