Clinical trial NCT00126152: Senior Falls Prevention Study
Official title: Targeted Injury Prevention Program: Preventing Falls Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls Among Older Adults
Keywords: Falls
Exercise
Fall Risk Factors
Older Adults
Lead sponsor: Washington State, Department of Health
Sponsor class: OTHER_GOV
Collaborators: name: NorthWest Orthopaedic Institute
name: Spokane Regional Health District
name: University of Washington
name: Senior Services of Seattle/King County
First posted: 2005-08-02
Enrollment: 453
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of a best practice model for senior falls prevention when implemented in a community setting.

Detailed description: This study will measure differences in the incidence of falls and fall risk factors among subjects assigned to an intervention group and a control group. Subjects in the intervention group will receive a multi-faceted intervention based on best practices. Subjects in the control group will receive written fall prevention education materials. Fall monitoring will be conducted for subjects in both groups.

Specific components of the intervention will include:

* an individual fall risk assessment;
* exercise with balance and strength training;
* education on how to reduce falls and fall risk factors; and
* recommendations for medical care management of identified fall risk factors.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older;
* Live in the community in a house, apartment, or retirement center;
* Able to speak and understand English;
* Able to walk without the physical assistance of another person (using an assistive device, such as a cane or walker, is ok);
* Able to participate in a falls prevention program for 12 months;
* Able to participate in exercise classes that meet 3 times per week for a minimum of 6 months.
* Able to provide their own transportation and be a year-round resident;
* Have a health care provider that they had seen within the past three years;
* Able to see and hear another person from a distance of 10 to 12 feet.
* Able to complete a 10-foot Timed Up and Go Test in \< 30 seconds.
* Able to complete the Pfeiffer Short Portable Mental Status Questionnaire with fewer than 5 errors.

Exclusion Criteria:

* Participated in regular, moderate exercise during the past 3 months (Regular exercise means physical activity that is done 30 minutes or longer, 3 or more times a week. Moderate exercise includes any physical activity that makes the heart beat faster or makes a person breathe harder or sweat, such as brisk walking, active gardening, or climbing stairs.)
* Has Parkinson disease or multiple sclerosis;
* Is under doctor's orders to restrict activity level.

Primary outcomes:
measure: Change in the incidence of falls, reported once a month over a one year follow-up period.
Secondary outcomes:
measure: Changes in lower body strength, balance and mobility measured at baseline and repeated at the end of a one year follow-up period.
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Regional Health District
state: Washington
city: Tacoma
country: United States
facility: Northwest Orthopaedic Institute
state: Washington
Study officials:
affiliation: Washingon State Department of Health, Injury & Violence Prevention Program
name: Mary K LeMier, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State Department of Health, Injury & Violence Prevention Program
name: Ilene F Silver, MPH
role: PRINCIPAL_INVESTIGATOR
References: