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Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, TTM, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Cognitive training
New life-style
Sponsored by
Tzu-Ting Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • had a subjective memory complaint
  • MMSE score<16, 21 or 24, based on their years of education (illiterate, 6 or >9 years, respectively, Yeh et al., 2000), but needed >13 or objective memory impairment: AQ>5 or at least one item of IADL dependence
  • able to carry out activities in daily life

Exclusion Criteria:

  • using walking devices
  • depression or dementia diagnosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    comparison group

    exercise group

    cognitive training group

    Arm Description

    No procedure conducted between the pre- and the post-test evaluations, and they received an abridged version of the training after the post-test session.

    The exercise program will include instructions on how to read the program, complete the activities, record their sessions, and exercise safely at first day. To promote incorporating exercising in their daily life routine during the 24-week period, we provided 2 group-based (5-8 participants with 2 instructors at community centers, 60' each) and one home-based (with the exercise program VCD and manual to bring home, 30') exercise program.

    Consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.

    Outcomes

    Primary Outcome Measures

    Mini-Mental State Examination
    The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).
    The Alzheimer's Questionnaire
    Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.
    Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)
    There are 11 items and include general memory and prospective memory sections for analysis the type and frequency of memory problem in elders' daily live. Items are posed in likert scale ranges from 1 (never) to 5 (always). The total score may range from 11-55. A higher score indicates a higher level of memory impaired.

    Secondary Outcome Measures

    Mobility
    The Tinetti Performance-Oriented Mobility Assessment (POMA) is a balance tool that was originally developed for use in the institutionalized, older adult population and contains both a balance and a gait component (Tinetti, 1986). The test comprises 16 items (9 balance-related items and 7 gait-related items), with the highest achievable score being 28 points
    Depressive symptoms
    A short-form Geriatric Depression Scale (GDS) that consisted of 15 questions was the primary outcome measure (Sheikh and Yesavage, 1986). Scores of 0-4 are considered normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression. The Chinese version of the GDS-15 demonstrates high reliability (Liao et al., 2005); in this study, the Cronbach's α is .91.
    Quality of life
    The SF-36 questionnaire was used to measure quality of life. This 36-item questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. Subsequent to summing the Likert-scaled items in the SF-36 survey, scores in each scale are standardized so that they each range from 0 to 100.

    Full Information

    First Posted
    May 22, 2018
    Last Updated
    June 12, 2019
    Sponsor
    Tzu-Ting Huang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03545152
    Brief Title
    Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
    Official Title
    Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    July 31, 2018 (Actual)
    Study Completion Date
    July 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Tzu-Ting Huang

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.
    Detailed Description
    Aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI. Background. Mild cognitive impairment (MCI) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. Although treatments for MCI are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. However, the design and delivery of an appropriate program for people with MCI is challenging for having physical, psychological, cognitive, and social barriers. Design. A prospective randomized control trial. We developed a Physical activity stage-matched intervention (SMI) (1st year), cognitive rehabilitation (2nd year) and New lifestyle program

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, TTM, Physical Activity, Cognitive Rehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    comparison group
    Arm Type
    No Intervention
    Arm Description
    No procedure conducted between the pre- and the post-test evaluations, and they received an abridged version of the training after the post-test session.
    Arm Title
    exercise group
    Arm Type
    Experimental
    Arm Description
    The exercise program will include instructions on how to read the program, complete the activities, record their sessions, and exercise safely at first day. To promote incorporating exercising in their daily life routine during the 24-week period, we provided 2 group-based (5-8 participants with 2 instructors at community centers, 60' each) and one home-based (with the exercise program VCD and manual to bring home, 30') exercise program.
    Arm Title
    cognitive training group
    Arm Type
    Experimental
    Arm Description
    Consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Prescription exercise: frequency, intensity, type, time, and progression (FITT-PRO). 150 min/week (the intensity will be moderate). exercise routine: warming up, resistance training and aerobic exercise training(range of motion and flexibility exercises)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive training
    Intervention Description
    Cognitive training intervention consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.
    Intervention Type
    Behavioral
    Intervention Name(s)
    New life-style
    Intervention Description
    Combination of exercise and cognitive interventions
    Primary Outcome Measure Information:
    Title
    Mini-Mental State Examination
    Description
    The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).
    Time Frame
    8min
    Title
    The Alzheimer's Questionnaire
    Description
    Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.
    Time Frame
    2min
    Title
    Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)
    Description
    There are 11 items and include general memory and prospective memory sections for analysis the type and frequency of memory problem in elders' daily live. Items are posed in likert scale ranges from 1 (never) to 5 (always). The total score may range from 11-55. A higher score indicates a higher level of memory impaired.
    Time Frame
    5min
    Secondary Outcome Measure Information:
    Title
    Mobility
    Description
    The Tinetti Performance-Oriented Mobility Assessment (POMA) is a balance tool that was originally developed for use in the institutionalized, older adult population and contains both a balance and a gait component (Tinetti, 1986). The test comprises 16 items (9 balance-related items and 7 gait-related items), with the highest achievable score being 28 points
    Time Frame
    10min
    Title
    Depressive symptoms
    Description
    A short-form Geriatric Depression Scale (GDS) that consisted of 15 questions was the primary outcome measure (Sheikh and Yesavage, 1986). Scores of 0-4 are considered normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression. The Chinese version of the GDS-15 demonstrates high reliability (Liao et al., 2005); in this study, the Cronbach's α is .91.
    Time Frame
    3min
    Title
    Quality of life
    Description
    The SF-36 questionnaire was used to measure quality of life. This 36-item questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. Subsequent to summing the Likert-scaled items in the SF-36 survey, scores in each scale are standardized so that they each range from 0 to 100.
    Time Frame
    8min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: had a subjective memory complaint MMSE score<16, 21 or 24, based on their years of education (illiterate, 6 or >9 years, respectively, Yeh et al., 2000), but needed >13 or objective memory impairment: AQ>5 or at least one item of IADL dependence able to carry out activities in daily life Exclusion Criteria: using walking devices depression or dementia diagnosis

    12. IPD Sharing Statement

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    Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

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