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Home-Based Dual-Task Training for Older Adults

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual-Task Exercise Training
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University at Buffalo, SUNY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dual-Task Training

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in Cognitive Function (Interference inhibition and attention)
Change in performance on the Stroop Color-Word Interference Test
Change in Cognitive Function (Task-switching and attention)
Change in performance on the Trail-Making Test Sections A and B
Change in Walking Ability, Lower-Body Strength, and Balance
Change in performance on the Short Physical Performance Battery

Secondary Outcome Measures

Change in Dual-Task Performance
Change in the Timed Up and Go Test: Dual Task (single condition, motor condition, and cognitive condition

Full Information

First Posted
October 13, 2021
Last Updated
June 13, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05108246
Brief Title
Home-Based Dual-Task Training for Older Adults
Official Title
Home-Based Dual-Task Training to Improve Function in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-Task Training
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Dual-Task Exercise Training
Intervention Description
Simultaneous cognitive-motor training
Primary Outcome Measure Information:
Title
Change in Cognitive Function (Interference inhibition and attention)
Description
Change in performance on the Stroop Color-Word Interference Test
Time Frame
baseline, 6 week, 12 weeks
Title
Change in Cognitive Function (Task-switching and attention)
Description
Change in performance on the Trail-Making Test Sections A and B
Time Frame
baseline, 6 week, 12 weeks
Title
Change in Walking Ability, Lower-Body Strength, and Balance
Description
Change in performance on the Short Physical Performance Battery
Time Frame
baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Dual-Task Performance
Description
Change in the Timed Up and Go Test: Dual Task (single condition, motor condition, and cognitive condition
Time Frame
baseline, 6 week, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University at Buffalo, SUNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Home-Based Dual-Task Training for Older Adults

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