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Interactive Stepping Exercise on Memory

Primary Purpose

Amnestic Mild Cognitive Impairment, Interactive Stepping Exercise, Memory

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interactive stepping exercise
Home exercise
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amnestic Mild Cognitive Impairment focused on measuring square stepping exercise, Amnestic mild cognitive impairment, Interactive stepping exercise, memory, cognitive function, executive function

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age≥50 years
  • Complained of memory impairment
  • Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
  • MMSE score≥24 and CDR score=0.5
  • Activities of daily living are intact
  • DSM-IV criteria for the diagnosis of dementia is not met

Exclusion Criteria:

  • Any significant neurologic disease other than suspected incipient Alzheimer's disease
  • Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Interactive stepping exercise group

    Home exercise group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Chinese version verbal learning test
    Selective reminding test
    Wechsler Memory Scale-III
    Logic memory test

    Secondary Outcome Measures

    Montreal Cognitive Assessment
    Trail making test
    Stroop test
    Executive Interview

    Full Information

    First Posted
    September 20, 2019
    Last Updated
    September 23, 2019
    Sponsor
    National Yang Ming University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04103463
    Brief Title
    Interactive Stepping Exercise on Memory
    Official Title
    Effects of Interactive Stepping Exercise on Memory in Adults With Amnestic Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Yang Ming University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A & B (TMT-A & B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amnestic Mild Cognitive Impairment, Interactive Stepping Exercise, Memory, Cognitive Function, Executive Function
    Keywords
    square stepping exercise, Amnestic mild cognitive impairment, Interactive stepping exercise, memory, cognitive function, executive function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interactive stepping exercise group
    Arm Type
    Experimental
    Arm Title
    Home exercise group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Interactive stepping exercise
    Intervention Description
    An exercise intervention based on the principle of square stepping exercise
    Intervention Type
    Other
    Intervention Name(s)
    Home exercise
    Intervention Description
    Home exercise
    Primary Outcome Measure Information:
    Title
    Chinese version verbal learning test
    Time Frame
    Change from baseline at 12 week
    Title
    Selective reminding test
    Time Frame
    Change from baseline at 12 week
    Title
    Wechsler Memory Scale-III
    Time Frame
    Change from baseline at 12 week
    Title
    Logic memory test
    Time Frame
    Change from baseline at 12 week
    Secondary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment
    Time Frame
    Change from baseline at 12 week
    Title
    Trail making test
    Time Frame
    Change from baseline at 12 week
    Title
    Stroop test
    Time Frame
    Change from baseline at 12 week
    Title
    Executive Interview
    Time Frame
    Change from baseline at 12 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥50 years Complained of memory impairment Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words MMSE score≥24 and CDR score=0.5 Activities of daily living are intact DSM-IV criteria for the diagnosis of dementia is not met Exclusion Criteria: Any significant neurologic disease other than suspected incipient Alzheimer's disease Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yea-Ru Yang
    Phone
    +886228267279
    Email
    yryang@ym.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Interactive Stepping Exercise on Memory

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