Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)

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.

Study Overview

• Status: Completed
• Conditions: MCI; Mild Dementia
• Intervention / Treatment: Behavioral: Gentle Moves

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Naoko Muramatsu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gentle Moves; Three-month physical activity intervention.	Behavioral: Gentle Moves; 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.
No Intervention: Usual Care; Usual care provided by neuropsychologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Feasibility	• Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).	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)	3 months
Feasibility of NIH Toolbox Cognition Battery	Feasibility of NIH Toolbox Cognition Battery measured by administration time.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Toolbox Cognition Battery scores	NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)	3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2022-1412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No