NCT05771064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2.1 years

First QC Date

November 3, 2022

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • NIH Toolbox Cognition Battery scores

    3 months

Study Arms (2)

Gentle Moves

EXPERIMENTAL

Three-month physical activity intervention.

Behavioral: Gentle Moves

Usual Care

NO INTERVENTION

Usual care provided by neuropsychologist.

Interventions

Gentle MovesBEHAVIORAL

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.

Gentle Moves

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naoko Muramatsu

Chicago, Illinois, 60608, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

March 16, 2023

Study Start

March 21, 2023

Primary Completion

May 5, 2025

Study Completion

May 5, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations