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
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedStudy Start
First participant enrolled
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2023
CompletedNovember 30, 2023
November 1, 2023
5 months
August 12, 2019
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Motor Function from baseline to 12 weeks
Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
baseline, week 6, week 12
Change in Attention from baseline to 12 weeks
Attention will be assessed prospectively using the Stroop Task and Trail-making Test.
baseline, week 6, week 12
Secondary Outcomes (2)
Change in Exercise Self Efficacy from baseline to 12 weeks
baseline, week 12
Outcome Expectations for Exercise from baseline to 12 weeks
baseline, week 12
Study Arms (1)
Dual-Task Intervention
EXPERIMENTALThis study arm will receive the dual-task training program.
Interventions
The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Buffalo-Niagara YMCA
Buffalo, New York, 14223, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikhil Satchidanand, PhD
University at Buffalo, State University of New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 16, 2019
Study Start
April 4, 2023
Primary Completion
September 10, 2023
Study Completion
September 17, 2023
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 1-year after first publication
- 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.
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.