Interventions to Prevent Falls. PRECAISAL Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Individual treatment 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
Participants will receive 7 home visits to implement the program.
|
| Experimental: Groupal treatment 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
Subjects will participate in groups of about 8 - 12 to implement the program.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Older than 70 years
-
Live at your address
-
Are at risk of falls
-
Timed Up and Go Test time timed ≥ 12 seconds
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Able to walk 200 meters without personal assistance
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Speak and read in Spanish
Exclusion Criteria:
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Perform moderate to vigorous physical activity> 150 min / week in the last 3 months
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Present any of the following medical conditions:
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Heart failure (New York Heart Association class III and IV)
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Recent stroke (<6 months)
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Parkinson's disease
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In active cancer treatment (last 6 months)
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Class III and IV chronic obstructive pulmonary disease
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Unstable fracture of the lower limb
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Lower limb amputated
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Treatment for less than 6 months of depression
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Uncontrolled resting blood pressure of a systolic pressure> 160 or a diastolic pressure> 100 or more
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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
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Moderate to severe cognitive impairment (Mini Mental cognitive assessment <23)
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Current participation in another scientific intervention trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Investigators
- Study Chair: Luis García-Ortiz, Primary Health Care Research Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GRS 1985/B/19