Elderly Falls Prevention With sLiFE Program in Primary Care

Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Elderly; Accidental Falls; Activities, Motor
• Intervention / Treatment: Behavioral: Intervention Group; Behavioral: Control Group

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 Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emiliano Rodríguez-Sánchez, Dr; Phone Number: 923231859; Email: emiliano@usal.es
• Study Contact Backup: Name: Luis García-Ortiz, Dr; Phone Number: 635542886; Email: lgarciao@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Recruiting
    • Primary Care Research Unit of Salamanca (APISAL)
    • Contact: Ines Llamas, Dra; Phone Number: 54750 923 291100; Email: inesllamas@usal.es
    • Contact: Emiliano Rodriguez, Dr; Phone Number: 54750 923 291100; Email: Emiliano@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Behavioral: Intervention Group; Subjects will participate in groups of about 14 to implement the program.
Placebo Comparator: Control Group; Participants will receive the usual health advice.	Behavioral: Control Group; Subjects will receive the usual care advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health effects	It will be measured using the quality of life questionnaire EQ-5D	6 months
Incidence of falls	Number of falls in relation to the degree of physical activity.	6 months
Physical activity	It will be evaluated with a digital pedometer for 9 consecutive days	8 days
Physical activity	It will be evaluated with the Global Physical Activity Questionnaire	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Cognitive assessment	It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.	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	6 months
Adherence to exercise	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.	6 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Investigators: Study Chair: Luis García-Ortiz, Dr, Primary Health Care Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: GRS 2502/B/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No