Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults

Study Overview
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Brief Summary
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To examine two different exercise programs in reducing incidence of falls among community-dwelling older adults

Detailed Description
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This is a randomized controlled trial aimed at determining the effectiveness of a virtual and home-based tai ji quan intervention vs. a virtual and home-based multimodal exercise intervention in reducing incidence of falls among community-dwelling older adults at high risk of falling

Official Title
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A Remotely Delivered Tai Ji Quan Intervention to Reduce Incidence of Falls in High Risk Community-Dwelling Older Adults

Conditions
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Accidental Fall

Intervention / Treatment
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* Behavioral: Virtual tai ji quan: moving for better balance intervention (V-TJQMBB)
* Behavioral: Virtual multimodal exercise intervention (V-Multimodal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 65 and 90 years and having had 1 or more falls in the preceding 12 months or having a score ≥12 seconds on the Timed Up&Go (TUG) test. Exclusion Criteria: showing a diagnosis of dementia or significant cognitive impairment, as indicated by a score of <24 on the Mini Mental State Evaluation (MMSE, range: 0-30); being unable to ambulate independently for household distances; (c) having no medical clearance; having participated in any regular and structured tai ji quan-based or multicomponent exercise programs (≥2 times weekly) in the preceding 6 months; having any physical condition that would preclude participation in moderate-intensity exercise; and being unwilling to commit to the duration of the intervention or accept group assignment.

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 |
| --- | --- |
| Active Comparator: Virtual tai ji quan<br>Participants participating are intervened with practice and drills of tai ji quan forms and associated movements. Training focuses on lower-extremity strength, postural control, and mobility, with an emphasis on weight bearing and weight shifting, extending and controlling the body's center of mass over its base of support; self-induced movement perturbation; gait preparation, initiation, locomotion, and termination; and sensory integration. The exercise training also emphasizes connecting tai ji quan forms to transitional movements that are associated with performing daily activities. Each session includes brief movement-based warm-ups and light breathing cool-down exercises. | Behavioral: Virtual tai ji quan: moving for better balance intervention (V-TJQMBB)<br>* This intervention involves a tai ji quan exercise program, named tai ji quan: moving for better balance<br>* Other names: V-TJQMBB;|
| Active Comparator: Virtual multimodal exercise<br>Participants participating are intervened with a multicomponent exercise program that involves light walking, strength, postural control, and flexibility exercises. Walking exercises include amble forward and backward walk, long strides, heel-toe walking, narrow- and wide-base walking, and sidestepping. Strength training includes single- and multi-joint exercises such as semi-squats, lunging forward and sideways, and toe stands that involve exercising ankle dorsiflexors, knee extensors, and hip abductors. Balance training involves semi-tandem foot-standing, heel-toe and line walking, single-leg standing, alternation of the base of support, weight transfers, toe and heel movements, and various reaching and stretching movements away from the center of the base of support. Flexibility exercises include a static stretching routine of major upper and lower body muscle groups. Each session includes brief movement-based warm-ups and light breathing cool-down exercises. | Behavioral: Virtual multimodal exercise intervention (V-Multimodal)<br>* This intervention involves a multimodal exercise program that consists of balance, strength, light walking, and stretching exercises<br>* Other names: V-Multimodal;|

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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | This measure reflects change in lower extremity function with intervention. This is measured by SPPB 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, and 12 months | 
| Timed up and Go (TUG) | Reflects change in mobility performance with intervention. This is measured by TUG (measured 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, and 12 months | 
| 30-second chair stand | Reflects change in lower-extremity strength with intervention. This is measured by a 30-second chair stand test. | Baseline, 4 months, 6 months, and 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. 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, and 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, and 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, and 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, and 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, and 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, and 12 months | 
| Proportion of fallers | Number of fallers from the participants in each intervention group | At 6 months |