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

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05771064
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 8.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
MCI; Mild Dementia	Behavioral: Gentle Moves	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
• Anticipated Study Start Date: Mar 13, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Program Feasibility [3 months]

   • Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).

2. Program Acceptability [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)

3. Feasibility of NIH Toolbox Cognition Battery [3 months]

   Feasibility of NIH Toolbox Cognition Battery measured by administration time.

Secondary Outcome Measures

1. NIH Toolbox Cognition Battery scores [3 months]

   NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naoko Muramatsu, Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT05771064
• Other Study ID Numbers: 2022-1412
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Mar 16, 2023