Interventions to Prevent Falls. PRECAISAL Study

Accidental Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05070533
• Other study ID #: GRS 1985/B/19
• Status: Withdrawn
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: May 28, 2023

Study information

• Verified date: June 2023
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 28, 2023
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Falls
• Activity, Motor
• Frailty
• Old Age; Debility

Intervention

Behavioral:
• Individual treatment
Participants will receive 7 home visits to implement the program.
• Groupal treatment
Subjects will participate in groups of about 8 - 12 to implement the program.

Locations

Country	Name	City	State
Spain	Infosalud	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

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