Clinical trial NCT04447001: Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations
Official title: Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Aged Adults; Balance
Keywords: Tai Chi
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 197
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to immediately begin short 6-week modified tai chi course along with a personal home practice plan to receive greater Tai chi dose(session 1) or complete a 8-week wait (wait-list control). Wait-list group will be receiving Tai-chi prime intervention after 8 weeks wait time (session-2).

In addition to the pre-post tests of TCF sessions to explore TCF effectiveness, pre-test scores for session 2 are compared to post-test scores of session 1 participants since both are collected at nearly the same time.
Primary purpose: PREVENTION

Brief summary: This study will evaluate how best to disseminate and implement Tai Chi Fundamentals® (TCF) in community settings for older adults with balance problems. TCF is a program designed for older adults with pain and physical limitations to enhance balance, coordination, strength and endurance. Investigator will evaluate program implementation including Aging and Disability Resource Center (ADRC) uptake, reach, feasibility, teaching fidelity, and exercise adherence and also collect outcomes including leg strength, balance, walking ability and executive function before and after the 6-week session. The final product of this study will be recommendations to address key barriers and facilitators for implementation of TCF by community organizations serving older adults.

The primary aim for this study is to evaluate the program implementation. This is not an efficacy study. Within the limits of a Dissemination and Implementation grant budget, Investigators do take advantage of a natural experiment even if it is not the primary aim of this study. By doing so investigators plan to establish the feasibility of this multi-site data collection plan for future studies. Based on the study settings, study team will get a chance to explore the effect of TCF in real world settings since two sessions can be held in a fall season and a spring season. In addition to the pre-post tests of TCF sessions to explore TCF effectiveness, pre-test scores for session 2 are compared to post-test scores of session 1 participants since both are collected at nearly the same time. The larger sample will be for the within group pre-post comparison analyses. This will be a valuable opportunity to test data collection procedures for future trials.


Eligibility criteria: Inclusion Criteria:

* being 65 years and older
* dwelling independently in the community
* agreeing to be randomized
* reporting a fall (to the ground or lower level in the last year or having a strong fear of falling.

Exclusion Criteria:

* using a walker indoors
* having a terminal illness
* being hospitalized or in a nursing home in the past 2 months
* anticipated absence from two tai chi sessions and
* receiving physical therapy or a community course or balance exercise program for falls prevention in the prior 2 months

Primary outcomes:
measure: Rate of participants retention
timeFrame: 7 week (for session 1) ,7 week ( for session 2)
measure: Number of days participants practiced Tai-chi at home
timeFrame: 7 week (for session 1) , 7 week( for session 2)
Secondary outcomes:
measure: Change in the time taken to complete 'Trail Making Test Part B'
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
measure: Change in Activities-specific Balance Confidence (ABC) Scale score
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
measure: Change in the static balance as measured by Single-leg Balance
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
measure: Change in time taken to complete TUG (Timed Up and Go) test
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
measure: Change in the time taken to hold tandem stands in the 4-stage balance test
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
measure: Change in the 'number of times the participant comes to a full standing position in 30 seconds'
timeFrame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Aging and Disability Resource Center (ADRC)
state: Wisconsin
city: Madison
country: United States
facility: Goodman Community Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee County Department on Aging
state: Wisconsin
Study officials:
affiliation: University of Madison
name: Betty Chewning, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chewning B, Hallisy KM, Mahoney JE, Wilson D, Sangasubana N, Gangnon R. Disseminating Tai Chi in the Community: Promoting Home Practice and Improving Balance. Gerontologist. 2020 May 15;60(4):765-775. doi: 10.1093/geront/gnz006.