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Completed

NCT Number: NCT02287740

Prevention of Falls Among Older Adults in Community Settings

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).

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Key information

Conditions

Fall Behavior Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Multimodal exercise

Behavioral

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

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.

Primary outcomes

  1. Change in the number of falls

    Time frame: Baseline, 6 Months

    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.

Secondary outcomes

  1. Functional Reach

    Time frame: Baseline, 6 Months

    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.

  2. Instrumented Timed Up and Go

    Time frame: Baseline, 6 Months

    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.

  3. Physical Performance

    Time frame: Baseline, 6 Months

    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.

  4. Cognitive function

    Time frame: Baseline, 6 Months

    Montreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change.

  5. Cost per fall prevented

    Time frame: Baseline, 6 Months

    determined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Nov 11, 2014
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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