Older Adults at Risk of FallingNCT01854931
Community Dissemination of Tai Ji Quan
A study testing Tai Ji Quan in people with Older Adults at Risk of Falling, run by Oregon Research Institute at 1 site in United States.
Trial summary
The overarching objective of this project is to assess the potential public health impact of delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through local community dissemination partners (e.g., senior service providers), in the selected counties in the state of Oregon. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults at Risk of Falling
- What is being tested?
- Tai Ji Quan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 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
- 65 years of age or over, (b) physically mobile (i.e., can walk one or two blocks with or without an assistive device), and (c) medical clearance by a healthcare provider.
Who cannot join
- severe cognitive deficits defined by Mini-Mental State Evaluation, and (b) unable to commit for the 12 month duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating an Effective Fall Prevention Program Into a Community-Based Practice
The overarching objective of this project is to assess the potential public health impact of delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through local community dissemination partners (e.g., senior service providers), in the selected counties in the state of Oregon.
Read the detailed description
The program, Tai Chi: Moving for Better Balance, developed by ORI scientists (2003; 2004; 2008, a,b) was implemented in this dissemination project. Class duration was 90 minutes, 2-times per week over a 12-month period. During the initial 2 weeks, practice involved learning and performing 2 forms practiced in one set of 8 repetitions (for each form) and increased to a set of 10 repetitions for up to 5 forms between Week 3 and Week 5. Although additional forms were learned as the intervention progressed, starting in Week 6, training focused on 10-12 repetitions of the combination of forms rather than single forms. Once all 8 forms were learned ( Week 10), training was maintained at between 10-15 repetitions of the 8-form routine. Exercise activities were accompanied by music. Each Tai Chi practice session included (a) a 10-15 minute warm-up, (b) 60 minutes of Tai Chi practice, and (c) a 10-minute cool-down period. Instruction comprised (a) learning new movements and (b) reviewing movements learned from previous sessions. In addition, copies of the videotape/DVD and user's guidebook were distributed to all participants who were encouraged to use these materials for additional home practice.
All participating individuals were assessed at baseline, 6 months (mid-point), 12 months (intervention termination), and 6 months following the intervention (post-intervention follow-up) on measures of health, fall history, functional ability, and quality-of-life. Each evaluation session lasted about one hour and was conducted by a trained research assessor in various centers where these classes were held.
- Conditions
- Older Adults at Risk of Falling
- Being tested
- Tai Ji Quan
- Keywords
- Tai Ji Quan, fall prevention, community dissemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Ji QuanBehavioural
single aim intervention
| Study group | Role | What they receive |
|---|---|---|
| Tai Ji Quan | Other | Single aim intervention - 2 twice per week for 48 weeks Receives: Behavioral: Tai Ji Quan |
What is being measured
The primary outcome is the main question the study is designed to answer.
adoption - defined as community centers that agree to participate (from the total number of centers approached within the dissemination geographic area)
Target senior centers will be contacted to determine the willingness to adopt the program.
Measured: at the study entry
Secondary outcomes (1)
Reach - defined by the total number of older adults agreed to participate
This indicator will be determined at the study on-set by documenting number of individuals who express interest in participating and are eventually enrolled in the program.
Measured: study on-set
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older Adults at Risk of FallingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 511 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
- NCT01854931
- Sponsor's protocol ID
- AG034956-02
- Status last verified
- Nov 2017
- First submitted
- 9 May 2013
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Li F, Harmer P, Fitzgerald K. Implementing an Evidence-Based Fall Prevention Intervention in Community Senior Centers. Am J Public Health. 2016 Nov;106(11):2026-2031. doi: 10.2105/AJPH.2016.303386. Epub 2016 Sep 15.
PubMed 27631751Li F, Harmer P. Protocol for disseminating an evidence-based fall prevention program in community senior centers: evaluation of translatability and public health impact via a single group pre-post study. Implement Sci. 2014 May 26;9:63. doi: 10.1186/1748-5908-9-63.
PubMed 24884784
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating an Effective Fall Prevention Program Into a Community-Based Practice
- ClinicalTrials.gov ID
- NCT01854931
- Acronym / sponsor ID
- AG034956-02
- Conditions
- Older Adults at Risk of Falling
- Keywords
- Tai Ji Quan, fall prevention, community dissemination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 May 2013 (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.
The overarching objective of this project is to assess the potential public health impact of delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through local community dissemination partners (e.g., senior service providers), in the selected counties in the state of Oregon.
Detailed description
The program, Tai Chi: Moving for Better Balance, developed by ORI scientists (2003; 2004; 2008, a,b) was implemented in this dissemination project. Class duration was 90 minutes, 2-times per week over a 12-month period. During the initial 2 weeks, practice involved learning and performing 2 forms practiced in one set of 8 repetitions (for each form) and increased to a set of 10 repetitions for up to 5 forms between Week 3 and Week 5. Although additional forms were learned as the intervention progressed, starting in Week 6, training focused on 10-12 repetitions of the combination of forms rather than single forms. Once all 8 forms were learned ( Week 10), training was maintained at between 10-15 repetitions of the 8-form routine. Exercise activities were accompanied by music. Each Tai Chi practice session included (a) a 10-15 minute warm-up, (b) 60 minutes of Tai Chi practice, and (c) a 10-minute cool-down period. Instruction comprised (a) learning new movements and (b) reviewing movements learned from previous sessions. In addition, copies of the videotape/DVD and user's guidebook were distributed to all participants who were encouraged to use these materials for additional home practice.
All participating individuals were assessed at baseline, 6 months (mid-point), 12 months (intervention termination), and 6 months following the intervention (post-intervention follow-up) on measures of health, fall history, functional ability, and quality-of-life. Each evaluation session lasted about one hour and was conducted by a trained research assessor in various centers where these classes were held.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tai Ji Quan | Other | Behavioral: Tai Ji QuanSingle aim intervention - 2 twice per week for 48 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age or over, (b) physically mobile (i.e., can walk one or two blocks with or without an assistive device), and (c) medical clearance by a healthcare provider.
Key exclusion criteria (1 listed)
- severe cognitive deficits defined by Mini-Mental State Evaluation, and (b) unable to commit for the 12 month duration of the study.
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 Quansingle aim intervention | Behavioural | Tai Ji Quan |
Primary outcome
adoption - defined as community centers that agree to participate (from the total number of centers approached within the dissemination geographic area)
Time frame: at the study entry
Target senior centers will be contacted to determine the willingness to adopt the program.
1 secondary outcome
Reach - defined by the total number of older adults agreed to participate
Time frame: study on-set
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 2 Dec 2017.
- Derived from this study: PubMed 27631751Li F, Harmer P, Fitzgerald K. Implementing an Evidence-Based Fall Prevention Intervention in Community Senior Centers. Am J Public Health. 2016 Nov;106(11):2026-2031. doi: 10.2105/AJPH.2016.303386. Epub 2016 Sep 15.
- Derived from this study: PubMed 24884784Li F, Harmer P. Protocol for disseminating an evidence-based fall prevention program in community senior centers: evaluation of translatability and public health impact via a single group pre-post study. Implement Sci. 2014 May 26;9:63. doi: 10.1186/1748-5908-9-63.
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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 in people with Older Adults at Risk of Falling, 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 1 inclusion and 1 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 2 Dec 2017. 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. 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?
adoption - defined as community centers that agree to participate (from the total number of centers approached within the dissemination geographic area) (time frame: at the study entry). 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 NCT01854931, which also lists 2 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 2 Dec 2017.