Clinical trial NCT02287740: Prevention of Falls Among Older Adults in Community Settings
Official title: Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: Exercise
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 670
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the number of falls
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Functional Reach
timeFrame: Baseline, 6 Months
measure: Instrumented Timed Up and Go
timeFrame: Baseline, 6 Months
measure: Physical Performance
timeFrame: Baseline, 6 Months
measure: Cognitive function
timeFrame: Baseline, 6 Months
measure: Cost per fall prevented
timeFrame: Baseline, 6 Months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Fuzhong Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.