Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches

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 Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Other: Tai Chi: Moving for Better Balance

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Cairo, West Virginia, United States, 26337
      • Hughes River Presbyterian Church
    • Ellenboro, West Virginia, United States, 26346
      • Wesley United Methodist Church
    • Gandeeville, West Virginia, United States, 25243
      • Harper Memorial Church
    • Grantsville, West Virginia, United States, 26147
      • First Baptist Church
    • Harrisville, West Virginia, United States, 26362
      • First Assembly of God
    • Petroleum, West Virginia, United States, 26161
      • Cisco Community Church
    • Spencer, West Virginia, United States, 25276
      • First Baptist Church
    • Spencer, West Virginia, United States, 25276
      • Memorial United Methodist Church
    • Spencer, West Virginia, United States, 25276
      • Spencer Presbyterian Church

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 55 years or older

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity intervention; Tai Chi: Moving for Better Balance exercise program	Other: Tai Chi: Moving for Better Balance; Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.; Other Names: Exercise; Tai Chi; Physical Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	32 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Four Square Test	Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.	16 weeks
Timed Up-And-Go Test	The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.	16 weeks
Champs Activity Questionnaire for Older Adults	The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.	16 weeks
SF-12	The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.	16 weeks
Falls Efficacy Scale	The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.	16 weeks
Translation of MFBB in the churches with respect to its Reach	We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.	16 weeks
Translation of MFBB in the churches with respect to its Adoption	We will determine the proportion of invited churches that offer MFBB.	16 weeks
Translation of MFBB in the churches with respect to its Implementation	We will determine if MFBB was delivered as intended by its developer.	16 weeks
Translation of MFBB in the churches with respect to its Maintenance (churches)	We will determine the proportion of churches who continue MFBB at 32 weeks.	32 weeks
Translation of MFBB in the churches with respect to its Maintenance (participants)	We will determine the proportion of participants who continue MFBB at 32 weeks.	32 weeks
10-Meter Walk Test	A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.	32 weeks
Four Square Test	Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.	32 weeks
Timed Up-And-Go Test	The Timed Up-And-Go Test will be used to assess functional mobility. A participant stands from a chair, walks three meters at a self-selected pace, turns, and returns to the chair to sit.	32 weeks
Champs Activity Questionnaire for Older Adults	The CHAMPS Activities Questionnaire for Older Adults will be administered by telephone interview by trained team members to assess the typical weekly frequency and duration of participation in 41 leisure and daily activities during the past month. The CHAMPS has shown superior reliability, validity, and responsiveness over other instruments in trials of fall-injury prevention programs.	32 weeks
SF-12	The SF-12 v2, which is recommended for inclusion in fall/injury prevention trials, will be used to determine physical and mental health-related quality of life.	32 weeks
Falls Efficacy Scale	The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.	32 weeks

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: Department of Health and Human Services; Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Balance; Older Adults; Tai Chi; Rural; Accidental Falls; Church; Moving for Better Balance; Congregational Intervention; West Virginia
• Other Study ID Numbers: 5 R49 CE002109-DLJ