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Agility Training and Its Relations in Elderly Adults With and Without MCI

Primary Purpose

Elderly Adults, Mild Cognitive Impairment, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health education
Multicomponent training
Agility training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly Adults focused on measuring Aging, Agility training, Cognition function, Fall, Mild Cognitive Impairment, Motor function

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Part 1:

Inclusion Criteria:

  1. has a score of ≥ 24 on the Mini-Mental State Examination (MMSE)
  2. able to walk independently for more than 30 meters without assistive aids
  3. able to follow orders

Exclusion Criteria:

  1. poorly-controlled or unstable systematic disease
  2. has a history of central nervous system disease
  3. currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
  4. subjects with achromatopsia

Part 2:

Inclusion Criteria:

  1. older than 65 years old
  2. score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26
  3. able to walk independently for more than 30 meters without assistive aids
  4. able to follow orders

Exclusion Criteria:

  1. poorly controlled or unstable systematic disease
  2. has a history of central nervous system disease
  3. currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
  4. has other medical conditions for which exercise is contraindicated
  5. subjects with achromatopsia

Part 3:

Inclusion Criteria:

  1. older than 65 years old
  2. score of Mini-Mental State Examination (MMSE) ≥ 24
  3. able to walk independently for more than 30 meters without assistive aids
  4. able to follow orders

Exclusion Criteria:

  1. poorly controlled or unstable systematic disease
  2. has a history of central nervous system disease
  3. currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
  4. has other medical conditions for which exercise is contraindicated
  5. subjects with achromatopsia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    No Intervention

    No Intervention

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Healthy adults

    Healthy elderly and mild cognitive impairment elderly

    Mild cognitive impairment elderly with health education

    Mild cognitive impairment elderly with multicomponent training

    Mild cognitive impairment elderly with agility training

    Healthy elderly with health education

    Healthy elderly with multicomponent training

    Healthy elderly with agility training

    Arm Description

    Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.

    Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.

    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.

    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.

    Outcomes

    Primary Outcome Measures

    Agility Challenge for the Elderly (ACE)
    An agility course developed for a 9m x 18m volleyball court and includes three segments that each aim to test a specific aspect of agility, including stop-and-go, change of direction, and spatial orientation.

    Secondary Outcome Measures

    Fall history and fear of falls
    Fall history will be recorded by the number of fall episodes in the past 6 months and whether it caused injury.
    Quality of life (QOL)
    Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
    Brain activation
    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the hemodynamics of brain areas associated with the agility test, cognitive tasks, and single and dual task walking test.
    Montreal Cognitive Assessment (MoCA)
    MoCA contains 16 items and 11 categories to assess multiple cognitive domains, is a screening instrument for MCI, and its validity has been established in various clinical groups and countries.
    Mental set shifting
    The Wisconsin Card Sorting Test (WCST) will be used to measure participants' ability to shift their cognitive ability in response to the demands of environment.
    Working memory
    The backward digit span test (DGS) will be used to measure working memory.
    Selective attention and inhibition
    The Stroop Color and Word Test (SCWT) will be used to measure selective attention.
    Motor Function
    Walking performance, normal walking, cognitive dual-task walking, muscle strength of bilateral lower limbs, five times sit to stand test, timed up and go, quiet static standing task, and the 360° turning task, flexibility, 6-minute walk test (6WMT).

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    September 11, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05537363
    Brief Title
    Agility Training and Its Relations in Elderly Adults With and Without MCI
    Official Title
    The Effects of an Agility Training and Its Relation to Motor, Cognitive Performance and Fall Risk in Elderly Adults With and Without Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 10, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    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
    The following three-part proposal will focus on the effects of agility training as well as the relationship between agility ability and motor and cognitive function, and risk of falls in elderly adults with or without mild cognitive impairment (MCI). Part I is a cross-sectional study design that will assess the level of agility in healthy young adults, healthy elderly adults, and elderly adults with MCI to determine the effect of aging and cognition decline on agility and the relations between agility, cognitive, and motor functions. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests, as well as an agility test. Cognitive function tests include tests of global cognition, working memory, mental set shifting, and selective attention. Motor function tests include tests of single and dual task walking, strength, power, balance, flexibility, and endurance. The agility test contains stop-and-go, change of direction, and spatial orientation components. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the agility test, cognitive tests, and single and dual task walking. Results from all tests will be used to determine the motor, cognitive, and other predictive factors associated with agility performance, and will be used in the design of the training program in Part II and III. Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a multicomponent training and an agility training protocol on agility, motor, and cognitive function in elderly adults with and without MCI. Seventy-five elderly adults with MCI (Part II) and seventy-five healthy elderly (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor, cognitive, and agility tests used in Part I, information on history of falls, falls efficacy, and quality of life will be assessed for each participant. Brain activation will be assessed during the agility test, cognitive tests, and single and dual task walking assessments using fNIRS. Participants will be randomly allocated into one of three groups: the control group, the multicomponent training group, or the agility training group (n=25 in each group). Intervention will be executed at a frequency of 45 minutes per session, 2 times a week for 8 weeks. The control group will receive home-based health education guidelines. The multicomponent training group will engage in 3 to 4 exercises each training session comprising the influencing factors of agility, and the agility training group will engage in integrated task-specific training. A post-test will be conducted after the 8-week intervention, and 1-month, 6-month, and 12-month follow-ups will be conducted for elderly adults with MCI. The healthy elderly adults will be assessed after the intervention and at the 1-month follow-up after training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elderly Adults, Mild Cognitive Impairment, Healthy
    Keywords
    Aging, Agility training, Cognition function, Fall, Mild Cognitive Impairment, Motor function

