Mild Cognitive ImpairmentNCT04059705
Dual-task Training for Function in MCI
A study testing Dual-Task Training in people with Mild Cognitive Impairment, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Dual-Task Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 17 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Dual-Task Training
- Keywords
- motor function, cognitive, attention, dual-task, physical activity, cognition, older adult, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task TrainingBehavioural
Also called ThinkFIT Intervention, SMARTFit Multisensory Fitness System
The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Intervention | Experimental | This study arm will receive the dual-task training program. Receives: Behavioral: Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Function from baseline to 12 weeks
Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
Measured: 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.
Measured: baseline, week 6, week 12
Secondary outcomes (2)
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.
Measured: baseline, week 12
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.
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start4 Apr 2023
- Primary completion10 Sep 2023
- Study completion17 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilizes a one-group design with repeated measures.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikhil Satchidanand, State University of New York at Buffalo
- Investigators
- Nikhil Satchidanand, PhD, Principal investigator, University at Buffalo, State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059705
- Sponsor's protocol ID
- STUDY00003525
- Status last verified
- Nov 2023
- First submitted
- 12 Aug 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dual-task Training on Attention and Motor Function in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04059705
- Acronym / sponsor ID
- STUDY00003525
- Conditions
- Mild Cognitive Impairment
- Keywords
- motor function, cognitive, attention, dual-task, physical activity, cognition, older adult, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 17 Sep 2023 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a one-group design with repeated measures.
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Intervention | Experimental | Behavioral: Dual-Task TrainingThis study arm will receive the dual-task training program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task TrainingAlso: ThinkFIT Intervention, SMARTFit Multisensory Fitness SystemThe ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System. | Behavioural | Dual-Task Intervention |
Primary outcome
Change in Motor Function from baseline to 12 weeks
Time frame: baseline, week 6, week 12
Change in motor function will be assessed prospectively using the Short Physical Performance Battery.
Change in Attention from baseline to 12 weeks
Time frame: baseline, week 6, week 12
Attention will be assessed prospectively using the Stroop Task and Trail-making Test.
2 secondary outcomes
Change in Exercise Self Efficacy from baseline to 12 weeks
Time frame: baseline, week 12
Outcome Expectations for Exercise from baseline to 12 weeks
Time frame: baseline, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil Satchidanand, PhD principal investigator
University at Buffalo, State University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Training in people with Mild Cognitive Impairment, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Function from baseline to 12 weeks (time frame: baseline, week 6, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.