Accidental FallsPhase 1/2NCT00714051
Fall Prevention Program for Older Adults
A Phase 1/2 study testing fall prevention training in people with Accidental Falls, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Accidental Falls
- What is being tested?
- fall prevention training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65-80 yr old,
- normal reflexes and muscle tone
Who cannot join
- lower extremity fracture or surgery last 5 yrs
- back surgery or disc herniation last 5 yrs
- noticeable gait impairment,
- low back pain,
- decreased disease-related vision,
- dizziness,
Show all 9Show fewer
- history of heart problems,
- bone mineral density <.65,
- mini-mental score <24
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
About this study
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.
Read the detailed description
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.
- Conditions
- Accidental Falls
- Being tested
- fall prevention training, Attention Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall prevention trainingBehavioural
Training on a specialized treadmill that produced trip-simulating perturbations (movements.
Attention ControlBehavioural
Participants walked on a treadmill at a self-selected speed once per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fall Prevention Training | Experimental | The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased. Receives: Behavioral: fall prevention training |
| Attention Control | Active comparator | The attention control group participated in four weekly treadmill walking sessions at a self-selected speed. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Fell on a Tripping Test
Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Accidental FallsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Illinois at Chicago
- Responsible party
- Sponsor
- Investigators
- Eileen G. Collins, PhD RN, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714051
- Sponsor's protocol ID
- E4955-R
- Status last verified
- Oct 2014
- First submitted
- 8 Jul 2008
- Last updated
- 8 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention Program for Older Adults
- ClinicalTrials.gov ID
- NCT00714051
- Acronym / sponsor ID
- E4955-R
- Conditions
- Accidental Falls
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Illinois at Chicago
- Study start
- Oct 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 8 Oct 2014
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 test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.
Detailed description
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fall Prevention Training | Experimental | Behavioral: fall prevention trainingThe falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe attention control group participated in four weekly treadmill walking sessions at a self-selected speed. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65-80 yr old,
- normal reflexes and muscle tone
Key exclusion criteria (9 listed)
- lower extremity fracture or surgery last 5 yrs
- back surgery or disc herniation last 5 yrs
- noticeable gait impairment,
- low back pain,
- decreased disease-related vision,
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 |
|---|---|---|
| fall prevention trainingTraining on a specialized treadmill that produced trip-simulating perturbations (movements. | Behavioural | Fall Prevention Training |
| Attention ControlParticipants walked on a treadmill at a self-selected speed once per week for four weeks. | Behavioural | Attention Control |
Primary outcome
Number of Participants Who Fell on a Tripping Test
Time frame: 4 weeks
Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
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Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
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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.
Eileen G. Collins, PhD RN principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fall prevention training in people with Accidental Falls, run by US Department of Veterans Affairs at 1 site 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 2 inclusion and 9 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Fell on a Tripping Test (time frame: 4 weeks). 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 8 Oct 2014; AzTrials last refreshed its copy on 27 Oct 2026.