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Dual-task Training for Function in MCI

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-Task Training
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring motor function, cognitive, attention, dual-task, physical activity, cognition, older adult, mild cognitive impairment

Eligibility Criteria

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

Inclusion Criteria:

  • 65 years of age or older
  • Male or female
  • Mild (23 - 26 points) cognitive impairment as screened by the Montreal Cognitive Assessment
  • Having no absolute contraindications to non-physician supervised exercise as guided by the American College of Sports Medicine and Centers for Disease Control and Prevention.

Exclusion Criteria:

  • Having any condition that prevents safe participation in non-physician supervised exercise as screened using the Physical Activity Readiness Questionnaire for Older Adults
  • Blood pressure >180 mmHg systolic or 100 mmHg diastolic at baseline
  • Presence of severe illness or disability
  • Lower body amputation
  • Cognitive Impairment beyond mild level, preventing provision of informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dual-Task Intervention

    Arm Description

    This study arm will receive the dual-task training program.

    Outcomes

    Primary Outcome Measures

    Change in Motor Function from baseline to 12 weeks
    Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
    Change in Attention from baseline to 12 weeks
    Attention will be assessed prospectively using the Stroop Task and Trail-making Test.

    Secondary Outcome Measures

    Change in Exercise Self Efficacy from baseline to 12 weeks
    Self efficacy for exercise will be assessed using the Self Efficacy for Exercise Scale. Total score is derived by summing the individual scores for each question. Scoring range for this instrument is 0 - 90 points with higher scores representing better outcomes.
    Outcome Expectations for Exercise from baseline to 12 weeks
    Outcome Expectations for exercise will be assessed using the Outcome Expectations for Exercise Scale. This instrument has 9 total items. Total score is derived by summing the responses to these items and dividing by the number of responses. Scoring is out of 9 points, with higher scores demonstrating higher outcomes expectations.

    Full Information

    First Posted
    August 12, 2019
    Last Updated
    May 18, 2023
    Sponsor
    State University of New York at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04059705
    Brief Title
    Dual-task Training for Function in MCI
    Official Title
    The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 4, 2023 (Anticipated)
    Primary Completion Date
    December 4, 2023 (Anticipated)
    Study Completion Date
    January 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo

    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
    Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and severe dementia associated with Alzheimer's disease (AD). In the United States about 20% of older adults have MCI. Loss of cognitive function in aging can have far-reaching and devastating impacts on functional status, independence, and quality of life. Unfortunately, the therapeutic options to slow progression of cognitive decline in aging are limited. Dual-task training; that which involves simultaneous cognitive and motor challenges, is a high-impact potential therapy to slow progressive loss of both motor and cognitive function in aging. The purpose of this trial is to examine the feasibility and therapeutic impact of a novel dual-task physical activity intervention on executive and motor functions among adults, 65 years or older, who have MCI. the investigative team anticipates that findings from this trial will inform development of larger community-based studies focused on improving function and ability to maintain independence in older age.
    Detailed Description
    Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and severe dementia associated with Alzheimer's disease (AD). In the United States about 20% of older adults have MCI, and approximately 15% per year of those with MCI will progress to AD. With our rapidly aging society, we are approaching a public health crisis for which we are not fully prepared. Impaired cognitive function in aging can have far-reaching and devastating impacts on functional status, ability to maintain independence, and overall quality of life. Unfortunately, the therapeutic options to slow progression of cognitive decline in aging are limited. Dual-task training that involves simultaneous cognitive and motor challenges improves certain domains of both cognitive and motor function in older adults with MCI. However, we do not yet know the optimal methods of delivering this high-impact potential therapy in community-based settings with unique limitations and strengths. Therefore, the aims are to; 1) test the feasibility of conducting a community-based dual-task (thinking while exercising) physical activity intervention among adults, 65 years or older, with MCI; and 2) examine the impact of dual-task training on attention and motor function among adults, 65 years or older, with MCI. To accomplish these aims the investigators will conduct an 12-week, dual-task training program using the SmartFit Multisensory Fitness System (Oxnard, CA) among older adults with MCI. Our group-based training program involves two 1-hour training sessions per week, designed to simultaneously engage the mind and body, while promoting self-efficacy. Attention and motor function will be assessed prospectively. The investigators anticipate that findings from this trial will inform development of methods to bring evidence-based, non-invasive therapies into communities in need, in order to preserve function, independence, and quality of life well into older age.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    motor function, cognitive, attention, dual-task, physical activity, cognition, older adult, mild cognitive impairment

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study utilizes a one-group design with repeated measures.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dual-Task Intervention
    Arm Type
    Experimental
    Arm Description
    This study arm will receive the dual-task training program.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dual-Task Training
    Other Intervention Name(s)
    ThinkFIT Intervention, SMARTFit Multisensory Fitness System
    Intervention Description
    The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.
    Primary Outcome Measure Information:
    Title
    Change in Motor Function from baseline to 12 weeks
    Description
    Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
    Time Frame
    baseline, week 6, week 12
    Title
    Change in Attention from baseline to 12 weeks
    Description
    Attention will be assessed prospectively using the Stroop Task and Trail-making Test.
    Time Frame
    baseline, week 6, week 12
    Secondary Outcome Measure Information:
    Title
    Change in Exercise Self Efficacy from baseline to 12 weeks
    Description
    Self efficacy for exercise will be assessed using the Self Efficacy for Exercise Scale. Total score is derived by summing the individual scores for each question. Scoring range for this instrument is 0 - 90 points with higher scores representing better outcomes.
    Time Frame
    baseline, week 12
    Title
    Outcome Expectations for Exercise from baseline to 12 weeks
    Description
    Outcome Expectations for exercise will be assessed using the Outcome Expectations for Exercise Scale. This instrument has 9 total items. Total score is derived by summing the responses to these items and dividing by the number of responses. Scoring is out of 9 points, with higher scores demonstrating higher outcomes expectations.
    Time Frame
    baseline, week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 65 years of age or older Male or female Mild (23 - 26 points) cognitive impairment as screened by the Montreal Cognitive Assessment Having no absolute contraindications to non-physician supervised exercise as guided by the American College of Sports Medicine and Centers for Disease Control and Prevention. Exclusion Criteria: Having any condition that prevents safe participation in non-physician supervised exercise as screened using the Physical Activity Readiness Questionnaire for Older Adults Blood pressure >180 mmHg systolic or 100 mmHg diastolic at baseline Presence of severe illness or disability Lower body amputation Cognitive Impairment beyond mild level, preventing provision of informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nikhil Satchidanand, PhD
    Phone
    716-881-7901
    Email
    ns1@buffalo.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nikhil Satchidanand, PhD
    Organizational Affiliation
    University at Buffalo, State University of New York
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Investigators will allow data and supportive documents to be available to users only under a defined data-sharing agreement that enforces (a) their commitment to using the data only for research purposes and does not identify any individual research participant; (b) the commitment to secure all research data using appropriate technology; (c) prohibition of redistribution of the data to third parties, as well as proper acknowledgement of the data resource, and (d) a commitment to destroying and/or returning the data after analyses have been completed. De-identified data will be maintained on a University at Buffalo server and will be shared via encrypted devices. Co-Investigators may access the data collected as part of their aims. Investigators working on the project will have access to the data only through the principal investigator. The data will be monitored routinely to maintain security, safety, and productivity.
    IPD Sharing Time Frame
    1-year after first publication
    IPD Sharing Access Criteria
    Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.

    Learn more about this trial

    Dual-task Training for Function in MCI

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