Accidental FallsNCT03714100
Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia
A study testing Tai Ji Quan: Moving for Better Balance in people with Accidental Falls, run by West Virginia University at 1 site in United States.
Trial summary
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention… 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 Ji Quan: Moving for Better Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Jan 2020
- 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
- Adults age 55 and older
- Community-dwelling
- Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks
- Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week after the classes end)
- Able to walk at least 2 city blocks with or without an assistive device
Who cannot join
- Lack reliable transportation
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older Adults in West Virginia
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
Read the detailed description
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, CDC-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others. We recently completed a CDC-funded study which successfully translated a 16-week TJQMBB intervention into 20 faith-based organizations in 7 rural WV counties. In the maintenance phase of the study (i.e., post intervention), only 38% of classes continued despite the fact that 87% of participants expressed a desire to continue. The rate limiting factor for continuing classes in these rural areas was lack of instructors. Thus, there is a vital need to further translate TJQMBB into practice using alternative delivery channels to increase the reach and maintenance of the program, especially in rural areas where instructors are less available.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
The purpose of this translational study is to work with our injury control, technology, and wellness partners to: 1) implement a 16-week intervention of the tele-TJQMBB classes in 120 older adults at 12 community sites in 4 WV counties; 2) describe functional, self-reported, and fall/injury outcomes; and 3) evaluate the translation of tele-TJQMBB with respect to its Reach into the target population (number of participants), Effectiveness (participant outcomes), Adoption (number of sites, instructors, classes), Implementation (fidelity ratings), and Maintenance (satisfaction, continued participation) using the Re-aim Framework. Demonstrating that tele-TJQMBB is effective would provide an additional delivery channel for the program, help overcome the barrier of identifying instructors in rural areas, and in the future, allow for the number of classes to be expanded to reach more older adults, provide more community-based programs in which to refer older adults to, and enhance overall maintenance of the program. To our knowledge, this is the first study to translate an evidence-based, group, fall-prevention exercise program using an alternative delivery method in a priority population, and thus, may serve as a model for reaching other underserved older adults.
- Conditions
- Accidental Falls
- Being tested
- Tai Ji Quan: Moving for Better Balance
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
Also called Tai Chi, Physical Activity, Exercise
Participants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
| Study group | Role | What they receive |
|---|---|---|
| MFBB intervention | Experimental | All participants will attend Tai Ji Quan: Moving for Better Balance classes twice a week for 16 weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed. Receives: Behavioral: Tai Ji Quan: Moving for Better Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Test
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in 4 directions.
Measured: At 16 weeks after start of intervention
Secondary outcomes (12)
Gait Speed: 5-meter walk test
A self-selected walking speed will be used to measure gait speed.
Measured: Collected at end of the intervention (16 weeks)
Mobility: Timed up-and-go test
A participant stands from a chair, walks 3 meters at a self-selected pace, turns, and returns to the chair to sit.
Measured: Collected at end of the intervention (16 weeks)
Lower extremity strength: 5-chair stands test
A participant is times as they stand up from a seated position five times. The test ends when the participant achieves the standing position on the 5th repetition.
Measured: Collected at end of the intervention (16 weeks)
Physical Activity: National Health Interview Survey (NHIS)
2016 NHIS questions
Measured: Collected at end of the intervention (16 weeks)
Health-related quality of life: Short Form-12 (SF-12)
Questionnaire used to measure functional health and well-being from the participant's point of view.
Measured: Collected at end of the intervention (16 weeks)
Fear of falling: Falls Efficacy Scale
Tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
Measured: Collected at end of the intervention (16 weeks)
Fall frequency (falls, fallers, and frequent fallers)
Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
Measured: Collected at end of the intervention (16 weeks)
Fall rates (falls/person-months)
Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
Measured: Collected at baseline, at the end of the intervention (16 weeks), and 32 weeks after the start of the study
Injury frequency
Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.
Measured: Collected at end of the intervention (16 weeks)
Injury severity
If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
Measured: Collected at end of the intervention (16 weeks)
Medical care received
If an injury was reported on the falls calendar, we will conduct a telephone interview with the participant to obtain the mechanism of the fall, the type and severity of any injuries, and details about any medical care that was received.
