FallNCT02287740
Prevention of Falls Among Older Adults in Community Settings
A study testing Tai Ji Quan: Moving for Better Balance, Multimodal Exercise and Stretching in people with Fall, run by Oregon Research Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Tai Ji Quan: Moving for Better Balance, Multimodal Exercise and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 30 Mar 2021
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
- planned to leave the study area within the next 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance
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).
Read the detailed 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.
- Conditions
- Fall
- Being tested
- Tai Ji Quan: Moving for Better Balance, Multimodal Exercise, Stretching
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Ji Quan: Moving for Better BalanceBehavioural
The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.
Multimodal ExerciseBehavioural
The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.
StretchingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Ji Quan: Moving for Better Balance | Experimental | This protocol involves training 2 times a week for 6 months. Receives: Behavioral: Tai Ji Quan: Moving for Better Balance |
| Multimodal Exercise | Active comparator | This protocol involves training 2 times a week for 6 months. Receives: Behavioral: Multimodal Exercise |
| Stretching | Sham comparator | This protocol involves participation of 2 times a week for 6 months. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Months
Secondary outcomes (5)
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.
Measured: Baseline, 6 Months
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.
Measured: Baseline, 6 Months
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.
Measured: Baseline, 6 Months
Cognitive function
Montreal Cognitive Assessment (in points). Differences between baseline and 6 months scores will be calculated to assess change.
Measured: Baseline, 6 Months
Cost per fall prevented
determined by calculating total intervention cost estimates divided by number of falls observed during the 6 month intervention.
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion31 Dec 2018
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuzhong Li, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287740
- Sponsor's protocol ID
- 1R01AG045094-01A1
- Status last verified
- Jun 2021
- First submitted
- 28 Oct 2014
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Li F, Harmer P, Eckstrom E, Fitzgerald K, Chou LS, Liu Y. Effectiveness of Tai Ji Quan vs Multimodal and Stretching Exercise Interventions for Reducing Injurious Falls in Older Adults at High Risk of Falling: Follow-up Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e188280. doi: 10.1001/jamanetworkopen.2018.8280.
PubMed 30768195Li F, Harmer P, Eckstrom E, Fitzgerald K, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Cost-Effectiveness of a Therapeutic Tai Ji Quan Fall Prevention Intervention for Older Adults at High Risk of Falling. J Gerontol A Biol Sci Med Sci. 2019 Aug 16;74(9):1504-1510. doi: 10.1093/gerona/glz008.
PubMed 30629121Li F, Harmer P, Fitzgerald K, Eckstrom E, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Effectiveness of a Therapeutic Tai Ji Quan Intervention vs a Multimodal Exercise Intervention to Prevent Falls Among Older Adults at High Risk of Falling: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1301-1310. doi: 10.1001/jamainternmed.2018.3915.
PubMed 30208396
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance
- ClinicalTrials.gov ID
- NCT02287740
- Acronym / sponsor ID
- 1R01AG045094-01A1
- Conditions
- Fall
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Ji Quan: Moving for Better Balance | Experimental | Behavioral: Tai Ji Quan: Moving for Better BalanceThis protocol involves training 2 times a week for 6 months. |
| Multimodal Exercise | Active comparator | Behavioral: Multimodal ExerciseThis protocol involves training 2 times a week for 6 months. |
| Stretching | Sham comparator | Behavioral: StretchingThis protocol involves participation of 2 times a week for 6 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
- planned to leave the study area within the next 12 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 Ji Quan: Moving for Better BalanceThe protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements. | Behavioural | Tai Ji Quan: Moving for Better Balance |
| Multimodal ExerciseThe protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises. | Behavioural | Multimodal Exercise |
| StretchingThe 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. | Behavioural | Stretching |
Primary outcome
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.
5 secondary outcomes
Functional Reach
Time frame: Baseline, 6 Months
Instrumented Timed Up and Go
Time frame: Baseline, 6 Months
Physical Performance
Time frame: Baseline, 6 Months
Cognitive function
Time frame: Baseline, 6 Months
Cost per fall prevented
Time frame: Baseline, 6 Months
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 28 Jun 2021.
- Derived from this study: PubMed 30768195Li F, Harmer P, Eckstrom E, Fitzgerald K, Chou LS, Liu Y. Effectiveness of Tai Ji Quan vs Multimodal and Stretching Exercise Interventions for Reducing Injurious Falls in Older Adults at High Risk of Falling: Follow-up Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e188280. doi: 10.1001/jamanetworkopen.2018.8280.
- Derived from this study: PubMed 30629121Li F, Harmer P, Eckstrom E, Fitzgerald K, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Cost-Effectiveness of a Therapeutic Tai Ji Quan Fall Prevention Intervention for Older Adults at High Risk of Falling. J Gerontol A Biol Sci Med Sci. 2019 Aug 16;74(9):1504-1510. doi: 10.1093/gerona/glz008.
- Derived from this study: PubMed 30208396Li F, Harmer P, Fitzgerald K, Eckstrom E, Akers L, Chou LS, Pidgeon D, Voit J, Winters-Stone K. Effectiveness of a Therapeutic Tai Ji Quan Intervention vs a Multimodal Exercise Intervention to Prevent Falls Among Older Adults at High Risk of Falling: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1301-1310. doi: 10.1001/jamainternmed.2018.3915.
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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.
Fuzhong Li, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Ji Quan: Moving for Better Balance, Multimodal Exercise and Stretching in people with Fall, run by Oregon Research Institute at 1 site 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 7 inclusion and 2 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Change in the number of falls (time frame: Baseline, 6 Months). 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 NCT02287740, which also lists 3 linked publications.
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 28 Jun 2021.