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OpenTrials
Completed

NCT Number: NCT04447001

Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations

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.

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Key information

Conditions

Older Aged Adults; Balance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aging and Disability Resource Center (ADRC), La Crosse, Wisconsin, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tai-chi prime (TCP)

Behavioral

TCP is a 6-week twice-weekly simplified tai chi class of 1.5 hr per session with two components: (a) Tai-chi fundamental Adapted Program, and (b) home practice coaching.

Primary outcomes

  1. Rate of participants retention

    Time frame: 7 week (for session 1) ,7 week ( for session 2)

    Rate of participant retention in 2 sessions of TCP

  2. Number of days participants practiced Tai-chi at home

    Time frame: 7 week (for session 1) , 7 week( for session 2)

    Participants will report the average time they are practicing Tai-chi every day at home

Secondary outcomes

  1. Change in the time taken to complete 'Trail Making Test Part B'

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    The Trail Making Test(TMT) is a neuropsychological test of visual attention and task switching. In TMT, the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test being used as the primary performance metric.

  2. Change in Activities-specific Balance Confidence (ABC) Scale score

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    The ABC scale is a self- report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.

    ABC is an 11-point scale and ratings should consist of whole numbers (0-100) for each item. Participants will indicate their level of confidence in doing an activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0%-100%. Total the ratings (possible range = 0 to 1600) and divide by 16 to get each participant's ABC score.

    Scores lower than 50 indicate a low level of functioning, scores above 50 but below 80 indicate a medium level, and those over 80 indicate a high level of functioning.

  3. Change in the static balance as measured by Single-leg Balance

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    Static balance is the ability to maintain the body in some fixed posture.

  4. Change in time taken to complete TUG (Timed Up and Go) test

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    TUG test is a test of mobility and gait. Participant will timed for the following TUG test

    • Participants will be asked to sit back in a standard chair and identify a line 3 meters, or 10 feet away.
    • At 'Go' participant will stand up from the chair.
    • Walk to the line on the floor at your normal pace.
    • Turn.
    • Walk back to the chair at your normal pace.
    • Sit down again.

    Time taken from start to finish will be measured in seconds.

    An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.

  5. Change in the time taken to hold tandem stands in the 4-stage balance test

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    4 stage balance test consists of four standing positions that get progressively harder to maintain.

    instructor will describe and demonstrate each position to the participant.Then the instructor will stand next to the participant, hold their arm,and help them assume the correct position. When the participant will be steady, let go, and time how long they can maintain the position. Instructor will be ready to assist the participant if they lose their balance.

    If the participant can hold a position for 10 seconds without moving their feet or needing support, instructor can ask to go on to the next position. If not, test will be stopped.

    Participants should not use an assistive device (cane or walker) and they should keep their eyes open.

    Participants (older adults) who cannot hold the tandem stand for at least 10 seconds will be at increased risk of falling.

  6. Change in the 'number of times the participant comes to a full standing position in 30 seconds'

    Time frame: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)

    The 30 Second Chair Stand Test can help to indicate if a patient is at risk of falling. Purpose of this test is to test the strength and endurance.

    Instructions to the participant:

    • Sit in the middle of the chair.
    • Place each hand on the opposite shoulder crossed at the wrists.
    • Place your feet flat on the floor.
    • Keep your back straight and keep your arms against your chest.
    • On "Go", rise to a full standing position and then sit back down again.
    • Repeat this for 30 seconds.

    On "Go" timer starts.

    Number of times the participant comes to a full standing position in 30 seconds will be recorded.

    If the participant is over halfway to a standing position when 30 seconds have elapsed, it will be counted as stand.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 25, 2020
Registry last updated
Jun 29, 2020

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.