Accidental Falls, Activities, Motor, Elderly, Frailty
Conditions
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.
Interventions
BEHAVIORALIntervention Group
Subjects will participate in groups of about 14 to implement the program.
BEHAVIORALControl Group
Subjects will receive the usual care advice
Sponsors
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 8 days | It will be evaluated with a digital pedometer for 9 consecutive days |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
Spain
Contacts
Primary ContactEmiliano Rodríguez-Sánchez, Dr
Backup ContactLuis García-Ortiz, Dr
Outcome results
None listed