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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05771064
Other study ID # 2022-1412
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 21, 2023
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source University of Illinois at Chicago
Contact Lijuan Yin, PhD
Phone 312-413-1119
Email lyin4@uic.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date April 30, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Naoko Muramatsu Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Program Feasibility • Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no). 3 months
Primary 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
Primary Feasibility of NIH Toolbox Cognition Battery Feasibility of NIH Toolbox Cognition Battery measured by administration time. 3 months
Secondary NIH Toolbox Cognition Battery scores NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition) 3 months
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