Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Accidental Falls
- Sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Frailty
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Frailty
Time Frame: 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
Time Frame: 6 months
It will be measured using the quality of life questionnaire EQ-5D
Incidence of falls
Time Frame: 6 months
Number of falls in relation to the degree of physical activity.
Physical activity
Time Frame: 6 months
It will be evaluated with the Global Physical Activity Questionnaire
Secondary Outcomes
- Fear of falling(6 months)
- Adherence to exercise(6 months)
- Cognitive assessment(6 months)
- Motor function(6 months)