Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia

Accidental Falls Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714100
• Other study ID #: 3R49CE002109-05S1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lack reliable transportation

• Unable to speak English

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• Tai Ji Quan: Moving for Better Balance
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.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 16 weeks after start of intervention
Secondary	Gait Speed: 5-meter walk test	A self-selected walking speed will be used to measure gait speed.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	Physical Activity: National Health Interview Survey (NHIS)	2016 NHIS questions	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	Fall rates (falls/person-months)	Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.	Collected at baseline, at the end of the intervention (16 weeks), and 32 weeks after the start of the study
Secondary	Injury frequency	Participants will be given a monthly calendar with a pre-paid postage return envelope to record falls/injuries.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	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.	Collected at end of the intervention (16 weeks)
Secondary	Process outcomes	Exercise adherence and adverse events will be collected via attendance and injury forms	Collected at end of intervention (16 weeks)