Mild Cognitive ImpairmentNCT05108246
Home-Based Dual-Task Training for Older Adults
A study testing Dual-Task Exercise Training in people with Mild Cognitive Impairment, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle… 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 Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or older
- Male or female
- Screened positive for mild cognitive impairment (Montreal Cognitive Assessment score 23 to 26 points
- Having no absolute contraindications to non-physician supervised exercise.
Who cannot join
- Lower-body amputation
- Non-English language speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, SUNY
Buffalo, New York, 14203
About this study
Official title: Home-Based Dual-Task Training to Improve Function in Older Adults
This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Dual-Task Exercise Training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task Exercise TrainingBehavioural
Simultaneous cognitive-motor training
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Training | Experimental | Dual-Task Exercise Receives: Behavioral: Dual-Task Exercise Training |
| Control | No intervention | No Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Balance: Left Limb
Change in performance on the Four-Stage Balance Test: Left Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance
Measured: Pre-test (time 0) and End point (12 weeks)
Change in Balance: Right Limb.
Change in performance on the Four-Stage Balance Test: Right Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance
Measured: Pre-test (time 0) and End point (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Nikhil Satchidanand, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108246
- Sponsor's protocol ID
- STUDY00004857
- Other IDs
- UL1TR001412
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Dual-Task Training to Improve Function in Older Adults
- ClinicalTrials.gov ID
- NCT05108246
- Acronym / sponsor ID
- STUDY00004857
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Training | Experimental | Behavioral: Dual-Task Exercise TrainingDual-Task Exercise |
| Control | No intervention | –No Exercise |
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 or older
- Male or female
- Screened positive for mild cognitive impairment (Montreal Cognitive Assessment score 23 to 26 points
- Having no absolute contraindications to non-physician supervised exercise.
Key exclusion criteria (2 listed)
- Lower-body amputation
- Non-English language speaker
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 Exercise TrainingSimultaneous cognitive-motor training | Behavioural | Dual-Task Training |
Primary outcome
Change in Balance: Left Limb
Time frame: Pre-test (time 0) and End point (12 weeks)
Change in performance on the Four-Stage Balance Test: Left Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance
Change in Balance: Right Limb.
Time frame: Pre-test (time 0) and End point (12 weeks)
Change in performance on the Four-Stage Balance Test: Right Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercise 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 2 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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Balance: Left Limb (time frame: Pre-test (time 0) and End point (12 weeks)). 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 19 Sep 2024.