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

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.

Official Title
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Dual-Task Training Exercise to Reduce Falls in Older Adults With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment, Accidental Falls, Aging

Intervention / Treatment
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* Behavioral: dual-task tai ji quan
* Behavioral: standard tai ji quan
* Behavioral: stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-task taj ji quan<br>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<br>* dual-task tai ji quan training<br>|
| Experimental: Standard tai ji quan<br>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<br>* standard tai ji quan training<br>|
| Experimental: Stretching exercise<br>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<br>* stretching exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery | Reflects change in lower extremity function with intervention. This is measured by Short Physical Performance Battery which involves three functional tasks: static balance, gait speed, and getting in and out of a chair, with scores ranging from 0 (worst performance) to 12 (best performance). | Baseline, 4 months, 6 months, 12 months | 
| Timed Up and Go (TUG) | Reflects change in lower extremity physical function with intervention. This is measured by the Timed Up and Go test (TUG; in seconds) which assesses mobility and fall risk. The test measures the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower scores represent better lower extremity physical function. | Baseline, 4 months, 6 months, 12 months | 
| Dual-task walking | Reflects change in dual-task costs in gait speed with intervention. The TUG test protocol will be repeated under a dual-task condition where the participant is asked to walk while performing an arithmetic task (i.e., starting at the number 81 and sequentially subtracting 5 from the resulting number). Lower scores on this walk indicate better performance. Dual-task walking cost is defined as the difference between single- and dual-task walking speed, expressed in percentage, with less negative values representing improvement in dual-task walking speed relative to single-task walking. | Baseline, 4 months, 6 months, 12 months | 
| 30-second chair stand | Reflects change in lower extremity strength and endurance with intervention. This is measured by the 30-second chair stand test. The test is conducted by asking the participant to stand up from a chair and sit down fully and to perform as many cycles of sit-to-stand-to-sit as possible in 30 seconds. Higher scores (number of stands) represent higher levels of strength and endurance. | Baseline, 4 months, 6 months, 12 months | 
| Montreal Cognitive Assessment (MoCA) | Reflects change in global cognitive function. This is measured by MoCA which measures cognitive function of multiple domains (attention/concentration, executive functions, short term memory, language, visuospatial abilities, orientation to time and place). MoCA has a total score that ranges from 0 to 30, with higher scores representing better cognitive functioning. | Baseline, 4 months, 6 months, 12 months | 
| Trail Making (A, B) | Reflects change in executive function with intervention. This is measured by Trail Making Test (TMT) which consists of two parts (A and B). In Part A, the participant is asked to count the number (1 through 25) off the screen out loud as quickly as possible. In Part B, the participant is asked to recite numbers and letters in an alternating sequence (1-A-2-B-3-C . . . 12-L) as quickly as possible. Errors are corrected immediate with the clock running. For Parts A and B, scoring is expressed in terms of the time (in seconds) to completion. The difference in time taken to complete Part B versus Part A is calculated to form a measure of executive function, with smaller difference scores indicating better executive function. | Baseline, 4 months, 6 months, 12 months | 
| Category Fluency | Reflects change in memory with intervention. This is measured by a category fluency test in which the participant is asked to generate the names of as many animals as possible in 60 seconds. | Baseline, 4 months, 6 months, 12 months | 
| Forward Digit Span | Reflects change in attention with intervention. This is measured by Forward Digit Span test. During the test, the participant is asked to repeat a series of digits in the order given. The maximum raw score is 16, with higher scores indicating better attention. | Baseline, 4 months, 6 months, 12 months | 
| Backward Digit Span | Reflects change in short-term working memory with intervention. This is measured by Backward Digit Span test. During the test, the participant is asked to repeat a series of digits in reverse order. The maximum raw score is 16, with higher scores indicating better memory. | Baseline, 4 months, 6 months, 12 months | 
| Proportion of fallers | Number of fallers from participants at 6 months in each intervention group | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Exercise, Dual tasking