Clinical trial NCT05318703: Virtual Exercise For Older Adults With Mild Cognitive Impairment
Official title: Virtual Exercise Intervention for Older Adults With MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: tai chi, ehealth, older adults, cognitive impairment
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: (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
timeFrame: 16 weeks
measure: number of dropouts from the intervention and study as assessed by a study recording sheet
timeFrame: 16 weeks
measure: Number of participants expressing intervention program satisfaction as assessed by a self-report survey
timeFrame: 16 weeks
measure: Change in global cognitive function assessed by Montreal Cognitive Assessment
timeFrame: baseline, 16 weeks
measure: Change in attention and working memory as assessed by Digit Span - forward and backward
timeFrame: baseline, 16 weeks
measure: Change in dual-task cost as assessed by Timed Up and Go with a cognitive task
timeFrame: baseline, 16 weeks
measure: Change in executive function as assessed by Trail Making B
timeFrame: baseline, 16 weeks
measure: Change in executive function as assessed by Category Fluency for Animals
timeFrame: baseline, 16 weeks
measure: Change in cognitive functioning assessed by Everyday Cognition
timeFrame: baseline, 16 weeks
measure: Change in physical performance as measured by Timed Up and Go test
timeFrame: baseline, 16 weeks
measure: change in leg strength as assessed by 30-second chair stand test
timeFrame: baseline, 16 weeks
measure: Change in balance using a 4-stage balance test
timeFrame: baseline, 16 weeks
Secondary outcomes:
measure: Change in depression as assessed by Geriatric Depression scale
timeFrame: baseline, 16 weeks
measure: Change in physical activity as assessed by International Physical Activity Questionnaire
timeFrame: baseline, 16 weeks
measure: Change in quality of life as assessed by EuroQol (EQ-5D-3L)
timeFrame: baseline, 16 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Fuzhong Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: