Interventions to Prevent Falls. PRECAISAL Study

NCT05070533 | Withdrawn

• 1 other identifier: GRS 1985/B/19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls; Old Age; Debility; Activity, Motor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Fear of falling

  6 months

• Adherence to exercise

  6 months

Study Arms (2)

Individual treatment

ACTIVE COMPARATOR

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

Groupal treatment

EXPERIMENTAL

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

Interventions

Individual treatment BEHAVIORAL

Participants will receive 7 home visits to implement the program.

Individual treatment

Groupal treatment BEHAVIORAL

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

Groupal treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion y Formacion en Ciencias de la Salud: lead

Study Sites (1)

Infosalud

Salamanca, 37005, Spain

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Luis García-Ortiz

  Primary Health Care Research Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: January 2, 2020
• Primary Completion: April 1, 2020
• Study Completion: May 28, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)