Elderly Falls Prevention With sLiFE Program in Primary Care

Study Overview
=================
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.

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

Conditions
-----------------
Accidental Falls, Frailty, Elderly, Activities, Motor

Intervention / Treatment
-----------------
* Behavioral: Intervention Group
* Behavioral: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Health effects | It will be measured using the quality of life questionnaire EQ-5D | 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 |