Prevention of Falls Among Older Adults in Community Settings

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287740
• Other study ID #: 1R01AG045094-01A1
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: March 30, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall

Intervention

Behavioral:
• 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.
• Multimodal Exercise
The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.
• 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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Reach	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.	Baseline, 6 Months
Secondary	Instrumented Timed Up and Go	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.	Baseline, 6 Months
Secondary	Physical Performance	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.	Baseline, 6 Months
Secondary	Cognitive function	Montreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change.	Baseline, 6 Months
Secondary	Cost per fall prevented	determined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention.	Baseline, 6 Months