Interventions to Prevent Falls. PRECAISAL Study

NCT ID: NCT05070533

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2023-05-28

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.

Conditions

Accidental Falls; Old Age; Debility; Activity, Motor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.).

Group Type: ACTIVE_COMPARATOR

Individual treatment

Intervention Type: BEHAVIORAL

Participants will receive 7 home visits to implement the program.

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.

Group Type: EXPERIMENTAL

Groupal treatment

Intervention Type: BEHAVIORAL

Subjects will participate in groups of about 8 - 12 to implement the program.

Interventions

Individual treatment

Participants will receive 7 home visits to implement the program.

Intervention Type: BEHAVIORAL

Groupal treatment

Subjects will participate in groups of about 8 - 12 to implement the program.

Intervention Type: BEHAVIORAL

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
• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis García-Ortiz

Role: STUDY_CHAIR

Primary Health Care Research Unit

Locations

Infosalud

Salamanca, , Spain

Countries

Spain

Other Identifiers

GRS 1985/B/19

Identifier Type: -

Identifier Source: org_study_id