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

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ClinicalTrials.gov Identifier: NCT05771064
Recruitment Status : Recruiting
First Posted : March 16, 2023
Last Update Posted : April 3, 2024
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Naoko Muramatsu, University of Illinois at Chicago

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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)
Actual Study Start Date : March 21, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Program Feasibility [ Time Frame: 3 months ]
    • Program feasibility measured by program adherence (e.g., self-reported program activities in the past 24 hours, yes/no).

  2. Program Acceptability [ Time Frame: 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 [ Time Frame: 3 months ]
    Feasibility of NIH Toolbox Cognition Battery measured by administration time.


Secondary Outcome Measures :
  1. NIH Toolbox Cognition Battery scores [ Time Frame: 3 months ]
    NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05771064


Contacts
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Contact: Lijuan Yin, PhD 312-413-1119 lyin4@uic.edu
Contact: Naoko Muramatsu, PhD 312-413-0485 naoko@uic.edu

Locations
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United States, Illinois
Naoko Muramatsu Recruiting
Chicago, Illinois, United States, 60608
Contact: Lijuan Yin, PhD    312-413-1119    lyin4@uic.edu   
Contact: Naoko Muramatsu, PhD    3124130485    naoko@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Aging (NIA)
More Information
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Responsible Party: Naoko Muramatsu, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05771064    
Other Study ID Numbers: 2022-1412
First Posted: March 16, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders