- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854931
Community Dissemination of Tai Ji Quan
Translating an Effective Fall Prevention Program Into a Community-Based Practice
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(a) 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.
Exclusion Criteria:
(a) severe cognitive deficits defined by Mini-Mental State Evaluation, and (b) unable to commit for the 12 month duration of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Tai Ji Quan
Single aim intervention - 2 twice per week for 48 weeks
|
single aim intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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at the study entry
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach - defined by the total number of older adults agreed to participate
Time Frame: study on-set
|
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.
|
study on-set
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implementation, effectiveness, maintenance
Time Frame: 12 months evaluation on program implementation and effectiveness, and a follow-up at month 18 on program maintenance
|
Assessment of implementation includes fidelity evaluation (compliance rate, completion of required teaching and practice protocol). Effectiveness will be evaluated using falls calendar, physical performance based measures including Functional Reach, Timed Up&Go, 50 foot walk for speed. Maintenance will be evaluated by measuring continued participation among participants (individual level) and participating centers' (center level) willingness to continue the program. |
12 months evaluation on program implementation and effectiveness, and a follow-up at month 18 on program maintenance
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Li 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AG034956-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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