Prevention of Falls Among Older Adults in Community Settings

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

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).

Study Overview

• Status: Completed
• Conditions: Fall
• Intervention / Treatment: Behavioral: Tai Ji Quan: Moving for Better Balance; Behavioral: Multimodal Exercise; Behavioral: Stretching

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 670
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Ji Quan: Moving for Better Balance; This protocol involves training 2 times a week for 6 months.	Behavioral: Tai Ji Quan: Moving for Better Balance; The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.
Active Comparator: Multimodal Exercise; This protocol involves training 2 times a week for 6 months.	Behavioral: Multimodal Exercise; The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.
Sham Comparator: Stretching; This protocol involves participation of 2 times a week for 6 months.	Behavioral: Stretching; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Research Institute

Publications and helpful links

General Publications

• Li F, Harmer P, Eckstrom E, Fitzgerald K, Chou LS, Liu Y. Effectiveness of Tai Ji Quan vs Multimodal and Stretching Exercise Interventions for Reducing Injurious Falls in Older Adults at High Risk of Falling: Follow-up Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e188280. doi: 10.1001/jamanetworkopen.2018.8280. Erratum In: JAMA Netw Open. 2019 Mar 1;2(3):e192314.
• Li F, Harmer P, Eckstrom E, Fitzgerald K, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Cost-Effectiveness of a Therapeutic Tai Ji Quan Fall Prevention Intervention for Older Adults at High Risk of Falling. J Gerontol A Biol Sci Med Sci. 2019 Aug 16;74(9):1504-1510. doi: 10.1093/gerona/glz008.
• Li F, Harmer P, Fitzgerald K, Eckstrom E, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Effectiveness of a Therapeutic Tai Ji Quan Intervention vs a Multimodal Exercise Intervention to Prevent Falls Among Older Adults at High Risk of Falling: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1301-1310. doi: 10.1001/jamainternmed.2018.3915.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Exercise
• Other Study ID Numbers: 1R01AG045094-01A1 (U.S. NIH Grant/Contract)