Elderly Falls Prevention With sLiFE Program in Primary Care

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912088
• Other study ID #: GRS 2502/B/22
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: Emiliano Rodríguez-Sánchez, Dr
• Phone: 923231859
• Email: emiliano[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: July 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls
• Activities, Motor
• Elderly
• Frailty

Intervention

Behavioral:
• Intervention Group
Subjects will participate in groups of about 14 to implement the program.
• Control Group
Subjects will receive the usual care advice

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Salamanca (APISAL)	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of falls	Number of falls in relation to the degree of physical activity.	6 months
Primary	Physical activity	It will be evaluated with a digital pedometer for 9 consecutive days	8 days
Primary	Physical activity	It will be evaluated with the Global Physical Activity Questionnaire	6 months
Primary	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
Primary	Health effects	It will be measured using the quality of life questionnaire EQ-5D	6 months
Secondary	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
Secondary	Cognitive assessment	It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.	6 months
Secondary	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
Secondary	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