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

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
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
NCT ID
NCT04059705
First Posted
August 12, 2019
Last Updated
May 18, 2023
Sponsor
State University of New York at Buffalo
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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