MCIPhase 1Pro-Home MeCNCT05771064
Promoting In-Home Activities at a Memory & Aging Clinic
A Phase 1 study testing Gentle Moves in people with MCI and Mild Dementia, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- MCI, Mild Dementia
- What is being tested?
- Gentle Moves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 5 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50+
- Fluent in English
- Diagnosed with MCI or mild dementia
- Physically inactive (< 150 min/wk of planned PA)
- Able to sit in a chair independently for 15+ minutes
Who cannot join
- Have significant mental or physical disabilities that lead to inability to perform PA safely (e.g., major stroke)
- Severe uncompensated hearing or visual loss
- Having insufficient decisional capacity to consent to participate in research.
- Lack of safety awareness
- Unwilling to be assigned to Pro-Home MeC or control group
- Currently participating in PA intervention research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.
- Conditions
- MCI, Mild Dementia
- Being tested
- Gentle Moves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle MovesBehavioural
A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position; and two movements in the standing position. The intervention will be delivered by a research coach.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Moves | Experimental | Three-month physical activity intervention. Receives: Behavioral: Gentle Moves |
| Usual Care | No intervention | Usual care provided by neuropsychologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility
- Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).
Measured: 3 months
Program Acceptability
- Program acceptability measured by patient's perception of the program difficulty. (Too hard, a little too hard, just right, a little too easy, much easy)
Measured: 3 months
Feasibility of NIH Toolbox Cognition Battery
Feasibility of NIH Toolbox Cognition Battery measured by administration time.
Measured: 3 months
Secondary outcomes (1)
NIH Toolbox Cognition Battery scores
NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start21 Mar 2023
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Naoko Muramatsu, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771064
- Sponsor's protocol ID
- 2022-1412
- Acronym
- Pro-Home MeC
- Status last verified
- May 2025
- First submitted
- 3 Nov 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
- ClinicalTrials.gov ID
- NCT05771064
- Acronym / sponsor ID
- Pro-Home MeC / 2022-1412
- Conditions
- MCI, Mild Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 16 Mar 2023 (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.
The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentle Moves | Experimental | Behavioral: Gentle MovesThree-month physical activity intervention. |
| Usual Care | No intervention | –Usual care provided by neuropsychologist. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50+
- Fluent in English
- Diagnosed with MCI or mild dementia
- Physically inactive (< 150 min/wk of planned PA)
- Able to sit in a chair independently for 15+ minutes
Key exclusion criteria (6 listed)
- Have significant mental or physical disabilities that lead to inability to perform PA safely (e.g., major stroke)
- Severe uncompensated hearing or visual loss
- Having insufficient decisional capacity to consent to participate in research.
- Lack of safety awareness
- Unwilling to be assigned to Pro-Home MeC or control group
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 |
|---|---|---|
| Gentle MovesA safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position; and two movements in the standing position. The intervention will be delivered by a research coach. | Behavioural | Gentle Moves |
Primary outcome
Program Feasibility
Time frame: 3 months
• Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).
Program Acceptability
Time frame: 3 months
• Program acceptability measured by patient's perception of the program difficulty. (Too hard, a little too hard, just right, a little too easy, much easy)
Feasibility of NIH Toolbox Cognition Battery
Time frame: 3 months
Feasibility of NIH Toolbox Cognition Battery measured by administration time.
1 secondary outcome
NIH Toolbox Cognition Battery scores
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing Gentle Moves in people with MCI and Mild Dementia, run by University of Illinois Chicago 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 5 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: finished, as of the sponsor's last update on 29 May 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Program Feasibility (time frame: 3 months). The study lists 3 primary outcomes in all. 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 29 May 2025.