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Accidental FallsNCT02173015

Fall Recovery Training for Older Adults in Continuous Care Facilities

A study testing Compensatory step training in people with Accidental Falls, run by Mayo Clinic 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

The purpose of this study is to evaluate the effect that a new fall prevention training program has on the fall incidence of long-term care facility residents at high-risk of falling. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Accidental Falls
What is being tested?
Compensatory step training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Apr 2014to Dec 2016
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must be 50 years or older, living in continuous-care retirement facilities.

Who cannot join

  • For participation in study:
  • Three or more errors on the Six-Item Screener for Cognitive Impairment
  • Individuals who cannot provide consent for themselves
  • For participation in compensatory step training:
  • Physician or nurse practitioner approval to participate in the study with the guidelines that subjects should not participate if any of the following is applicable:
  • Unable to walk one block without stopping or using a walking aid (self-reported)
Show all 27Show fewer
  • Acute illness at the time of functional assessment or training
  • Body mass greater than 114 kg
  • Body size too large for wearing a safety harness
  • Lower extremity joint replacement within a year prior to participation
  • Femoral neck or total hip bone mineral density t-score less than -2.5
  • Based on a dual-energy X-ray absorptiometry (DXA) scan in the Mayo Clinic Charlton Clinical Research Unit (CRU), with no medication changes that may affect bone mineral density at the hip (e.g. starting prednisone). During the visit to the CRU, the subject's height and weight will be measured.
  • If the subject has had a hip DXA scan within 6 months of participation, the exclusion criterion will be based on the previous scan.
  • If the subject has had bilateral hip replacement, then the subject will not qualify for compensatory step training.
  • Dementia
  • Parkinson's disease
  • A history of stroke
  • A history of back surgery
  • Bulging vertebral discs
  • Spine, hip, or lower extremity fracture within a year prior to participation
  • Open lesions on the lower extremity
  • In case of lower extremity amputation, stump volume fluctuations within a year of training
  • Use of a pacemaker
  • Use of an ostomy pouch
  • Pregnancy
  • Doctor recommendation to avoid moderate physical activity or exercise
  • Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training, at the discretion of the clinician or study staff.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Compensatory Step Training for Reducing the Fall Incidence of Older Adults Residing in Continuous Care Facilities

The purpose of this study is to evaluate the effect that a new fall prevention training program has on the fall incidence of long-term care facility residents at high-risk of falling.

Read the detailed description

For Americans age 65 and older, falls are the leading cause of fatal and nonfatal unintentional injury. Although they only comprise about 5% of the elderly population, 20% of all fall-related elderly deaths are of continuous-care facility residents. In the five years after a fall, 75% of fallers in institutional care will die, while only 58% of age-matched non-fallers will die. The increased risk observed in such facilities is a product of a high fall incidence (26-56%) and fall rate (1.4-2.0 falls per person or bed). The incidence of recurrent falling in this population is about 33-40%, with 28% of fallers having five or more falls. Roughly 12-33% of falls result in serious injuries such as fracture, head trauma, soft-tissue injury, or severe lacerations. About 1-4% of falls result in fracture, an injury which comprises the majority (75%) of fall-related admissions from continuous-care facilities to hospitals. Such hospital admissions cost over $31,000 per admission, which contributes to an estimated medical cost of about $1,200 per fall. The proposed research is significant because it addresses the high incidence of fall-related injury and death, in turn reducing notable medical costs.

Based on a rigorous review of more than 1200 participants, supervised exercise has not significantly reduced the rate of falls (rate ratio: 0.74-1.35) or number of fallers (risk ratio: 0.88-1.21) in continuous-care facilities15. The most effective exercises focus on control of upright posture and the response to small gait disturbances (rate ratio: 0.24-0.85, risk ratio: 0.43-1.19). However, the efficacy of these interventions can be improved by safely increasing the magnitude of disturbances (i.e. greater intensity) and focusing on the skills necessary to recover from common fall causes (i.e. greater specificity). Compensatory step training safely induces a fall by delivering large postural disturbances, in turn requiring subjects to arrest a fall through timely, well-placed steps and reduced trunk rotation. Similar demands on step placement and trunk control are evident when recovering from a trip or slip, the most common fall-causes of older adults in the community. Obstacles and slippery surfaces are prevalent causes of falls within care facilities suggesting that trips and slips are also problematic in this environment. For community-dwelling older women, compensatory step training has significantly improved step and trunk kinematics and reduced falls due to trips in the laboratory (odds ratio = 0.13). Furthermore, preliminary evidence suggests that training reduces their fall incidence by 17% in the community. Published and unpublished data have shown that compensatory step training has improved the compensatory stepping response, undisturbed gait, and fall incidence of those with lower extremity amputations. It is likely that such training can benefit the high fall incidence observed in care facilities. The proposed research is innovative because it is a novel application of a state-of-the-art intervention that will likely improve the efficacy of supervised exercise as a means to reduce falls in continuous-care facilities.

