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Clinical Trials/NCT05070533
NCT05070533
Withdrawn
N/A

Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study

Fundacion para la Investigacion y Formacion en Ciencias de la Salud1 site in 1 countryJanuary 2, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Accidental Falls
Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Locations
1
Primary Endpoint
Physical activity
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
May 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Responsible Party
Sponsor

Eligibility 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
  • 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

Outcomes

Primary Outcomes

Physical activity

Time Frame: 9 days

It will be evaluated with a digital pedometer

Cost-effectiveness

Time Frame: 6 months

Evaluated by the incremental cost-effectiveness ratio

Health effects

Time Frame: 6 months

They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5

Incidence of falls

Time Frame: 6 months

Number of falls in relation to the degree of physical activity

Secondary Outcomes

  • Adherence to exercise(6 months)
  • Fear of falling(6 months)

Study Sites (1)

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