Virtual Exercise For Older Adults With Mild Cognitive Impairment

NCT05318703 | Completed DMC

• 1 other identifier: AG059546-02S1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Keywords

tai chi, ehealth, older adults, cognitive impairment

Outcome Measures

Primary Outcomes (12)

• (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 Outcomes (3)

• 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

• Change in quality of life as assessed by EuroQol (EQ-5D-3L)

  baseline, 16 weeks

Study Arms (2)

cognitively enhanced tai ji quan

EXPERIMENTAL

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

Behavioral: tai ji quan

stretching exercise

ACTIVE COMPARATOR

Participants receive a stretching exercise intervention for 16 weeks.

Behavioral: Stretching

Interventions

tai ji quan BEHAVIORAL

cognitively enhanced tai ji quan exercise

cognitively enhanced tai ji quan

Stretching BEHAVIORAL

Stretching exercise

stretching exercise

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Fuzhong Li, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: January 20, 2021
• Primary Completion: August 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the completion of the study.
• 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.

Locations

US (1)