Measured: Collected at end of the intervention (16 weeks)
Process outcomes
Exercise adherence and adverse events will be collected via attendance and injury forms
Measured: Collected at end of intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- 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
- NCT03714100
- Sponsor's protocol ID
- 3R49CE002109-05S1
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older Adults in West Virginia
- ClinicalTrials.gov ID
- NCT03714100
- Acronym / sponsor ID
- 3R49CE002109-05S1
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
Detailed description
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, CDC-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others. We recently completed a CDC-funded study which successfully translated a 16-week TJQMBB intervention into 20 faith-based organizations in 7 rural WV counties. In the maintenance phase of the study (i.e., post intervention), only 38% of classes continued despite the fact that 87% of participants expressed a desire to continue. The rate limiting factor for continuing classes in these rural areas was lack of instructors. Thus, there is a vital need to further translate TJQMBB into practice using alternative delivery channels to increase the reach and maintenance of the program, especially in rural areas where instructors are less available.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
The purpose of this translational study is to work with our injury control, technology, and wellness partners to: 1) implement a 16-week intervention of the tele-TJQMBB classes in 120 older adults at 12 community sites in 4 WV counties; 2) describe functional, self-reported, and fall/injury outcomes; and 3) evaluate the translation of tele-TJQMBB with respect to its Reach into the target population (number of participants), Effectiveness (participant outcomes), Adoption (number of sites, instructors, classes), Implementation (fidelity ratings), and Maintenance (satisfaction, continued participation) using the Re-aim Framework. Demonstrating that tele-TJQMBB is effective would provide an additional delivery channel for the program, help overcome the barrier of identifying instructors in rural areas, and in the future, allow for the number of classes to be expanded to reach more older adults, provide more community-based programs in which to refer older adults to, and enhance overall maintenance of the program. To our knowledge, this is the first study to translate an evidence-based, group, fall-prevention exercise program using an alternative delivery method in a priority population, and thus, may serve as a model for reaching other underserved older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFBB intervention | Experimental | Behavioral: Tai Ji Quan: Moving for Better BalanceAll participants will attend Tai Ji Quan: Moving for Better Balance classes twice a week for 16 weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 55 and older
- Community-dwelling
- Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks
- Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week after the classes end)
- Able to walk at least 2 city blocks with or without an assistive device
Key exclusion criteria (2 listed)
- Lack reliable transportation
- Unable to speak English
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 BalanceAlso: Tai Chi, Physical Activity, ExerciseParticipants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed. | Behavioural | MFBB intervention |
Primary outcome
Four Square Test
Time frame: At 16 weeks after start of intervention
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in 4 directions.
12 secondary outcomes
Gait Speed: 5-meter walk test
Time frame: Collected at end of the intervention (16 weeks)
Mobility: Timed up-and-go test
Time frame: Collected at end of the intervention (16 weeks)
Lower extremity strength: 5-chair stands test
Time frame: Collected at end of the intervention (16 weeks)
Physical Activity: National Health Interview Survey (NHIS)
Time frame: Collected at end of the intervention (16 weeks)
Health-related quality of life: Short Form-12 (SF-12)
Time frame: Collected at end of the intervention (16 weeks)
Fear of falling: Falls Efficacy Scale
Time frame: Collected at end of the intervention (16 weeks)
Fall frequency (falls, fallers, and frequent fallers)
Time frame: Collected at end of the intervention (16 weeks)
Fall rates (falls/person-months)
Time frame: Collected at baseline, at the end of the intervention (16 weeks), and 32 weeks after the start of the study
Injury frequency
Time frame: Collected at end of the intervention (16 weeks)
Injury severity
Time frame: Collected at end of the intervention (16 weeks)
Medical care received
Time frame: Collected at end of the intervention (16 weeks)
Process outcomes
Time frame: Collected at end of intervention (16 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 14 Oct 2020.
- Individual participant dataSharing planned: No
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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
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 in people with Accidental Falls, run by West Virginia University 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 5 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 14 Oct 2020. 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?
Four Square Test (time frame: At 16 weeks after start of intervention). 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 14 Oct 2020.