A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment

NCT05725668 | Recruiting

• 1 other identifier: AG074045-01A1
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.

Conditions

Mild Cognitive Impairment; Accidental Falls; Aging

Keywords

Falls; Exercise; Dual tasking

Outcome Measures

Primary Outcomes (1)

• Self-reported number of falls

  This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors

  Monthly, baseline to 6 months (i.e., after end of intervention)

Secondary Outcomes (10)

• Short Physical Performance Battery

  Baseline, 4 months, 6 months, 12 months

• Timed Up and Go (TUG)

  Baseline, 4 months, 6 months, 12 months

• Dual-task walking

  Baseline, 4 months, 6 months, 12 months

• 30-second chair stand

  Baseline, 4 months, 6 months, 12 months

• Montreal Cognitive Assessment (MoCA)

  Baseline, 4 months, 6 months, 12 months

Other Outcomes (6)

• Activity-specific Balance Confidence

  Baseline, 4 months, 6 months, 12 months

• Pittsburgh Sleep Quality Index

  Baseline, 4 months, 6 months, 12 months

• Geriatric Depression Scale

  Baseline, 4 months, 6 months, 12 months

Study Arms (3)

Dual-task taj ji quan

EXPERIMENTAL

This intervention includes training of (a) symmetrical postural tai ji quan forms/movements synchronized with breathing, (b) controlled displacement (weight-shifting) of the body's center of mass over the base of support, (c) dynamic eye-hand movements during whole-body motion, (d) multidirectional (anterior-posterior and medial-lateral) stepping, and (e) rotational ankle sway and self-induced reactive postural recovery actions. The training practices are integrated, gradually over time, with a mix of interactive, cognitively stimulating, dual-task exercises that challenge attention control, working memory, verbalization, response inhibition, processing speed, dual tasking, task switching/prioritization, and spatial orientation and postural awareness.

Behavioral: dual-task tai ji quan

Standard tai ji quan

EXPERIMENTAL

This intervention includes training of tai ji quan forms with synchronized breathing, supplemented by a set of mini-therapeutic exercises. The training involves repeated practice of (a) symmetrical, coordinated, trunk-driven tai ji quan form movements, (b) controlled displacement (weight-shifting) of the body's center of mass over varying sizes of the base of support, (c) dynamic eye-hand movements during whole-body motion, and (d) multidirectional (anterior-posterior and medial-lateral) stepping. As a balance training therapy, movement practices emphasize a dynamic interplay of stabilizing and self-induced destabilizing postural actions and balance exercises that target mobility, stability limits, and sensory integration.

Behavioral: standard tai ji quan

Stretching exercise

EXPERIMENTAL

This active control intervention includes light activities that consist of breathing, stretching, and relaxation exercises. Each exercise session encompasses a variety of light and static stretches for joints and muscles, performed in a seated or standing position. Exercise involves the upper body (arms, neck, upper back, shoulder, back, and chest), lower extremities (quadriceps, hamstrings/calfs, and hips), and gentle and slow trunk rotations. Also included are intermittent light walking, deep abdominal breathing exercises that emphasize inhaling and exhaling to maximum capacity, and progressive relaxation of major muscle groups.

Behavioral: stretching

Interventions

dual-task tai ji quan BEHAVIORAL

dual-task tai ji quan training

Dual-task taj ji quan

standard tai ji quan BEHAVIORAL

standard tai ji quan training

Standard 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:

• being 65 years and older
• having complaint of memory loss
• scoring ≤0.5 on Clinical Dementia Scale
• having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test

You may not qualify if:

• scoring \<24 on the Mini-Mental State Examination
• being able to ambulate independently for household distances
• having medical clearance
• having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
• having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
• being unwilling to be randomized

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Fuzhong Li, Ph.D.

CONTACT

541-484-2123; fuzhongl@ori.org

Study Design

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

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: July 15, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after the study results are published in a peer-reviewed journal and the data sharing plan will end 12 months after the publication.
• Access Criteria: We will share all data that support published results of the trial.

Locations

US (1)