Interventions to Prevent Falls. PRECAISAL Study

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Withdrawn

Conditions: Activity, Motor; Accidental Falls; Old Age; Debility

Treatments: Behavioral: Groupal treatment; Behavioral: Individual treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05070533

GRS 1985/B/19

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Individual treatment

Active Comparator group

Description:

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.).

Treatment:

Behavioral: Individual treatment

Groupal treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Groupal treatment