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Accidental FallNCT02995486

Effects of a Falls Prevention Program Following Hospital Discharge

A study testing Exercise in people with Accidental Fall, run by Florida International University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, control trial will be conducted to evaluate the effects of a post-discharge falls prevention program in patients with neurological diseases and disorders. The objective of this study is to evaluate if implementing a falls prevention program is effective in reducing subsequent falls and… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Accidental Fall
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Nov 2016to Jan 2020
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Discharged from the hospital after being treated for a fall-related injury;
  • Able to engage in an exercise program for falls prevention (sufficient physical and cognitive health);
  • Competent to provide consent.

Who cannot join

  • Wheelchair bound;
  • Has contraindications for engaging in an exercise program based on the patient records;
  • Does not pass the Mini Cog test (brief cognitive screening tool)
  • Does not have reliable transportation for follow-up visits.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baptist Hospital

    Miami, Florida, 33176

Other trials in United States

About this study

Official title: Effects of a Falls Prevention Program Following Hospital Discharge From a Neuroscience Unit

A randomized, control trial will be conducted to evaluate the effects of a post-discharge falls prevention program in patients with neurological diseases and disorders. The objective of this study is to evaluate if implementing a falls prevention program is effective in reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center will be randomized on the day of discharge to receive an exercise falls prevention program, delivered by Baptist Health physical therapists, or an educational pamphlet on falls prevention. Baseline and follow up assessments for gait, balance, and strength will be completed at regular intervals to examine effects of the exercise program. In addition, participants will be surveyed to find out about recent falls and hospitalizations. This is a minimal risk study such that the assessments involve conditions in which subjects likely encounter on a daily basis. The risks of the exercise intervention also are no more than one might expect from a community exercise program. Potential benefits include reduced hospitalizations and/or emergency visits related to falls in the intervention group, increased activity levels and improved falls efficacy in the intervention group, and increased system capacity at Baptist Health to deliver a falls prevention program.

Read the detailed description

After signing the consent form, eligible participants will complete a health-related questionnaire and undergo a gait, balance and strength testing at the time of discharge and then be randomly referred to an intervention (n=30) or to a control group (n=30). Participants will be recruited until the target sample (n=60) is reached. Randomization will be by coin flip.

Measures (intervention and control groups): The evaluation involves non-invasive assessments of physical functioning conducted by physical therapists including balance, gait, and lower limb strength testing. Both groups will be tested by physical therapists at baseline 3, and 6 months post-discharge. A 12-month follow-up call will be made to all participants to ask about falls and physical activity. The physical therapists that conduct the testing will be different from the physical therapists that deliver the intervention (Otago Exercise Program). All tests will be completed in 60-90 minute sessions at Baptist Outpatient Rehabilitation Center. The participants will complete a questionnaire including information on health and falls history, falls self-efficacy (Falls Efficacy Scale), hospitalizations, doctors' visits, and emergency department visits. The participants will also complete a physical assessment including gait analysis using an instrumented mat (GaitRite) to collect data on the temporo-spatial parameters of gait during preferred gait speed and gait during street crossing simulation with regular time: 7 seconds. Street crossing regular time allowance was calculated based on the pre-programmed pedestrian street signals, which give pedestrians 20 seconds to cross a four-lane street. The GaitRite is a thin mat with pressure sensors; an integrated software and web-cam that measures and calculates the gait temporo-spatial parameters. The videos are used only as a visual reference to inspect the task for quality control during data collection and review and will not be used in the analysis or in any other way. The physical assessment will also include the BalanceMaster (Natus Medical, Inc.), a fixed force plate to measure the vertical forces exerted through the feet to measure center of gravity position and postural control, Tinneti Balance Assessment, lower limb strength testing using the 30-second chair stand test, and the Timed Up and Go (TUG) assessment for mobility testing.

