NCT03714100

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 11, 2018

Last Update Submit

October 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Gait Speed: 5-meter walk test

    Collected at end of the intervention (16 weeks)

  • Mobility: Timed up-and-go test

    Collected at end of the intervention (16 weeks)

  • Lower extremity strength: 5-chair stands test

    Collected at end of the intervention (16 weeks)

  • Physical Activity: National Health Interview Survey (NHIS)

    Collected at end of the intervention (16 weeks)

  • Health-related quality of life: Short Form-12 (SF-12)

    Collected at end of the intervention (16 weeks)

  • +7 more secondary outcomes

Study Arms (1)

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.

Behavioral: Tai Ji Quan: Moving for Better Balance

Interventions

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.

Also known as: Tai Chi, Physical Activity, Exercise
MFBB intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lack reliable transportation
  • Unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Interventions

Tai JiExercise

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dina L Jones, PT, PhD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 22, 2018

Study Start

November 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations