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Virtual Exercise For Older Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tai ji quan
Stretching
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring tai chi, ehealth, older adults, cognitive impairment

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Self-report a change or decline in memory (corroborated by an informant)
  • Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)
  • Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).

Exclusion criteria:

  • Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,
  • Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale
  • Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner
  • Being unable to follow the consent process or sign the study consent form.

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cognitively enhanced tai ji quan

stretching exercise

Arm Description

Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.

Participants receive a stretching exercise intervention for 16 weeks.

Outcomes

Primary Outcome Measures

(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet
assess the extent to which interventionists successfully implement the prespecified exercise training protocol.
number of dropouts from the intervention and study as assessed by a study recording sheet
assess intervention dropout rate and retention rate
Number of participants expressing intervention program satisfaction as assessed by a self-report survey
assess the program acceptability among tai ji quan participants
Change in global cognitive function assessed by Montreal Cognitive Assessment
assess change from baseline cognitive function at 16 weeks
Change in attention and working memory as assessed by Digit Span - forward and backward
assess change from baseline in attention and working memory at 16 weeks
Change in dual-task cost as assessed by Timed Up and Go with a cognitive task
assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks
Change in executive function as assessed by Trail Making B
assess change from baseline executive function at 16 weeks
Change in executive function as assessed by Category Fluency for Animals
assess change from baseline executive function at 16 weeks
Change in cognitive functioning assessed by Everyday Cognition
assess change from baseline cognitive functioning at 16 weeks
Change in physical performance as measured by Timed Up and Go test
assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks
change in leg strength as assessed by 30-second chair stand test
assess change from baseline in leg strength at 16 weeks
Change in balance using a 4-stage balance test
assess change from baseline in balance at 16 weeks

Secondary Outcome Measures

Change in depression as assessed by Geriatric Depression scale
assess change from baseline in the level of depression at 16 weeks
Change in physical activity as assessed by International Physical Activity Questionnaire
assess change from baseline in physical activity at 16 weeks
Change in quality of life as assessed by EuroQol (EQ-5D-3L)
assess change from baseline in quality of life at 16 weeks

Full Information

First Posted
March 23, 2022
Last Updated
March 21, 2023
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05318703
Brief Title
Virtual Exercise For Older Adults With Mild Cognitive Impairment
Official Title
Virtual Exercise Intervention for Older Adults With MCI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

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

5. Study Description

Brief Summary
This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).
Detailed Description
The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
tai chi, ehealth, older adults, cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitively enhanced tai ji quan
Arm Type
Experimental
Arm Description
Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.
Arm Title
stretching exercise
Arm Type
Active Comparator
Arm Description
Participants receive a stretching exercise intervention for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
tai ji quan
Intervention Description
cognitively enhanced tai ji quan exercise
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Stretching exercise
Primary Outcome Measure Information:
Title
(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet
Description
assess the extent to which interventionists successfully implement the prespecified exercise training protocol.
Time Frame
16 weeks
Title
number of dropouts from the intervention and study as assessed by a study recording sheet
Description
assess intervention dropout rate and retention rate
Time Frame
16 weeks
Title
Number of participants expressing intervention program satisfaction as assessed by a self-report survey
Description
assess the program acceptability among tai ji quan participants
Time Frame
16 weeks
Title
Change in global cognitive function assessed by Montreal Cognitive Assessment
Description
assess change from baseline cognitive function at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in attention and working memory as assessed by Digit Span - forward and backward
Description
assess change from baseline in attention and working memory at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in dual-task cost as assessed by Timed Up and Go with a cognitive task
Description
assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in executive function as assessed by Trail Making B
Description
assess change from baseline executive function at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in executive function as assessed by Category Fluency for Animals
Description
assess change from baseline executive function at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in cognitive functioning assessed by Everyday Cognition
Description
assess change from baseline cognitive functioning at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in physical performance as measured by Timed Up and Go test
Description
assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks
Time Frame
baseline, 16 weeks
Title
change in leg strength as assessed by 30-second chair stand test
Description
assess change from baseline in leg strength at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in balance using a 4-stage balance test
Description
assess change from baseline in balance at 16 weeks
Time Frame
baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Change in depression as assessed by Geriatric Depression scale
Description
assess change from baseline in the level of depression at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in physical activity as assessed by International Physical Activity Questionnaire
Description
assess change from baseline in physical activity at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change in quality of life as assessed by EuroQol (EQ-5D-3L)
Description
assess change from baseline in quality of life at 16 weeks
Time Frame
baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Self-report a change or decline in memory (corroborated by an informant) Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant) Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE). Exclusion criteria: Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months, Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner Being unable to follow the consent process or sign the study consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuzhong Li, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan to make IPD and related data dictionaries available.
IPD Sharing Time Frame
12 months after the completion of the study.
IPD Sharing Access Criteria
The de-identified data that support the findings of this study are available from the corresponding author upon reasonable request. Restrictions may apply to preserve participant confidentiality.

Learn more about this trial

Virtual Exercise For Older Adults With Mild Cognitive Impairment

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