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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05771064
Recruitment Status : Recruiting
First Posted : March 16, 2023
Last Update Posted : May 6, 2024
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Naoko Muramatsu, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE November 3, 2022
First Posted Date  ICMJE March 16, 2023
Last Update Posted Date May 6, 2024
Actual Study Start Date  ICMJE March 21, 2023
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2023)
  • 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).
  • 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)
  • Feasibility of NIH Toolbox Cognition Battery [ Time Frame: 3 months ]
    Feasibility of NIH Toolbox Cognition Battery measured by administration time.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2023)		 NIH Toolbox Cognition Battery scores [ Time Frame: 3 months ]
NIH Toolbox Cognition Battery Fluid Cognition scores (range 59 - 140, higher score means better cognition)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting In-Home Activities at a Memory & Aging Clinic
Official Title  ICMJE Promoting In-Home Activities at a Memory & Aging Clinic (Pro-Home MeC)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • MCI
  • Mild Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Gentle Moves
    Three-month physical activity intervention.
    Intervention: Behavioral: Gentle Moves
  • No Intervention: Usual Care
    Usual care provided by neuropsychologist.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2024)		 28
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2023)		 44
Estimated Study Completion Date  ICMJE April 30, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lijuan Yin, PhD 312-413-1119 lyin4@uic.edu
Contact: Naoko Muramatsu, PhD 312-413-0485 naoko@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05771064
Other Study ID Numbers  ICMJE 2022-1412
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Naoko Muramatsu, University of Illinois at Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Chicago
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP