- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07050589
- Original Trial
Group Recreation to Enhance Function Aging
March 13, 2026 updated by: Nikhil Satchidanand, State University of New York at Buffalo
A Community-Based Recreation Program to Improve Function and Quality of Life in Older Adults
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nikhil Satchidanand, PhD Exercise Physiology
- Phone Number: 17168162884
- Email: ns1@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14223
- Recruiting
- Buffalo-Niagara YMCA
-
Principal Investigator:
- Nikhil Satchidanand, PhD
-
Contact:
- Jilyana Miklos
- Phone Number: (716)501-5559
- Email: jmiklos@ymcabn.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Program
Program participants will receive the recreation-based program.
|
Weekly SMARTfit dual-task exergaming and group art-making
|
|
No Intervention: Control
Control participants will receive no recreation-based program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function: Attention
Time Frame: From enrollment to week 8 and then week 16
|
Change in performance on the Trail-Making Test
|
From enrollment to week 8 and then week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: From enrollment to week 8 and then week 16
|
Change in balance assessed by the Four Stage Balance Test
|
From enrollment to week 8 and then week 16
|
|
Dual-Task Performance
Time Frame: From enrollment to week 8 and then week 16
|
Dual task performance assessed using the Timed Up and Go-Dual Task
|
From enrollment to week 8 and then week 16
|
|
Cognitive Function: Interference Inhibition
Time Frame: baseline to week 8, through week 16
|
Change in performance on the Stroop Test
|
baseline to week 8, through week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2025
Primary Completion (Estimated)
July 11, 2026
Study Completion (Estimated)
July 15, 2026
Study Registration Dates
First Submitted
April 8, 2025
First Submitted That Met QC Criteria
June 25, 2025
First Posted (Actual)
July 3, 2025
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00008757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan 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.
IPD Sharing Time Frame
06/15/2026 - 05/14/2027
IPD Sharing 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).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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