Elderly Falls Prevention With sLiFE Program in Primary Care

Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912088
Collaborator
(none)
650
2
25

Study Details

Study Description

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 daily activities carried out through group workshops (guided by a physiotherapist) and at preventing risk situations at home.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention Group
  • Behavioral: Control Group
N/A

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 sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

The strength and balance activities of the sLiFE program will be carried out. Participants will be invited to participate in groups of about 14 people in Primary Care Heath Centers.

Behavioral: Intervention Group
Subjects will participate in groups of about 14 to implement the program.

Placebo Comparator: Control Group

Participants will receive the usual health advice.

Behavioral: Control Group
Subjects will receive the usual care advice

Outcome Measures

Primary Outcome Measures

  1. Incidence of falls [6 months]

    Number of falls in relation to the degree of physical

  2. Physical activity [8 days]

    It will be evaluated with a digital pedometer

  3. Physical activity [6 months]

    It will be evaluated with the Global Physical Activity Questionnaire (GPAQ)

  4. Frailty [6 months]

    It will be evaluated with the Fried phenotype criteria

  5. Health effects [6 months]

    It will be measured using the quality of life questionnaire EQ-5D

Secondary Outcome Measures

  1. Fear of falling [6 months]

    It will be assesses using the Short Falls International Scale of Efficacy (Short FES I)

  2. Cognitive assessment [6 months]

    It will be evaluated with the Montreal Cognitive Assessment (MoCA)

  3. Motor function [6 months]

    It will be evaluated with the Short Physical Performance Battery (SPPB)

  4. Adherence to exercise [6 months]

    It will be assessed using the Exercise Adherence Rating Scale (EARS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • People older than 65 years of age

  • Living at home

  • Speak and read Spanish

Exclusion Criteria:
  • Heart failure (NYHA class III and IV)

  • Recent stroke (<6 months)

  • Parkinson's disease

  • In active cancer treatment (last 6 months)

  • GOLD class III and IV chronic obstructive pulmonary disease

  • Unstable lower extremity fracture

  • Amputated lower extremity

  • Treatment less than 6 months of depression

  • Uncontrolled resting blood pressure of a systolic > 160 or diastolic > 100 or more

  • Unavailability for intervention, planned travel or relocation 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 interventional clinical trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Chair: Luis GarcĂ­a-Ortiz, Dr, Primary Health Care Research Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT05912088
Other Study ID Numbers:
  • GRS 2502/B/22
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023