Interventions to Prevent Falls. PRECAISAL Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Old Age; Debility; Accidental Falls; Activity, Motor
• Intervention / Treatment: Behavioral: Individual treatment; Behavioral: Groupal treatment

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Garcia-Ortiz; Phone Number: 635542886; Email: lgarciao@usal.es
• Study Contact Backup: Name: Emiliano Rodríguez-Sánchez; Phone Number: 923231859; Email: emiliano@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Infosalud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of falls	Number of falls in relation to the degree of physical activity	6 months
Physical activity	It will be evaluated with a digital pedometer	9 days
Cost-effectiveness	Evaluated by the incremental cost-effectiveness ratio	6 months
Health effects	They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling	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.	6 months
Adherence to exercise	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.	6 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Investigators: Study Chair: Luis García-Ortiz, Primary Health Care Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 28, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: GRS 1985/B/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No