Interventions to Prevent Falls. PRECAISAL Study

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Accidental Falls Old Age; Debility Activity, Motor

Interventions

Individual treatmentBEHAVIORAL

Participants will receive 7 home visits to implement the program.

Groupal treatmentBEHAVIORAL

Subjects will participate in groups of about 8 - 12 to implement the program.

Eligibility

Sex: ALLMin age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Infosalud

Salamanca, Spain

Outcomes

Primary Outcomes

Incidence of falls

Number of falls in relation to the degree of physical activity

Time frame: 6 months

Physical activity

It will be evaluated with a digital pedometer

Time frame: 9 days

Cost-effectiveness

Evaluated by the incremental cost-effectiveness ratio

Time frame: 6 months

Health effects

They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5

Time frame: 6 months

Secondary Outcomes

Fear of falling

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.

Time frame: 6 months

Adherence to exercise

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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