Prevention of Falls Among Older Adults in Community Settings

Study Overview
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Brief Summary
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Objective: To conduct a comparative efficacy and cost-effectiveness study of an evidence-based fall prevention program-Tai Ji Quan: Moving for Better Balance (TJQMBB).

Detailed Description
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To determine the effectiveness and cost-effectiveness of the two evidence-based exercise programs (Multimodal Exercise,TJQMBB) relative to stretching, a proxy for a minimum practice standard, in reducing falls among older adults at risk of falling.

Official Title
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Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance

Conditions
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Fall

Intervention / Treatment
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* Behavioral: Tai Ji Quan: Moving for Better Balance
* Behavioral: Multimodal Exercise
* Behavioral: Stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 70 years or older living independently in the community at least one fall in the preceding 12 months and a referral from a healthcare provider indicating the participant is at risk of falls due to gait/balance impairment or medication use or impaired mobility as evidenced by Timed Up and Go result of >13.5 seconds no participation in daily and/or structured vigorous physical activity or walking for exercise that lasted 15 minutes or longer at a time or muscle-strengthening activities on 2 or more days a week in the previous 3 months walking independently, with or without the use of an assistive device, no severe cognitive impairment (Mini-Mental State Examination score ≥20) able to exercise safely as determined by their healthcare provider, a willingness to be randomly assigned to an intervention condition and complete the 6-month intervention and 6 month follow-up. Exclusion Criteria: any medical or physical conditions deemed unacceptable by their physician or healthcare provider, planned to leave the study area within the next 12 months.

Ages Eligible for Study
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Minimum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Ji Quan: Moving for Better Balance<br>This protocol involves training 2 times a week for 6 months. | Behavioral: Tai Ji Quan: Moving for Better Balance<br>* The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.<br>|
| Active Comparator: Multimodal Exercise<br>This protocol involves training 2 times a week for 6 months. | Behavioral: Multimodal Exercise<br>* The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.<br>|
| Sham Comparator: Stretching<br>This protocol involves participation of 2 times a week for 6 months. | Behavioral: Stretching<br>* The protocol represents a minimum standard of practice for exercises for older adults with activities consisting primarily of seated exercises accompanied by breathing, stretching, and relaxation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of falls | Using a daily diary fall calendar, falls reported by participants across the 24-week surveillance period will be collected, starting from the date of first intervention class and continuing until participants withdrew, had died or were lost to follow-up. | Baseline, 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Reach | assessing the maximal distance (in inch) participants one can reach forward, beyond arm's length, while maintaining a fixed based of support in the standing position. Differences between baseline and 6 months scores will be calculated to assess change. | Baseline, 6 Months | 
| Instrumented Timed Up and Go | assessing the time to complete a series of functional tasks (sit-to-stand, 180 degree turn, turn-to-sit.) while walking through a 7-meter walkway (7 meters towards a line, turn, and 7 meters towards the chair). The measure is assessed in second. Differences between baseline and 6 months scores will be calculated to assess change. | Baseline, 6 Months | 
| Physical Performance | The physical performance measure consists of 4-meter walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance). A summary score ranging from 0 (worst performance) to 12 (best performances) will be calculated by summing the 3 components scores. | Baseline, 6 Months | 
| Cognitive function | Montreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change. | Baseline, 6 Months | 
| Cost per fall prevented | determined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention. | Baseline, 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise