CompletedNot Applicable

PRE.C.I.S.A - Fall Prevention and Promotion of Active and Healthy Aging

Italy366 participantsStarted 2014-12-31

Plain-language summary

Randomized Controlled Trial (RCT) aiming at assessing the efficacy of an interdisciplinary multi-component and personalized multi-factorial intervention for reducing falls at one year post-enrolment in comparison to the usual care in a sample of community dwelling elderly (age ≥65 years), with or without Parkinson's Disease and/or previous Stroke.

Who can participate

Age range65 Years

SexALL

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Inclusion criteria

✓. Community-dwelling elderly (aged ≥65 years)
✓. Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke.
✓. Ability to walk 10 meters without assistance (walking aid permitted)
✓. Informed consent to participation

Exclusion criteria

✕. Whatever concurrent medical condition which may constitutes a contraindication to physical exercise
✕. Known cognitive decline or an established diagnosis of dementia (mini mental score \>24) or an evident cognitive decline on pre-enrolment which would be likely to impair the ability of comprehension of simple instructions and / or of collaborating
✕. Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids.
✕. Severe hypovision, not counteracted by lenses, which will limit the patient in executing at least one activity of daily living (for instance, necessity of assistance for walking because of visual deficit).
✕. Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions.
✕. Acute vertigo or dizziness lasting less than 3 months
✕. Regular participation to other exercise program that it is likely to challenge balance, including physical therapy.

What they're measuring

Fall rate at 12 months from enrolment

Timeframe: Months 1 - Months 12

Trial details

NCT IDNCT03592420

SponsorAzienda Unita' Sanitaria Locale Di Modena

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-31

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