Elderly Falls Prevention With sLiFE Program in Primary Care

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Enrolling

Conditions: Elderly; Accidental Falls; Frailty; Activities, Motor

Treatments: Behavioral: Intervention Group; Behavioral: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05912088

GRS 2502/B/22

Details and patient eligibility

About

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.

Full 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 sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Enrollment: 650 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

The strength and balance activities of the sLiFE program will be carried out. Participants will be invited to participate in groups of about 14 people in Primary Care Heath Centers.

Treatment:

Behavioral: Intervention Group

Control Group

Placebo Comparator group

Description:

Participants will receive the usual health advice.

Treatment:

Behavioral: Control Group