Interventions to Prevent Falls. PRECAISAL Study
- Conditions
- Activity, MotorOld Age; DebilityAccidental Falls
- Registration Number
- NCT05070533
- Lead Sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Brief Summary
This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.
- Detailed Description
Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.
The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Older than 70 years
- Live at your address
- Are at risk of falls
- Timed Up and Go Test time timed ≥ 12 seconds
- Able to walk 200 meters without personal assistance
- Speak and read in Spanish
-
Perform moderate to vigorous physical activity> 150 min / week in the last 3 months
-
Present any of the following medical conditions:
- Heart failure (New York Heart Association class III and IV)
- Recent stroke (<6 months)
- Parkinson's disease
- In active cancer treatment (last 6 months)
- Class III and IV chronic obstructive pulmonary disease
- Unstable fracture of the lower limb
- Lower limb amputated
- Treatment for less than 6 months of depression
- Uncontrolled resting blood pressure of a systolic pressure> 160 or a diastolic pressure> 100 or more
- Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study
- Moderate to severe cognitive impairment (Mini Mental cognitive assessment <23)
- Current participation in another scientific intervention trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Physical activity 9 days It will be evaluated with a digital pedometer
Cost-effectiveness 6 months Evaluated by the incremental cost-effectiveness ratio
Health effects 6 months They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5
Incidence of falls 6 months Number of falls in relation to the degree of physical activity
- Secondary Outcome Measures
Name Time Method Adherence to exercise 6 months It will be assessed using the Exercise Adherence Rating Scale (EARS). This scale is composed of 16 items and they were scored using a 5-point Likert scale (0 = completely agree to 4 = completely disagree) with a possible summed score range from 0 to 64.
Fear of falling 6 months It will be assessed using the Short Falls International Scale of Efficacy. This scale measures of "concerns about falling". This scale has 7 items with a Likert scale with 4 options: 1) not at all concerned, 2) somewhat concerned, 3) fairly concerned, and 4) very concerned.
Trial Locations
- Locations (1)
Infosalud
🇪🇸Salamanca, Spain
Infosalud🇪🇸Salamanca, Spain