Falls Among Older AdultsNCT00126152
Senior Falls Prevention Study
A study testing Exercise, education and medical management in people with Falls Among Older Adults, run by Washington State, Department of Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls Among Older Adults
- What is being tested?
- Exercise, education and medical management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 453 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Spokane Regional Health District
Spokane, Washington, 99201
Northwest Orthopaedic Institute
Tacoma, Washington, 98401
About this study
Official title: Targeted Injury Prevention Program: Preventing Falls Among Older Adults
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.
Read the 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.
- Conditions
- Falls Among Older Adults
- Being tested
- Exercise, education and medical management
- Keywords
- Falls, Exercise, Fall Risk Factors, Older Adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, education and medical managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of falls, reported once a month over a one year follow-up period.
Secondary outcomes (1)
Changes in lower body strength, balance and mobility measured at baseline and repeated at the end of a one year follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startSep 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls Among Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 453 participants
Sponsor and investigators
- Lead sponsor
- Washington State, Department of Health
- Sponsor type
- Other government
- Collaborators
- NorthWest Orthopaedic Institute, Spokane Regional Health District, University of Washington, Senior Services of Seattle/King County
- Investigators
- Mary K LeMier, MPH, Principal investigator, Washingon State Department of Health, Injury & Violence Prevention ProgramIlene F Silver, MPH, Principal investigator, Washington State Department of Health, Injury & Violence Prevention Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126152
- Sponsor's protocol ID
- U17/CCU022310
- Status last verified
- Jul 2005
- First submitted
- 29 Jul 2005
- Last updated
- 2 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Injury Prevention Program: Preventing Falls Among Older Adults
- ClinicalTrials.gov ID
- NCT00126152
- Acronym / sponsor ID
- U17/CCU022310
- Conditions
- Falls Among Older Adults
- Keywords
- Falls, Exercise, Fall Risk Factors, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants
- Lead sponsor
- Washington State, Department of HealthOther government
- Collaborators
- NorthWest Orthopaedic Institute, Spokane Regional Health District, University of Washington, Senior Services of Seattle/King County
- Study start
- Sep 2003
- Study completion
- May 2005
- First posted
- 2 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise, education and medical management | Behavioural | – |
Primary outcome
Change in the incidence of falls, reported once a month over a one year follow-up period.
1 secondary outcome
Changes in lower body strength, balance and mobility measured at baseline and repeated at the end of a one year follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2005.
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ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK AMONG OLDER ADULTS RECEIVING INSTITUTIONAL CARE
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary K LeMier, MPH principal investigator
Washingon State Department of Health, Injury & Violence Prevention Program
Ilene F Silver, MPH principal investigator
Washington State Department of Health, Injury & Violence Prevention Program
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, education and medical management in people with Falls Among Older Adults, run by Washington State, Department of Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of falls, reported once a month over a one year follow-up period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2005.