NCT01961037

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

9 active sites

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

September 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

September 11, 2013

Last Update Submit

December 22, 2015

Conditions

Accidental Falls

Keywords

Accidental FallsTai ChiOlder AdultsBalanceMoving for Better BalanceChurchCongregational InterventionRuralWest Virginia

Outcome Measures

Primary Outcomes (1)

  • 10-Meter Walk Test

    A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed

    16 weeks

Secondary Outcomes (2)

  • Number of fall-related injuries

    32 weeks

  • Number of falls

    32 weeks

Other Outcomes (16)

  • Four Square Test

    16 weeks

  • Timed Up-And-Go Test

    16 weeks

  • Champs Activity Questionnaire for Older Adults

    16 weeks

  • +13 more other outcomes

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

Tai Chi: Moving for Better Balance exercise program

Other: Tai Chi: Moving for Better Balance

Interventions

Tai Chi: Moving for Better BalanceOTHER

Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.

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

Eligibility Criteria

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

You may qualify if:

  • Aged 55 years or older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hughes River Presbyterian Church

Cairo, West Virginia, 26337, United States

Location

Wesley United Methodist Church

Ellenboro, West Virginia, 26346, United States

Location

Harper Memorial Church

Gandeeville, West Virginia, 25243, United States

Location

First Baptist Church

Grantsville, West Virginia, 26147, United States

Location

First Assembly of God

Harrisville, West Virginia, 26362, United States

Location

Cisco Community Church

Petroleum, West Virginia, 26161, United States

Location

First Baptist Church

Spencer, West Virginia, 25276, United States

Location

Memorial United Methodist Church

Spencer, West Virginia, 25276, United States

Location

Spencer Presbyterian Church

Spencer, West Virginia, 25276, 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
Associate Professor

Study Record Dates

First Submitted

September 11, 2013

First Posted

October 11, 2013

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(9)