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Fall Recovery Training for Older Adults in Continuous Care Facilities

2 aprile 2017 aggiornato da: Kenton R. Kaufman, Ph.D., Mayo Clinic

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  1. For participation in study:

    • Three or more errors on the Six-Item Screener for Cognitive Impairment
    • Individuals who cannot provide consent for themselves
  2. 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)
    • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Low Fall Risk
Individuals who have a functional reach greater than 8" and a unipedal stance time greater than 5 s.
Nessun intervento: High Fall Risk, No Training
Individuals 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.
Sperimentale: High Fall Risk, Training
Individuals 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fall Incidence
Lasso di tempo: up to 6 months
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.
up to 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2014

Completamento primario (Effettivo)

1 ottobre 2016

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

1 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2014

Primo Inserito (Stima)

24 giugno 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 13-000605
  • UL1TR000135 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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