A widely implemented prevention strategy in institutional settings is to target residents at high risk of falling. As assessed by subjective measures or fall history, the relative fall risk of high-risk residents is up to 3 times higher than that of low-risk residents. The fall incidence of low-risk residents, as determined by an objective functional test, has not been reported. Recording these statistics would provide perspective on this subpopulation relative to community-dwelling older adults, establishing a benchmark for evaluating the long-term effect of interventions for high-risk residents. Identifying the short-term, functional improvements associated with such interventions may reveal the mechanisms of training-based improvements, informing protocol development and improving its efficacy.

The primary objective is to evaluate the effect that compensatory step training has on the fall incidence of long-term care facility residents at high risk of falling. The investigators hypothesize that compensatory step training will prospectively reduce the fall incidence of high-risk residents to a level not inferior to the fall incidence of low-risk residents.

The study is a non-inferiority trial intended to show that the training of high-risk residents yields a fall incidence not worse than that of low-risk residents. Although such trials are less credible than other designs, the study demands fewer resources.

Functional assessments of fall risk will occur at the care facility. These assessments include the functional reach test, unipedal stance test, tandem stance test, figure-eight walking test, time-up-and-go test, step-up test, Activities-specific Balance Confidence questionnaire, grip strength test, maximum voluntary step length test, and fall history assessment.

Based on the results of the functional reach test and unipedal stance test, subjects will be identified as low-risk (functional reach > 8" AND unipedal stance > 5 s) or high-risk (functional reach ≤ 8" OR unipedal stance ≤ 5 s). Those at low risk of falling and those at high risk of falling who do not qualify for training will have their falls recorded for one year. Those at high risk of falling who qualify for training will undergo compensatory step training, undergo a second set of functional assessments, and then have their falls recorded for one year.

For high-risk subjects, health screenings will be assessed by a medical physician or nurse practitioner. If the subject does not meet the exclusion criteria, then no training will take place and the subject will have their falls monitored for one year. For high-risk subjects who otherwise pass all exclusion criteria, hip bone mineral density will be assessed using DXA in the Mayo Clinic Charlton Clinical Research Unit. If the subject does not meet the bone mineral density exclusion criterion (femoral neck or total hip bone mineral density t-score less than -2.5), then no training will take place and the subject will have their falls monitored for one year. If a DXA scan is of poor quality (e.g. there is artifact from subject movements), it will be repeated. At most, two DXA scans will be taken for each subject.

Subjects will participate in compensatory step training for up to 6 sessions in 7 to 30 days. Each session is comprised of anterior and posterior step training on a microprocessor-controlled treadmill (ActiveStep®, Simbex, Lebanon, NH). Training consists of a progression of anterior or posterior treadmill belt movements applied as the subject is standing or walking. The training intensity (magnitude of disturbance delivered) is progressive and dependent on subject performance. Subjects will be instructed to respond with single or multiple steps in order to prevent a fall. All subjects will be outfitted with a safety harness to prevent injury. This training specifically focuses on aspects important to trip and slip recovery. Up to 72 disturbances will be delivered each session.

Falls will be recorded for one year as per facility operations and with fall-tracking questionnaires.

Adults 50 years or older living in continuous-care retirement facilities will be recruited for this study. The investigators anticipate that 150 subjects will participate in the study, with 30 of those subjects participating in the compensatory step training.

Being tested
Compensatory step training
Keywords
accidental falls, older adults, long-term care, nursing home, postural balance

What participants receive

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

  • Compensatory step trainingOther

    The training consists of a progression of anterior or posterior treadmill belt movements applied as the subject is standing or walking. This training specifically focuses on aspects important to trip and slip recovery. Subjects will participate in up to 6 sessions in 7 to 30 days. The training intensity (magnitude of disturbance delivered) is progressive and dependent on subject performance. Subjects will be instructed to respond with single or multiple steps in order to prevent a fall. All subjects will be outfitted with a safety harness to prevent injury. Up to 72 disturbances will be delivered each session.

Study groups in NCT02173015
Study groupRoleWhat they receive
Low Fall RiskNo interventionIndividuals who have a functional reach greater than 8" and a unipedal stance time greater than 5 s.
High Fall Risk, No TrainingNo interventionIndividuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, but do not qualify for compensatory step training due to health concerns.
High Fall Risk, TrainingExperimentalIndividuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, and qualify for compensatory step training.
Receives: Other: Compensatory step training

What is being measured

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

  1. Fall Incidence

    The fall incidence (fallers / total group size) of low-risk residents, high-risk residents who do not complete training, and high-risk residents who complete training.

    Measured: up to 6 months

Timeline

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

  1. First posted24 Jun 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionOct 2016
  4. Study completionDec 2016

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173015
Sponsor's protocol ID
13-000605
Other IDs
UL1TR000135
Status last verified
Apr 2017
First submitted
1 May 2014
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Compensatory step training in people with Accidental Falls, run by Mayo Clinic 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 1 inclusion and 27 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 4 Apr 2017. 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?

Fall Incidence (time frame: up to 6 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 4 Apr 2017.

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