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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287740
Enrollment
670
Registered
2014-11-11
Start date
2014-11-30
Completion date
2021-03-30
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall

Keywords

Exercise

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.

Interventions

The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.

The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.

BEHAVIORALStretching

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.

Sponsors

Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the number of fallsBaseline, 6 MonthsUsing 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.

Secondary

MeasureTime frameDescription
Functional ReachBaseline, 6 Monthsassessing 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.
Instrumented Timed Up and GoBaseline, 6 Monthsassessing 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.
Physical PerformanceBaseline, 6 MonthsThe 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.
Cognitive functionBaseline, 6 MonthsMontreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change.
Cost per fall preventedBaseline, 6 Monthsdetermined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026