- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059705
Dual-task Training for Function in MCI
The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nikhil Satchidanand, PhD
- Phone Number: 716-881-7901
- Email: ns1@buffalo.edu
Study Locations
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New York
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Buffalo, New York, United States, 14223
- Buffalo-Niagara YMCA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual-Task Intervention
This study arm will receive the dual-task training program.
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The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Motor Function from baseline to 12 weeks
Time Frame: baseline, week 6, week 12
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Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
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baseline, week 6, week 12
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Change in Attention from baseline to 12 weeks
Time Frame: baseline, week 6, week 12
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Attention will be assessed prospectively using the Stroop Task and Trail-making Test.
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baseline, week 6, week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Exercise Self Efficacy from baseline to 12 weeks
Time Frame: baseline, week 12
|
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.
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baseline, week 12
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Outcome Expectations for Exercise from baseline to 12 weeks
Time Frame: baseline, week 12
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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.
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baseline, week 12
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Collaborators and Investigators
Investigators
- Principal Investigator: Nikhil Satchidanand, PhD, University at Buffalo, State University of New York
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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