Status:
UNKNOWN
Combined Exercise and Cognitive Stimulation for Falls Prevention
Lead Sponsor:
Fundacion Miguel Servet
Conditions:
Fall
Frailty
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
Randomized clinical trial of 310 older adults over 75 years old recruited from the Falls Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San Sebastián, Albacete and ...
Detailed Description
Usual care: subjects randomized to the usual care group will receive an evidence-based multidisciplinary intervention tailored at reducing the fall risk (polypharmacy, environmental intervention, phys...
Eligibility Criteria
Inclusion
- Age ≥ 75 years or older
- Referral to the Falls Unit
- Ability to ambulate independently with or without technical aids
- Barthel Index ≥ 60
- Pre-frailty (1-2 criteria) or Frailty according to the Frailty Phenotype by Fried et al
- Risk of falling according to following criteria:
- Gait disorders captured through physical performance measures (Time Up and Go Test ≥ 20 s and/or Gait Speed ≥0,8 m/s
- ≥2 self-reported falls in the previous year
- ≥1 self-reported falls requiring medical assistance
- Relative/caregiver willingness to supervise the exercise/cognitive stimulation sessions
- Capability and willingness to provide informed consent
Exclusion
- Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group
- Life expectancy ≤ 3 months
- Terminal illness
- No possibility of follow-up
- Institutionalization or awaiting institutionalization
- Major cognitive impairment DSM-V moderate or severe (CDR 2-3 /GDS 5-7)
- No ability to read and write
- Severe visual and hearing deficit
- Any contraindications for physical exercise or testing procedures, including but not limited to:
- myocardial infarction in the past 3 months
- unstable angina pectoris
- uncontrolled arrhythmia
- unstable cardiovascular disease or other unstable medical condition
- uncontrolled arterial hypertension
- recent pulmonary thromboembolism
- upper or lower extremity fracture in the past 3 months
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04911179
Start Date
March 1 2021
End Date
April 1 2024
Last Update
June 2 2021
Active Locations (1)
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1
Complejo Hospitalario de Navarra. Department of Geriatrics
Pamplona, Navarre, Spain, 31008