Accidental Falls, Activity, Motor, Old Age; Debility
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 physical exercises carried out through group workshops or 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 LiFE program is no less effective than individual intervention in reducing the incidence of falls.
Interventions
BEHAVIORALIndividual treatment
Participants will receive 7 home visits to implement the program.
BEHAVIORALGroupal treatment
Subjects will participate in groups of about 8 - 12 to implement the program.
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
70 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of falls | 6 months | Number of falls in relation to the degree of physical activity |
| Physical activity | 9 days | It will be evaluated with a digital pedometer |
| Cost-effectiveness | 6 months | Evaluated by the incremental cost-effectiveness ratio |
| Health effects | 6 months | They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of falling | 6 months | 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. |
| Adherence to exercise | 6 months | 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. |
Countries
Spain
Outcome results
None listed