Elderly Falls Prevention With sLiFE Program in Primary Care

N/AUnknownNCT05912088

Fundacion para la Investigacion y Formacion en Ciencias de la Salud650 enrolled

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 daily activities carried out through group workshops (guided by a physiotherapist) and 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 sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

650

Conditions

Accidental Falls Frailty Elderly Activities, Motor

Interventions

Intervention GroupBEHAVIORAL

Subjects will participate in groups of about 14 to implement the program.

Control GroupBEHAVIORAL

Subjects will receive the usual care advice

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * People older than 65 years of age * Living at home * Speak and read Spanish Exclusion Criteria: * Heart failure (NYHA class III and IV) * Recent stroke (\<6 months) * Parkinson's disease * In active cancer treatment (last 6 months) * GOLD class III and IV chronic obstructive pulmonary disease * Unstable lower extremity fracture * Amputated lower extremity * Treatment less than 6 months of depression * Uncontrolled resting blood pressure of a systolic \> 160 or diastolic \> 100 or more * Unavailability for intervention, planned travel or relocation 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 interventional clinical trial

Locations (1)

Primary Care Research Unit of Salamanca (APISAL)

Salamanca, Spain

RECRUITING

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 for 9 consecutive days

Time frame: 8 days

Physical activity

It will be evaluated with the Global Physical Activity Questionnaire

Time frame: 6 months

Frailty

Frailty will be measured according to the five criteria of Fried's phenotype: 1) Low muscle strength; 2) Poor nutrition; 3) Poor endurance; 4) Slow walking and 5) Low physical activity.

Time frame: 6 months

Health effects

It will be measured using the quality of life questionnaire EQ-5D

Time frame: 6 months

Secondary Outcomes

Fear of falling

It will be assesses using the Short Falls International Scale of Efficacy (Short FES I). It 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

Cognitive assessment

It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.

Time frame: 6 months

Motor function

It will be evaluated with the Short Physical Performance Battery (SPPB). It assesses three aspects of mobility: balance, gait speed and strength of limbs or lower limbs to get up from a chair

Central Contacts

Emiliano Rodríguez-Sánchez, Dr

CONTACT

923231859 emiliano@usal.es

Luis García-Ortiz, Dr

CONTACT

635542886 lgarciao@usal.es

Data from ClinicalTrials.gov

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