Elderly Falls Prevention With sLiFE Program in Primary Care

Not Applicable

Recruiting

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

• Registration Number: NCT05912088
• 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 daily activities carried out through group workshops (guided by a physiotherapist) and 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 sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-11
• Study First Posted: 2023-06-22
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frailty	6 months	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.
Health effects	6 months	It will be measured using the quality of life questionnaire EQ-5D
Physical activity	6 months	It will be evaluated with the Global Physical Activity Questionnaire
Incidence of falls	6 months	Number of falls in relation to the degree of physical activity.

Secondary Outcome Measures

Name	Time	Method
Fear of falling	6 months	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.
Adherence to exercise	6 months	It will be assessed using the Exercise Adherence Rating Scale (EARS). It is composed of 16 items scored using a 5-point Likert scale (0 = completely agree to 4 = completely disagree) with a possible summed score range from 0 to 64.
Cognitive assessment	6 months	It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.
Motor function	6 months	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

Trial Locations

Locations (1)

Primary Care Research Unit of Salamanca (APISAL); 🇪🇸 Salamanca, Spain