Back to resultsPromoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
Primary Purpose
MCI, Mild Dementia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gentle Moves
Sponsored by
About this trial
This is an interventional prevention trial for MCI
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Naoko MuramatsuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gentle Moves
Usual Care
Arm Description
Three-month physical activity intervention.
Usual care provided by neuropsychologist.
Outcomes
Primary Outcome Measures
Program Feasibility
• Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).
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)
Feasibility of NIH Toolbox Cognition Battery
Feasibility of NIH Toolbox Cognition Battery measured by administration time.
Secondary Outcome Measures
NIH Toolbox Cognition Battery scores
NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)
Full Information
NCT ID
NCT05771064
First Posted
November 3, 2022
Last Updated
March 29, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05771064
Brief Title
Promoting In-Home Activities at a Memory & Aging Clinic
Acronym
Pro-Home MeC
Official Title
Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MCI, Mild Dementia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gentle Moves
Arm Type
Experimental
Arm Description
Three-month physical activity intervention.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care provided by neuropsychologist.
Intervention Type
Behavioral
Intervention Name(s)
Gentle Moves
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program Feasibility
Description
• Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).
Time Frame
3 months
Title
Program Acceptability
Description
• 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)
Time Frame
3 months
Title
Feasibility of NIH Toolbox Cognition Battery
Description
Feasibility of NIH Toolbox Cognition Battery measured by administration time.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NIH Toolbox Cognition Battery scores
Description
NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijuan Yin, PhD
Phone
312-413-1119
Email
lyin4@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naoko Muramatsu, PhD
Phone
312-413-0485
Email
naoko@uic.edu
Facility Information:
Facility Name
Naoko Muramatsu
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Yin, PhD
Phone
312-413-1119
Email
lyin4@uic.edu
First Name & Middle Initial & Last Name & Degree
Naoko Muramatsu, PhD
Phone
3124130485
Email
naoko@uic.edu
12. IPD Sharing Statement
Learn more about this trial
Promoting In-Home Activities at a Memory & Aging Clinic
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