Accidental FallsNCT01961037
Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches
A study testing Tai Chi: Moving for Better Balance in people with Accidental Falls, run by West Virginia University at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Tai Chi: Moving for Better Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2014to Mar 2015
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 55 years or older
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Hughes River Presbyterian Church
Cairo, West Virginia, 26337
Wesley United Methodist Church
Ellenboro, West Virginia, 26346
Harper Memorial Church
Gandeeville, West Virginia, 25243
First Baptist Church
Grantsville, West Virginia, 26147
First Assembly of God
Harrisville, West Virginia, 26362
Cisco Community Church
Petroleum, West Virginia, 26161
First Baptist Church
Spencer, West Virginia, 25276
Memorial United Methodist Church
Spencer, West Virginia, 25276
Spencer Presbyterian Church
Spencer, West Virginia, 25276
About this study
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.
- Conditions
- Accidental Falls
- Being tested
- Tai Chi: Moving for Better Balance
- Keywords
- Accidental Falls, Tai Chi, Older Adults, Balance, Moving for Better Balance, Church, Congregational Intervention, Rural, West Virginia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi: Moving for Better BalanceOther
Also called Tai Chi, Exercise, Physical Activity
Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Tai Chi: Moving for Better Balance exercise program Receives: Other: Tai Chi: Moving for Better Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed
Measured: 16 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Dina L Jones, PT, PhD, West Virginia University
- Investigators
- Dina L Jones, PT, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961037
- Sponsor's protocol ID
- 5 R49 CE002109-DLJ
- Other IDs
- 5R49CE002109
- Status last verified
- Dec 2015
- First submitted
- 11 Sep 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches
- ClinicalTrials.gov ID
- NCT01961037
- Acronym / sponsor ID
- 5 R49 CE002109-DLJ
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Tai Chi, Older Adults, Balance, Moving for Better Balance, Church, Congregational Intervention, Rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Centers for Disease Control and Prevention
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Oct 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Other: Tai Chi: Moving for Better BalanceTai Chi: Moving for Better Balance exercise program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 55 years or older
Key exclusion criteria (1 listed)
- None
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: Moving for Better BalanceAlso: Tai Chi, Exercise, Physical ActivityParticipants will attend one-hour Tai Chi classes twice weekly for 16 weeks. | Other | Physical activity intervention |
Primary outcome
10-Meter Walk Test
Time frame: 16 weeks
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed
2 secondary outcomes
Number of fall-related injuries
Time frame: 32 weeks
Number of falls
Time frame: 32 weeks
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 24 Dec 2015.
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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.
Dina L Jones, PT, PhD principal investigator
West Virginia University
9 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: Moving for Better Balance in people with Accidental Falls, run by West Virginia University at 9 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 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
10-Meter Walk Test (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2015.