Prevention of Falls Among Older Adults in Community Settings

NCT02287740 | Completed

• 1 other identifier: 1R01AG045094-01A1
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

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).

Conditions

Fall

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional Reach

  Baseline, 6 Months

• Instrumented Timed Up and Go

  Baseline, 6 Months

• Physical Performance

  Baseline, 6 Months

• Cognitive function

  Baseline, 6 Months

• Cost per fall prevented

  Baseline, 6 Months

Study Arms (3)

Tai Ji Quan: Moving for Better Balance

EXPERIMENTAL

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

Behavioral: Tai Ji Quan: Moving for Better Balance

Multimodal Exercise

ACTIVE COMPARATOR

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

Behavioral: Multimodal Exercise

Stretching

SHAM COMPARATOR

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

Behavioral: Stretching

Interventions

Tai Ji Quan: Moving for Better Balance BEHAVIORAL

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

Tai Ji Quan: Moving for Better Balance

Multimodal Exercise BEHAVIORAL

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

Multimodal Exercise

Stretching 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.

Stretching

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
• planned to leave the study area within the next 12 months.

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (3)

• 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.

  PMID: 30768195 DERIVED

• 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.

  PMID: 30629121 DERIVED

• 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.

  PMID: 30208396 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fuzhong Li, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: March 30, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

US (1)