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Multicomponent Exercise in People With Dementia

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multicomponent exercise
Video home exercise group
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 60-80 y/o
  • Mini-Mental State Examination: 10-26
  • Clinical Dementia Rating: 1-2
  • Walk at least 6 meters independently (with or without walking aids)

Exclusion Criteria:

  • Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
  • Physical or psychological comorbidities that affect performance during assessment or intervention
  • Already participating in other physical training in the last 1 month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multicomponent exercise group

    Video home exercise group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mini-Mental State Examination
    It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.
    Chinese version of Verbal learning test
    It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.
    Chinese version of Stroop color and word test
    It is a measurement to evaluate inhibition control.
    Digit span test
    It is a measurement to evaluate working memory.
    Trail making test - Chinese version
    It is a measurement to evaluate cognitive flexibility.

    Secondary Outcome Measures

    Barthel index
    It is a 100-point ordinal scale used to measure performance in activities of daily living. Higher scores mean a better outcome.
    Instrumental activities of daily living (IADL) scale
    It is a 24-point ordinal scale used to measure performance in instrumental activities of daily living. Higher scores mean a better outcome.
    Chinese version of Quality of Life in Alzheimer Disease Scale
    It is a measurement to evaluate quality of life. The scale scores range from 13 to 52, with higher scores indicating greater quality of life.
    Time up and go test
    It is a test to evaluate functional mobility.
    30-second chair stand test
    It is a test to evaluate muscle strength.
    6-minute walk test
    It is a test to evaluate endurance.
    Berg Balance Scale
    It is a tool to evaluate balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

    Full Information

    First Posted
    June 18, 2021
    Last Updated
    August 21, 2021
    Sponsor
    National Yang Ming University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04951258
    Brief Title
    Multicomponent Exercise in People With Dementia
    Official Title
    Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Multicomponent exercise group
    Arm Type
    Experimental
    Arm Title
    Video home exercise group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Multicomponent exercise
    Intervention Description
    The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching
    Intervention Type
    Other
    Intervention Name(s)
    Video home exercise group
    Intervention Description
    The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise
    Primary Outcome Measure Information:
    Title
    Mini-Mental State Examination
    Description
    It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.
    Time Frame
    Change from baseline at 9 week
    Title
    Chinese version of Verbal learning test
    Description
    It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.
    Time Frame
    Change from baseline at 9 week
    Title
    Chinese version of Stroop color and word test
    Description
    It is a measurement to evaluate inhibition control.
    Time Frame
    Change from baseline at 9 week
    Title
    Digit span test
    Description
    It is a measurement to evaluate working memory.
    Time Frame
    Change from baseline at 9 week
    Title
    Trail making test - Chinese version
    Description
    It is a measurement to evaluate cognitive flexibility.
    Time Frame
    Change from baseline at 9 week
    Secondary Outcome Measure Information:
    Title
    Barthel index
    Description
    It is a 100-point ordinal scale used to measure performance in activities of daily living. Higher scores mean a better outcome.
    Time Frame
    Change from baseline at 9 week
    Title
    Instrumental activities of daily living (IADL) scale
    Description
    It is a 24-point ordinal scale used to measure performance in instrumental activities of daily living. Higher scores mean a better outcome.
    Time Frame
    Change from baseline at 9 week
    Title
    Chinese version of Quality of Life in Alzheimer Disease Scale
    Description
    It is a measurement to evaluate quality of life. The scale scores range from 13 to 52, with higher scores indicating greater quality of life.
    Time Frame
    Change from baseline at 9 week
    Title
    Time up and go test
    Description
    It is a test to evaluate functional mobility.
    Time Frame
    Change from baseline at 9 week
    Title
    30-second chair stand test
    Description
    It is a test to evaluate muscle strength.
    Time Frame
    Change from baseline at 9 week
    Title
    6-minute walk test
    Description
    It is a test to evaluate endurance.
    Time Frame
    Change from baseline at 9 week
    Title
    Berg Balance Scale
    Description
    It is a tool to evaluate balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
    Time Frame
    Change from baseline at 9 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 60-80 y/o Mini-Mental State Examination: 10-26 Clinical Dementia Rating: 1-2 Walk at least 6 meters independently (with or without walking aids) Exclusion Criteria: Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia) Physical or psychological comorbidities that affect performance during assessment or intervention Already participating in other physical training in the last 1 month
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yea-Ru Yang, Professor
    Phone
    +886-2-28267279
    Email
    yryang@nycu.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Multicomponent Exercise in People With Dementia

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