Interventions to Prevent Falls. PRECAISAL Study
- Conditions
- Activity, MotorOld Age; DebilityAccidental Falls
- Interventions
- Behavioral: Groupal treatmentBehavioral: Individual treatment
- 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- WITHDRAWN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
- Arm && Interventions
Group Intervention Description Groupal treatment Groupal treatment The strength and balance activities of the LiFE program will be carried out. Participants will be invited to participate in groups of about 8 - 12 people in community venues. Individual treatment Individual treatment The strength and balance activities of the LiFE program will be carried out. Participants will receive 7 home visits and will be given the support material for the manual (diptychs, pictures, etc.).
- 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