Elderly Falls Prevention With sLiFE Program in Primary Care
- Conditions
- Accidental FallsFrailtyElderlyActivities, Motor
- Interventions
- Behavioral: Control GroupBehavioral: Intervention Group
- Registration Number
- NCT05912088
- Lead Sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 650
- People older than 65 years of age
- Living at home
- Speak and read Spanish
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Control Group Participants will receive the usual health advice. Intervention Group 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.
- Primary Outcome Measures
Name Time Method Frailty 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 6 months It will be measured using the quality of life questionnaire EQ-5D
Incidence of falls 6 months Number of falls in relation to the degree of physical activity.
Physical activity 6 months It will be evaluated with the Global Physical Activity Questionnaire
- Secondary Outcome Measures
Name Time Method Fear of falling 6 months 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.
Adherence to exercise 6 months 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.
Cognitive assessment 6 months It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete.
Motor function 6 months 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
Trial Locations
- Locations (1)
Primary Care Research Unit of Salamanca (APISAL)
🇪🇸Salamanca, Spain