Aging, Fall, Parkinson Disease, Stroke
Conditions
Keywords
Accidental falls, Clinical trial, Aged, Parkinson's Disease, Stroke, Exercise, Education
Brief 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.
Detailed description
BACKGROUND: Current literature on fall prevention for community-dwelling elderly who are at risk of falling suggests that: 1) either single, multicomponent or multifactorial interventions are effective at preventing falls; 2) elderly at risk of falling with Parkinson's Disease (PD) and previous Stroke, although having an even greater risk of falling, are often excluded by these interventions; 3) often, present screening methods for risk of falling do not allow the early identification of subjects at risk before the first fall. AIMS * To compare the efficacy of an interdisciplinary multicomponent and personalized multifactorial intervention aiming at reducing falls in comparison to the usual care, in a sample of community dwelling elderly, with or without Parkinson's Disease and/or previous Stroke, within the context of an RCT. * To improve the accuracy of screening tests for risk of falling by using wearable inertial sensors. * To develop a reduced set of clinical and instrumental indicators, to be utilized as a quick and reliable screening tests in outpatients clinics. METHODS: multicenter, randomized controller trial, with blind assessments on pretest, postest and on one-year follow-up. POPULATION: community-dwelling elderly (aged ≥65 years) with age-related or neurological condition-related (Parkinson's Disease and/or Stroke) risk of falling. INTERVENTION: interdisciplinary multi-component (group-based exercise; home-based exercise; increasing knowledge/education; home safety interventions) and personalized multi-factorial interventions (assessment and treatment of individual fall risk factors) CONTROL: structured information about participant's own personal risk factors given to the family doctor. OUTCOMES: The primary endpoint is the fall rate at one year in both groups. The secondary endpoint is the fall risk at one year. EXPECTED RESULTS: in the intervention group, a significant reduction in the number of total fall is expected, together with decreases indicators of utilization of acute health services because of falls. At three months, it is expected a significant improvement of functioning (motor functions, activity and participation) and health quality indicators.
Interventions
BEHAVIORALInterdisciplinary multicomponent interventions
BEHAVIORALUsual care
standard care
Sponsors
Azienda Ospedaliero-Universitaria di Modena
Azienda USL Reggio Emilia - IRCCS
Azienda Unita' Sanitaria Locale Di Modena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Community-dwelling elderly (aged ≥65 years) 2. Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke. 3. Ability to walk 10 meters without assistance (walking aid permitted) 4. Informed consent to participation
Exclusion criteria
1. Whatever concurrent medical condition which may constitutes a contraindication to physical exercise 2. 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 3. Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids. 4. 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). 5. Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions. 6. Acute vertigo or dizziness lasting less than 3 months 7. Regular participation to other exercise program that it is likely to challenge balance, including physical therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fall rate at 12 months from enrolment | Months 1 - Months 12 | The primary endpoint will be the total number of falls (fall rate) occurred in each arm within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of falls associated to hospital admission at 12 months from enrolment | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Severity of the fall | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Mortality attributable to fall | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Risk of falling at 12 months from enrolment | Months 1 - Months 12 | This secondary endpoint will be calculated as the number of patients with at least one falls within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Total number of A&E accesses attributable to falls | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Risk of A&E access attributable to falls | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Length of stay as inpatient attributable to falls | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
| Fall-free interval time | Months 1 - Months 12 | This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls |
Countries
Italy
Outcome results
None listed