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Completed

NCT Number: NCT01961037

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.

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Key information

Conditions

Accidental Falls

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hughes River Presbyterian Church, Cairo, West Virginia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 55 years or older

Exclusion criteria

  • None

Treatment and study plan

Tai Chi: Moving for Better Balance

Other

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

Other names: Tai Chi, Exercise, Physical Activity

Primary outcomes

  1. 10-Meter Walk Test

    Time frame: 16 weeks

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

Secondary outcomes

  1. Number of fall-related injuries

    Time frame: 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.

  2. Number of falls

    Time frame: 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 outcomes

  1. Four Square Test

    Time frame: 16 weeks

    Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.

  2. Timed Up-And-Go Test

    Time frame: 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.

  3. Champs Activity Questionnaire for Older Adults

    Time frame: 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.

  4. SF-12

    Time frame: 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.

  5. Falls Efficacy Scale

    Time frame: 16 weeks

    The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.

  6. Translation of MFBB in the churches with respect to its Reach

    Time frame: 16 weeks

    We will determine the proportion of eligible older adults who participate in a 16-week church-based intervention of MFBB.

  7. Translation of MFBB in the churches with respect to its Adoption

    Time frame: 16 weeks

    We will determine the proportion of invited churches that offer MFBB.

  8. Translation of MFBB in the churches with respect to its Implementation

    Time frame: 16 weeks

    We will determine if MFBB was delivered as intended by its developer.

  9. Translation of MFBB in the churches with respect to its Maintenance (churches)

    Time frame: 32 weeks

    We will determine the proportion of churches who continue MFBB at 32 weeks.

  10. Translation of MFBB in the churches with respect to its Maintenance (participants)

    Time frame: 32 weeks

    We will determine the proportion of participants who continue MFBB at 32 weeks.

  11. 10-Meter Walk Test

    Time frame: 32 weeks

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

  12. Four Square Test

    Time frame: 32 weeks

    Balance will be assessed using the Four Square Test which requires participants to step over low objects and move in four directions.

  13. Timed Up-And-Go Test

    Time frame: 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.

  14. Champs Activity Questionnaire for Older Adults

    Time frame: 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.

  15. SF-12

    Time frame: 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.

  16. Falls Efficacy Scale

    Time frame: 32 weeks

    The 10-item reliable and valid Falls Efficacy Scale will be utilized to assess fear of falling.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Department of Health and Human Services

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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