Physical FunctioningNCT07050589
Group Recreation to Enhance Function Aging
A study testing Exercise and art in people with Physical Functioning and Cognitive Functioning, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Functioning, Cognitive Functioning
- What is being tested?
- Exercise and art
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > = 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Functioning, Cognitive Functioning
- Being tested
- Exercise and art
- Keywords
- walking, balance, strength, attention, memory, interference inhibition, dual-task, artmaking, exergaming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and artBehavioural
Weekly SMARTfit dual-task exergaming and group art-making
| Study group | Role | What they receive |
|---|---|---|
| Program | Experimental | Program participants will receive the recreation-based program. Receives: Behavioral: Exercise and art |
| Control | No intervention | Control participants will receive no recreation-based program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function: Attention
Change in performance on the Trail-Making Test
Measured: From enrollment to week 8 and then week 16
Secondary outcomes (3)
Balance
Change in balance assessed by the Four Stage Balance Test
Measured: From enrollment to week 8 and then week 16
Dual-Task Performance
Dual task performance assessed using the Timed Up and Go-Dual Task
Measured: From enrollment to week 8 and then week 16
Cognitive Function: Interference Inhibition
Change in performance on the Stroop Test
Measured: baseline to week 8, through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Oct 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikhil Satchidanand, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050589
- Sponsor's protocol ID
- 00008757
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Recreation Program to Improve Function and Quality of Life in Older Adults
- ClinicalTrials.gov ID
- NCT07050589
- Acronym / sponsor ID
- 00008757
- Conditions
- Physical Functioning, Cognitive Functioning
- Keywords
- walking, balance, strength, attention, memory, interference inhibition, dual-task, artmaking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program | Experimental | Behavioral: Exercise and artProgram participants will receive the recreation-based program. |
| Control | No intervention | –Control participants will receive no recreation-based program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > = 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and artWeekly SMARTfit dual-task exergaming and group art-making | Behavioural | Program |
Primary outcome
Cognitive Function: Attention
Time frame: From enrollment to week 8 and then week 16
Change in performance on the Trail-Making Test
3 secondary outcomes
Balance
Time frame: From enrollment to week 8 and then week 16
Dual-Task Performance
Time frame: From enrollment to week 8 and then week 16
Cognitive Function: Interference Inhibition
Time frame: baseline to week 8, through week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and art in people with Physical Functioning and Cognitive Functioning, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function: Attention (time frame: From enrollment to week 8 and then week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.