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

Sponsor

West Virginia University (Other)

Overall Status

Completed

CT.gov ID

NCT01961037

Collaborator

Department of Health and Human Services (U.S. Fed), Centers for Disease Control and Prevention (U.S. Fed)

236

Enrollment

Locations

Arm

12.9

Duration (Months)

26.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Accidental Falls	Other: Tai Chi: Moving for Better Balance	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

236 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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: Tai Chi Exercise Physical Activity

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:

Tai Chi

Exercise

Physical Activity

Outcome Measures

Primary Outcome Measures

10-Meter Walk Test [16 weeks]
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed

Secondary Outcome Measures

Number of fall-related injuries [32 weeks]
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.
Number of falls [32 weeks]
Measure the number of reported falls by study participants during the intervention and during the 16-week period after the intervention is complete.

Other Outcome Measures

Four Square Test [16 weeks]
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
Timed Up-And-Go Test [16 weeks]
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.
Champs Activity Questionnaire for Older Adults [16 weeks]
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.
SF-12 [16 weeks]
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.
Falls Efficacy Scale [16 weeks]
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.
Translation of MFBB in the churches with respect to its Reach [16 weeks]
We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.
Translation of MFBB in the churches with respect to its Adoption [16 weeks]
We will determine the proportion of invited churches that offer MFBB.
Translation of MFBB in the churches with respect to its Implementation [16 weeks]
We will determine if MFBB was delivered as intended by its developer.
Translation of MFBB in the churches with respect to its Maintenance (churches) [32 weeks]
We will determine the proportion of churches who continue MFBB at 32 weeks.
Translation of MFBB in the churches with respect to its Maintenance (participants) [32 weeks]
We will determine the proportion of participants who continue MFBB at 32 weeks.
10-Meter Walk Test [32 weeks]
A timed 10-Meter Walk Test at a self-selected walking speed will be used to determine gait speed.
Four Square Test [32 weeks]
Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.
Timed Up-And-Go Test [32 weeks]
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.
Champs Activity Questionnaire for Older Adults [32 weeks]
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.
SF-12 [32 weeks]
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.
Falls Efficacy Scale [32 weeks]
The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 55 years or older

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hughes River Presbyterian Church	Cairo	West Virginia	United States	26337
2	Wesley United Methodist Church	Ellenboro	West Virginia	United States	26346
3	Harper Memorial Church	Gandeeville	West Virginia	United States	25243
4	First Baptist Church	Grantsville	West Virginia	United States	26147
5	First Assembly of God	Harrisville	West Virginia	United States	26362
6	Cisco Community Church	Petroleum	West Virginia	United States	26161
7	First Baptist Church	Spencer	West Virginia	United States	25276
8	Memorial United Methodist Church	Spencer	West Virginia	United States	25276
9	Spencer Presbyterian Church	Spencer	West Virginia	United States	25276