NCT05912088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

June 11, 2023

Last Update Submit

October 16, 2023

Conditions

Accidental FallsFrailtyElderlyActivities, Motor

Outcome Measures

Primary Outcomes (5)

  • 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 for 9 consecutive days

    8 days

  • Physical activity

    It will be evaluated with the Global Physical Activity Questionnaire

    6 months

  • Frailty

    Frailty will be measured according to the five criteria of Fried's phenotype: 1) Low muscle strength; 2) Poor nutrition; 3) Poor endurance; 4) Slow walking and 5) Low physical activity.

    6 months

  • Health effects

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

    6 months

Secondary Outcomes (4)

  • Fear of falling

    6 months

  • Cognitive assessment

    6 months

  • Motor function

    6 months

  • Adherence to exercise

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Participants will receive the usual health advice.

Behavioral: Control Group

Interventions

Intervention GroupBEHAVIORAL

Subjects will participate in groups of about 14 to implement the program.

Intervention Group
Control GroupBEHAVIORAL

Subjects will receive the usual care advice

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • People older than 65 years of age
  • Living at home
  • Speak and read Spanish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit of Salamanca (APISAL)

Salamanca, 37005, Spain

RECRUITING

Related Publications (1)

  • Llamas-Ramos I, Llamas-Ramos R, Lugones-Sanchez C, Gonzalez-Garcia S, Tamayo-Morales O, Alvarado-Omenat JJ, Pablos-Hernandez C, Gomez-Marcos MA, Garcia-Ortiz L, Rodriguez-Sanchez E. Effect of a lifestyle-integrated functional exercise (LiFE) group intervention (sLiFE) to falls prevention in non-institutionalized older adults. Protocol of a randomised clinical trial. Front Public Health. 2024 Jan 8;11:1304982. doi: 10.3389/fpubh.2023.1304982. eCollection 2023.

    PMID: 38259747DERIVED

MeSH Terms

Conditions

FrailtyMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Luis García-Ortiz, Dr

    Primary Health Care Research Unit

    STUDY CHAIR

Central Study Contacts

Emiliano Rodríguez-Sánchez, Dr

CONTACT

923231859emiliano@usal.es

Luis García-Ortiz, Dr

CONTACT

635542886lgarciao@usal.es

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

June 11, 2023

First Posted

June 22, 2023

Study Start

March 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 31, 2025

Last Updated

October 18, 2023

Record last verified: 2023-06

Locations

ES(1)