Interventions to Prevent Falls. PRECAISAL Study

Study Overview
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Brief Summary
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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 physical exercises carried out through group workshops or at preventing risk situations at home.

Detailed Description
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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 LiFE program is no less effective than individual intervention in reducing the incidence of falls.

Official Title
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Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study

Conditions
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Accidental Falls, Old Age; Debility, Activity, Motor

Intervention / Treatment
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* Behavioral: Individual treatment
* Behavioral: Groupal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 70 years Live at your address Are at risk of falls Timed Up and Go Test time timed ≥ 12 seconds Able to walk 200 meters without personal assistance Speak and read in Spanish Exclusion Criteria: Perform moderate to vigorous physical activity> 150 min / week in the last 3 months Present any of the following medical conditions: Heart failure (New York Heart Association class III and IV) Recent stroke (<6 months) Parkinson's disease In active cancer treatment (last 6 months) Class III and IV chronic obstructive pulmonary disease Unstable fracture of the lower limb Lower limb amputated Treatment for less than 6 months of depression Uncontrolled resting blood pressure of a systolic pressure> 160 or a diastolic pressure> 100 or more Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of 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 scientific intervention trial.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual treatment<br>The strength and balance activities of the LiFE program will be carried out. Participants will receive 7 home visits and will be given the support material for the manual (diptychs, pictures, etc.). | Behavioral: Individual treatment<br>* Participants will receive 7 home visits to implement the program.<br>|
| Experimental: Groupal treatment<br>The strength and balance activities of the LiFE program will be carried out. Participants will be invited to participate in groups of about 8 - 12 people in community venues. | Behavioral: Groupal treatment<br>* Subjects will participate in groups of about 8 - 12 to implement the program.<br>|

What is the study measuring?
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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 | 9 days | 
| Cost-effectiveness | Evaluated by the incremental cost-effectiveness ratio | 6 months | 
| Health effects | They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of falling | It will be assessed using the Short Falls International Scale of Efficacy. This scale 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 | 
| Adherence to exercise | It will be assessed using the Exercise Adherence Rating Scale (EARS). This scale is composed of 16 items and they were 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 |