Older Aged Adults; BalanceNCT04447001
Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations
A study testing Tai-chi prime (TCP) in people with Older Aged Adults; Balance, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Aged Adults; Balance
- What is being tested?
- Tai-chi prime (TCP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aging and Disability Resource Center (ADRC)
La Crosse, Wisconsin, 54601
Goodman Community Center
Madison, Wisconsin, 53704
Milwaukee County Department on Aging
Milwaukee, Wisconsin, 53205
About this study
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.
- Conditions
- Older Aged Adults; Balance
- Being tested
- Tai-chi prime (TCP)
- Keywords
- Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-chi prime (TCP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Prime (TCP)-session 1 | Experimental | This arm will receive Tai chi prime as an intervention. TCP is a combination of two components: (a) Tai-chi fundamental Adapted Program, and (b) home practice coaching. Receives: Behavioral: Tai-chi prime (TCP) |
| Wait list control-session 2 | No intervention | Wait-list group will be receiving Tai-chi prime intervention after 8 weeks wait time. At week 7, pre-test measures from wait-list group will be used as a control and compared with the post intervention measures of the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants retention
Rate of participant retention in 2 sessions of TCP
Measured: 7 week (for session 1) ,7 week ( for session 2)
Number of days participants practiced Tai-chi at home
Participants will report the average time they are practicing Tai-chi every day at home
Measured: 7 week (for session 1) , 7 week( for session 2)
Secondary outcomes (6)
Change in the time taken to complete 'Trail Making Test Part B'
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.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Change in Activities-specific Balance Confidence (ABC) Scale score
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.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Change in the static balance as measured by Single-leg Balance
Static balance is the ability to maintain the body in some fixed posture.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Change in time taken to complete TUG (Timed Up and Go) test
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.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Change in the time taken to hold tandem stands in the 4-stage balance test
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.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Change in the 'number of times the participant comes to a full standing position in 30 seconds'
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.
Measured: baseline for session 1, 7 weeks (post test for session 1) and 7 weeks (pretest for session 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start31 Aug 2016
- Primary completion1 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Aged Adults; BalanceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betty Chewning, PhD, Principal investigator, University of Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447001
- Sponsor's protocol ID
- 2015-0897
- Other IDs
- A561000, PHARM/PHARMACY/PHARMACY
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30811543
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations
- ClinicalTrials.gov ID
- NCT04447001
- Acronym / sponsor ID
- 2015-0897
- Conditions
- Older Aged Adults; Balance
- Keywords
- Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Prime (TCP)-session 1 | Experimental | Behavioral: Tai-chi prime (TCP)This arm will receive Tai chi prime as an intervention. TCP is a combination of two components: (a) Tai-chi fundamental Adapted Program, and (b) home practice coaching. |
| Wait list control-session 2 | No intervention | –Wait-list group will be receiving Tai-chi prime intervention after 8 weeks wait time. At week 7, pre-test measures from wait-list group will be used as a control and compared with the post intervention measures of the experimental group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai-chi prime (TCP)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. | Behavioural | Tai Chi Prime (TCP)-session 1 |
Primary outcome
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
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Results publication: PubMed 30811543Chewning 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Chewning, PhD principal investigator
University of Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai-chi prime (TCP) in people with Older Aged Adults; Balance, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants retention (time frame: 7 week (for session 1) ,7 week ( for session 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.