Virtual Exercise For Older Adults With Mild Cognitive Impairment

Virtual Exercise Intervention for Older Adults With MCI

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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: tai ji quan; Behavioral: Stretching

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cognitively enhanced tai ji quan; Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.	Behavioral: tai ji quan; cognitively enhanced tai ji quan exercise
Active Comparator: stretching exercise; Participants receive a stretching exercise intervention for 16 weeks.	Behavioral: Stretching; Stretching exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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.	16 weeks
number of dropouts from the intervention and study as assessed by a study recording sheet	assess intervention dropout rate and retention rate	16 weeks
Number of participants expressing intervention program satisfaction as assessed by a self-report survey	assess the program acceptability among tai ji quan participants	16 weeks
Change in global cognitive function assessed by Montreal Cognitive Assessment	assess change from baseline cognitive function at 16 weeks	baseline, 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	baseline, 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	baseline, 16 weeks
Change in executive function as assessed by Trail Making B	assess change from baseline executive function at 16 weeks	baseline, 16 weeks
Change in executive function as assessed by Category Fluency for Animals	assess change from baseline executive function at 16 weeks	baseline, 16 weeks
Change in cognitive functioning assessed by Everyday Cognition	assess change from baseline cognitive functioning at 16 weeks	baseline, 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	baseline, 16 weeks
change in leg strength as assessed by 30-second chair stand test	assess change from baseline in leg strength at 16 weeks	baseline, 16 weeks
Change in balance using a 4-stage balance test	assess change from baseline in balance at 16 weeks	baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression as assessed by Geriatric Depression scale	assess change from baseline in the level of depression at 16 weeks	baseline, 16 weeks
Change in physical activity as assessed by International Physical Activity Questionnaire	assess change from baseline in physical activity at 16 weeks	baseline, 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	baseline, 16 weeks

Collaborators and Investigators

• Sponsor: Oregon Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: tai chi, ehealth, older adults, cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AG059546-02S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No