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy adults
    Arm Type
    No Intervention
    Arm Description
    Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.
    Arm Title
    Healthy elderly and mild cognitive impairment elderly
    Arm Type
    No Intervention
    Arm Description
    Year 1: To assess levels of agility and agility performance in relation to the motor and cognitive abilities of healthy young adults, healthy elderly, and elderly with MCI.
    Arm Title
    Mild cognitive impairment elderly with health education
    Arm Type
    Active Comparator
    Arm Description
    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.
    Arm Title
    Mild cognitive impairment elderly with multicomponent training
    Arm Type
    Experimental
    Arm Description
    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.
    Arm Title
    Mild cognitive impairment elderly with agility training
    Arm Type
    Experimental
    Arm Description
    Year 2: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility, motor, and cognitive function in elderly with MCI.
    Arm Title
    Healthy elderly with health education
    Arm Type
    Active Comparator
    Arm Description
    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.
    Arm Title
    Healthy elderly with multicomponent training
    Arm Type
    Experimental
    Arm Description
    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.
    Arm Title
    Healthy elderly with agility training
    Arm Type
    Experimental
    Arm Description
    Year 3: To determine the short and long-term effects of a multicomponent training protocol and an agility training protocol on agility ability, motor, and cognitive function in healthy elderly adults.
    Intervention Type
    Other
    Intervention Name(s)
    Health education
    Intervention Description
    Participants in the control group will receive health educational guidelines. Guideline contents include home-based exercise program, nutrition recommendations, and fall prevention education.
    Intervention Type
    Other
    Intervention Name(s)
    Multicomponent training
    Intervention Description
    Multicomponent exercises will be designed according to the results of Part I of our study. Results of Part I of this study will determine the contributing factors of agility, such as muscle strength, endurance, and cognitive function. A physical therapist will train the participants 3-4 exercises (3-4 factors) in each session. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
    Intervention Type
    Other
    Intervention Name(s)
    Agility training
    Intervention Description
    The agility-based task-specific exercises will be conducted in this group and will incorporate stop-and-go, change in direction, change in velocity, acceleration and deceleration training. There are four training configurations with 3 levels of difficulty, which will be manipulated by increasing speed, distance, number of repetitions, number of directions, congruency, and/or complexity of the task, or by decreasing the number and duration of the rest intervals. The physical therapist will adjust the difficulty of each exercise according to the participant's ability and condition.
    Primary Outcome Measure Information:
    Title
    Agility Challenge for the Elderly (ACE)
    Description
    An agility course developed for a 9m x 18m volleyball court and includes three segments that each aim to test a specific aspect of agility, including stop-and-go, change of direction, and spatial orientation.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Secondary Outcome Measure Information:
    Title
    Fall history and fear of falls
    Description
    Fall history will be recorded by the number of fall episodes in the past 6 months and whether it caused injury.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Quality of life (QOL)
    Description
    Quality of life (QOL) will be evaluated by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Brain activation
    Description
    A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the hemodynamics of brain areas associated with the agility test, cognitive tasks, and single and dual task walking test.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    MoCA contains 16 items and 11 categories to assess multiple cognitive domains, is a screening instrument for MCI, and its validity has been established in various clinical groups and countries.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Mental set shifting
    Description
    The Wisconsin Card Sorting Test (WCST) will be used to measure participants' ability to shift their cognitive ability in response to the demands of environment.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Working memory
    Description
    The backward digit span test (DGS) will be used to measure working memory.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Selective attention and inhibition
    Description
    The Stroop Color and Word Test (SCWT) will be used to measure selective attention.
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month
    Title
    Motor Function
    Description
    Walking performance, normal walking, cognitive dual-task walking, muscle strength of bilateral lower limbs, five times sit to stand test, timed up and go, quiet static standing task, and the 360° turning task, flexibility, 6-minute walk test (6WMT).
    Time Frame
    Part 1:Baseline; Part 2: Pre-intervention, 8 weeks, 12 weeks, 8-month, and 14-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Part 1: Inclusion Criteria: has a score of ≥ 24 on the Mini-Mental State Examination (MMSE) able to walk independently for more than 30 meters without assistive aids able to follow orders Exclusion Criteria: poorly-controlled or unstable systematic disease has a history of central nervous system disease currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain subjects with achromatopsia Part 2: Inclusion Criteria: older than 65 years old score of Mini-Mental State Examination (MMSE) ≥ 24 and score of Montreal Cognitive Assessment (MoCA) ≤ 26 able to walk independently for more than 30 meters without assistive aids able to follow orders Exclusion Criteria: poorly controlled or unstable systematic disease has a history of central nervous system disease currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain has other medical conditions for which exercise is contraindicated subjects with achromatopsia Part 3: Inclusion Criteria: older than 65 years old score of Mini-Mental State Examination (MMSE) ≥ 24 able to walk independently for more than 30 meters without assistive aids able to follow orders Exclusion Criteria: poorly controlled or unstable systematic disease has a history of central nervous system disease currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain has other medical conditions for which exercise is contraindicated subjects with achromatopsia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Ci Liu, PhD
    Phone
    +886233668135
    Email
    yanciliu@ntu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Ci Liu, PhD
    Organizational Affiliation
    National Taiwan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Agility Training and Its Relations in Elderly Adults With and Without MCI

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