An interventional study of Tai Chi: Moving for Better Balance in Accidental Falls, sponsored by West Virginia University. Completed at 9 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by West Virginia University · Not applicable, Interventional, and Prevention
Falls are the leading cause of death and injuries in adults over age 65 both nationally and in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as arthritis, are strong risk factors for falls in this population. West Virginia has a higher than average fall rate, the second oldest population, the greatest proportion of inactive adults, and the second highest prevalence of arthritis in the US. Thus, older adults in rural West Virginia are at high risk for falls and in great need of public health fall prevention programs. The Tai Chi: Moving for Better Balance (MFBB) program is a community-based, fall-prevention exercise program for older adults. A waiver of informed consent will be requested to conduct the telephone screenings to determine study eligibility. We will enroll up to 300 people in classes to be held at 20 churches in West Virginia. Classes will be held twice per week for 16 weeks and taught by certified MFBB instructors. Participants will be interviewed by telephone, have a brief physical function ability exam, and complete a questionnaire before starting the exercise class, at the end of the class, and 4 months later. The study is being conducted to answer the following questions: 1) What are the functional improvements of older adults who participate in a 16-week MFBB program; 2) What is the rate of falls for those adults; 3) What is the rate and severity of those fall-related injuries of the MFBB participants? The purpose of the study is to: 1) implement a 16-week intervention of MFBB with a 16-week follow-up, in older adults in churches in rural West Virginia; 2) describe functional and fall/injury outcomes. Ultimately, we will translate an efficacious and effective fall-prevention intervention into a new setting.
West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
Tai Chi: Moving for Better Balance exercise program
Other: Tai Chi: Moving for Better Balance
Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.
Also known as: Tai Chi, Exercise, Physical Activity
10-Meter Walk Test
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed
Time frame: 16 weeks
Number of fall-related injuries
Measure the number of reported fall-related injuries by study participants during the intervention and during the 16-week period after the intervention is complete.
Time frame: 32 weeks
Number of falls
Measure the number of reported falls by study participants during the intervention and during the 16-week period after the intervention is complete.
Time frame: 32 weeks
Four Square Test
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
Time frame: 16 weeks
Timed Up-And-Go Test
The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.
Time frame: 16 weeks
Champs Activity Questionnaire for Older Adults
The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.
Time frame: 16 weeks
SF-12
The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.
Time frame: 16 weeks
Falls Efficacy Scale
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.
Time frame: 16 weeks
Translation of MFBB in the churches with respect to its Reach
We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.
Time frame: 16 weeks
Translation of MFBB in the churches with respect to its Adoption
We will determine the proportion of invited churches that offer MFBB.
Time frame: 16 weeks
Translation of MFBB in the churches with respect to its Implementation
We will determine if MFBB was delivered as intended by its developer.
Time frame: 16 weeks
Translation of MFBB in the churches with respect to its Maintenance (churches)
We will determine the proportion of churches who continue MFBB at 32 weeks.
Time frame: 32 weeks
Translation of MFBB in the churches with respect to its Maintenance (participants)
We will determine the proportion of participants who continue MFBB at 32 weeks.
Time frame: 32 weeks
10-Meter Walk Test
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.
Time frame: 32 weeks
Four Square Test
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
Time frame: 32 weeks
Timed Up-And-Go Test
The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.
Time frame: 32 weeks
Champs Activity Questionnaire for Older Adults
The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.
Time frame: 32 weeks
SF-12
The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.
Time frame: 32 weeks
Falls Efficacy Scale
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.
Time frame: 32 weeks
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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West Virginia University