Interventions to Prevent Falls. PRECAISAL Study

Not Applicable

Withdrawn

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

• Registration Number: NCT05070533
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Study Timeline

• Study Start: 2020-01-02
• Primary Completion: 2020-04-01
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Study Completion: 2023-05-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Incidence of falls	6 months	Number of falls in relation to the degree of physical activity

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Infosalud; 🇪🇸 Salamanca, Spain