Procedures (intervention and control groups): The participants will complete the gait, balance and chair-rise tests in random order. They will be asked a priori to wear non-slip socks provided by the research team. During the preferred gait speed condition, the participants will be instructed to walk on the GAITRite® at their preferred speed as they usually do during their daily activities. During the simulated street crossing condition, the participants will be instructed to cross the street when the pedestrian lights turn green and complete the crossing within the time allowed as displayed by the pedestrian lights on the video. The video includes audio of traffic noise for a more realistic road crossing environment, and it displays an intersection situation in which the subject will be positioned at the intersection, on the sidewalk looking at the oncoming motor vehicle traffic from both directions. A pedestrian light with countdown will also be displayed on the screen. Thus, a functional dual-task paradigm will be used including visual cues and the participants will have to interpret those cues and adjust their gait accordingly. A familiarization trial will be completed, followed by three recording trials under each condition. The order of gait conditions will be randomized for each participant. Participants are free to stop participating at anytime without needing to provide a reason.

Exercise Intervention (intervention group only): The intervention is a comprehensive program addressing aging-related functional decline, fear of falling and inactivity. It targets adults with a history of falls or at-risk for falls. Following the assessments, the participants will be assigned to a control group who will receive the standard educational information on falls prevention, or to an individualized exercise program prescribed and delivered by physical therapists (Otago Exercise Program for Falls Prevention). The program is an easy-to-implement and affordable exercise program for individuals with high risk for falls. The program design model is person-centered and customized to the individual needs. It includes a set of leg muscle strengthening and balance retraining exercises, and a walking plan. Subjects will go to Baptist Outpatient Rehabilitation Center before discharge for the baseline assessment and exercise prescription, then biweekly during the first 2 months (4 times) for exercise progressions and follow ups, once at month 3 for the first re-assessment, then again at 6 months for a booster session and second re-assessment. At 12 months a phone call follow up will be done to ask about falls and physical activity. The assessments and sessions will be covered by the Baptist Health Neuroscience Center and Rehabilitation Services. As part of the program, the participants will do 30 minutes of exercise three times per week, and walk continuously or not for 30 minutes at least two times per week for six months. Participants record (physical activity log) the days they exercise and walk and provide the information to the physical therapists during subsequent visits and/or calls.

Physical therapists will prescribe the exercises based on a large selection available on the program manual. The participants receive an illustration with explanations of the exercises they need to do. They receive a booklet with exercise instructions and ankle cuff weights. The physical therapists will do exercise progressions by increasing intensity and/or difficulty during the subsequent client visits to Baptist Outpatient Rehabilitation Center. The program also includes monthly telephone calls from study staff to maintain motivation, collect information on any falls, and answer questions between visits.

Conditions
Accidental Fall
Being tested
Exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Otago Exercise Program for falls prevention after discharge due to fall-related injuries.

Study groups in NCT02995486
Study groupRoleWhat they receive
ControlNo interventionStandard care with only an educational pamphlet.
InterventionExperimentalPost-discharge exercise group
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported subsequent falls

    Measured: 12 months

Secondary outcomes (13)
  1. Number of re-hospitalizations

    Measured: 12 months

  2. Gait velocity in cm/s from a GaitRite instrumented mat

    Measured: 12 months

  3. Grip strength in N using a Jamar

    Measured: 12 months

  4. Tinneti Balance Assessment scores

    Measured: 12 months

  5. Falls Efficacy Scale scores

    Measured: 12 months

  6. Velocity of center of pressure osculation on the balance master

    Measured: 12 months

  7. Dorsiflexion strength in N using a hand held dynamometer

    Measured: 12 months

  8. Step length in cm from a GaitRite instrumented mat

    Measured: 12 months

  9. Cadence in steps/minute from a GaitRite instrumented mat

    Measured: 12 months

  10. Step time in seconds from a GaitRite instrumented mat

    Measured: 12 months

  11. Swing time in seconds from a GaitRite instrumented mat

    Measured: 12 months

  12. Stance time in seconds from a GaitRite instrumented mat

    Measured: 12 months

  13. Double-support time in seconds from a GaitRite instrumented mat

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJan 2020
  4. Study completionJan 2020

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995486
Sponsor's protocol ID
IRB-15-0442
Status last verified
Jan 2020
First submitted
1 Dec 2016
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Accidental Fall, run by Florida International University 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 3 inclusion and 4 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 27 Jan 2020. 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.

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?

Self-reported subsequent falls (time frame: 12 months). 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 27 Jan 2020.

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