Prevention of Falls Among Older Adults in Community Settings

NCT ID: NCT02287740

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-03-30

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.

Conditions

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Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Ji Quan: Moving for Better Balance

This protocol involves training 2 times a week for 6 months.

Group Type EXPERIMENTAL

Tai Ji Quan: Moving for Better Balance

Intervention Type BEHAVIORAL

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

Multimodal Exercise

This protocol involves training 2 times a week for 6 months.

Group Type ACTIVE_COMPARATOR

Multimodal Exercise

Intervention Type BEHAVIORAL

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

Stretching

This protocol involves participation of 2 times a week for 6 months.

Group Type SHAM_COMPARATOR

Stretching

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Multimodal Exercise

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

Intervention Type 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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fuzhong Li, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

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Oregon Research Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30768195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30629121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30208396 (View on PubMed)

Other Identifiers

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1R01AG045094-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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