- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05108246
Home-Based Dual-Task Training for Older Adults
June 13, 2023 updated by: Nikhil Satchidanand, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- University at Buffalo, SUNY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Lower-body amputation
- Non-English language speaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Dual-Task Training
|
Simultaneous cognitive-motor training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive Function (Interference inhibition and attention)
Time Frame: baseline, 6 week, 12 weeks
|
Change in performance on the Stroop Color-Word Interference Test
|
baseline, 6 week, 12 weeks
|
|
Change in Cognitive Function (Task-switching and attention)
Time Frame: baseline, 6 week, 12 weeks
|
Change in performance on the Trail-Making Test Sections A and B
|
baseline, 6 week, 12 weeks
|
|
Change in Walking Ability, Lower-Body Strength, and Balance
Time Frame: baseline, 6 weeks, 12 weeks
|
Change in performance on the Short Physical Performance Battery
|
baseline, 6 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dual-Task Performance
Time Frame: baseline, 6 week, 12 weeks
|
Change in the Timed Up and Go Test: Dual Task (single condition, motor condition, and cognitive condition
|
baseline, 6 week, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
October 13, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004857
- UL1TR001412 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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