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Clinical Trials/NCT05318703
NCT05318703CompletedNot Applicable

Virtual Exercise Intervention for Older Adults With MCI

Oregon Research Institute1 site in 1 country69 target enrollmentStarted: January 20, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
69
Locations
1
Primary Endpoint
Change in cognitive functioning assessed by Everyday Cognition

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 95 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

cognitively enhanced tai ji quan

Experimental

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

Intervention: tai ji quan (Behavioral)

stretching exercise

Active Comparator

Participants receive a stretching exercise intervention for 16 weeks.

Intervention: Stretching (Behavioral)

Outcomes

Primary Outcomes

Change in cognitive functioning assessed by Everyday Cognition

Time Frame: baseline, 16 weeks

assess change from baseline cognitive functioning at 16 weeks

Change in attention and working memory as assessed by Digit Span - forward and backward

Time Frame: baseline, 16 weeks

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

Time Frame: baseline, 16 weeks

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

Time Frame: baseline, 16 weeks

assess change from baseline executive function at 16 weeks

Change in executive function as assessed by Category Fluency for Animals

Time Frame: baseline, 16 weeks

assess change from baseline executive function at 16 weeks

number of dropouts from the intervention and study as assessed by a study recording sheet

Time Frame: 16 weeks

assess intervention dropout rate and retention rate

Number of participants expressing intervention program satisfaction as assessed by a self-report survey

Time Frame: 16 weeks

assess the program acceptability among tai ji quan participants

Change in global cognitive function assessed by Montreal Cognitive Assessment

Time Frame: baseline, 16 weeks

assess change from baseline cognitive function at 16 weeks

Change in balance using a 4-stage balance test

Time Frame: baseline, 16 weeks

assess change from baseline in balance at 16 weeks

Change in physical performance as measured by Timed Up and Go test

Time Frame: baseline, 16 weeks

assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks

(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

Time Frame: 16 weeks

assess the extent to which interventionists successfully implement the prespecified exercise training protocol.

change in leg strength as assessed by 30-second chair stand test

Time Frame: baseline, 16 weeks

assess change from baseline in leg strength at 16 weeks

Secondary Outcomes

  • Change in quality of life as assessed by EuroQol (EQ-5D-3L)(baseline, 16 weeks)
  • Change in depression as assessed by Geriatric Depression scale(baseline, 16 weeks)
  • Change in physical activity as assessed by International Physical Activity Questionnaire(baseline, 16 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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