NCT05682872

Brief Summary

The main objective is evaluate the effectiveness of a Multifactorial Pilot Program on the Prevention of Falls in people aged 65 or over during 4 years at Gerencia de Atención Integrada de Talavera de la Reina.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress91%
Mar 2021Nov 2026

Study Start

First participant enrolled

March 9, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

December 13, 2022

Last Update Submit

July 14, 2025

Conditions

Frail Elderly Syndrome

Keywords

risk of fallspreventionclinical trial

Outcome Measures

Primary Outcomes (1)

  • Number of falls

    To assess the number of falls in the intervention group and control group to determine if the intervention group has a significantly lower rate of falls.

    24 months after intervention

Secondary Outcomes (2)

  • Number of falls that have been treated in hospital

    24 months after intervention

  • Euroqol-5D-5L

    24 months after intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).

Behavioral: Physical exercise program (VIVIFRAIL) supervised by a physiotherapistBehavioral: Adequacy of the environmentBehavioral: Polypharmacy reviewBehavioral: Health education related to falls prevention (4 sessions)Behavioral: General AssementBehavioral: Evaluation of patients by an expert groupBehavioral: Information brochures on the importance of physical exercise

Control Group

ACTIVE COMPARATOR

Control group receive activities on falls prevention by Primary Care professionals on a care routine.

Behavioral: Information brochures on the importance of physical exerciseBehavioral: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurseBehavioral: Regular assessment and follow-up by primary care doctor and primary care nurseBehavioral: Health education related to falls prevention (1 session)

Interventions

Physical exercise program (VIVIFRAIL) supervised by a physiotherapistBEHAVIORAL

Promotion of physical exercise program for frailty and falls prevention in elderly. Muscular strength training, cardiovascular resistance, balance and gait. Initially guided and supervised every 3 months by a physiotherapist.

Experimental Group
Adequacy of the environmentBEHAVIORAL

A home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit.

Experimental Group
Polypharmacy reviewBEHAVIORAL

Assessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine.

Experimental Group
Health education related to falls prevention (4 sessions)BEHAVIORAL

SESSION 1: Fall Risk factors. Pharmacology. Nutrition and falls (Primary Care Doctor and Primary Care Nurse) SESSION 2: Accident prevention through environmental modification (Occupational Therapist) SESSION 3: Importance of physical exercise to prevent falls (Physiotherapist) SESSION 4: Footwear and foot care. How to react to a fall?: what to do and how to get up? (Primary Care Nurse)

Experimental Group
General AssementBEHAVIORAL

General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse

Experimental Group
Evaluation of patients by an expert groupBEHAVIORAL

Evaluation of the patient by an expert group (Primary care doctor, primary care nurse, polypharmacy review doctor, occupational therapist, frailty group) and decision-making for correction of fall risk factors.

Experimental Group
Information brochures on the importance of physical exerciseBEHAVIORAL

Integrated Assistance Process for prevention falls in elderly. Benefits of physical exercise and fall prevention at home. Prepared by the Junta de Comunidades de Castilla-La Mancha and Servicio de Salud de Castilla-La Mancha.

Control GroupExperimental Group
Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurseBEHAVIORAL

Promotion of physical exercise program for frailty and falls prevention in elderly. Muscular strength training, cardiovascular resistance, balance and gait. Supervised by primary care doctor o primary care nurse according to passport recommendations.

Control Group
Regular assessment and follow-up by primary care doctor and primary care nurseBEHAVIORAL

General assessment related to falls with the established protocols at primary care routine.

Control Group
Health education related to falls prevention (1 session)BEHAVIORAL

There will be a single session. The session will cover the following topics: Fall Risk factors. Pharmacology. Nutrition and falls. Accident prevention through environmental modification. Importance of physical exercise to prevent falls. Footwear and foot care. How to react to a fall?: what to do and how to get up?

Control Group

Eligibility Criteria

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

You may qualify if:

  • years old or older patients
  • Live in Talavera de la Reina
  • Ability to walk at the Health Center
  • ≥ 3 in the Downton Test
  • \> 90 in the Barthel Index
  • Sign the informed consent

You may not qualify if:

  • Patients with an intense physical activity
  • Use of a wheelchair
  • Amputations or prosthetic limbs
  • Deafness
  • Blindness
  • Moderate or severe cognitive impairment
  • Vertebral, pelvic or lower limb fractures in the 12 months prior to entering the program
  • Absolute contraindication to physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia de Atención Integrada de Talavera de la Reina

Talavera de la Reina, Toledo, 45600, Spain

Location

Related Publications (11)

  • Aranda-Gallardo M, Morales-Asencio JM, Canca-Sanchez JC, Toribio-Montero JC. Circumstances and causes of falls by patients at a Spanish acute care hospital. J Eval Clin Pract. 2014 Oct;20(5):631-7. doi: 10.1111/jep.12187. Epub 2014 Jun 5.

    PMID: 24902772BACKGROUND

  • Viana TS, Martin MR, Crespo FN, Rodriguez EM, Merino GM, Ruiz JM, Lorenzo IL, Quintas CG. [What is the real incidence of falls in hospitals?]. Enferm Clin. 2011 Sep-Oct;21(5):271-4. doi: 10.1016/j.enfcli.2011.02.011. Epub 2011 Jun 30. Spanish.

    PMID: 21719335BACKGROUND

  • Silva Gama ZA, Gomez Conesa A, Sobral Ferreira M. [Epidemiology of falls in the elderly in Spain: a systematic review, 2007]. Rev Esp Salud Publica. 2008 Jan-Feb;82(1):43-55. doi: 10.1590/s1135-57272008000100004. Spanish.

    PMID: 18398550BACKGROUND

  • Ambrose AF, Cruz L, Paul G. Falls and Fractures: A systematic approach to screening and prevention. Maturitas. 2015 Sep;82(1):85-93. doi: 10.1016/j.maturitas.2015.06.035. Epub 2015 Jun 26.

    PMID: 26255681BACKGROUND

  • Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

    PMID: 22972103BACKGROUND

  • Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE. Multifactorial and multiple component interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD012221. doi: 10.1002/14651858.CD012221.pub2.

    PMID: 30035305BACKGROUND

  • Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.

    PMID: 27707740BACKGROUND

  • Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.

    PMID: 24339273BACKGROUND

  • Izquierdo M, Casas-Herrero A, Zambm-Ferraresi F, Martínez-Velilla N, Alonso-Bouzón C, Rodríguez-Mañas L, et al. A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70. 2017. http://www.vivifrail.com/resources.

    BACKGROUND

  • Sepulveda-Loyola W, Rodriguez-Sanchez I, Perez-Rodriguez P, Ganz F, Torralba R, Oliveira DV, Rodriguez-Manas L. Impact of Social Isolation Due to COVID-19 on Health in Older People: Mental and Physical Effects and Recommendations. J Nutr Health Aging. 2020;24(9):938-947. doi: 10.1007/s12603-020-1469-2.

    PMID: 33155618BACKGROUND

  • Jutkowitz E, Gitlin LN, Pizzi LT, Lee E, Dennis MP. Cost effectiveness of a home-based intervention that helps functionally vulnerable older adults age in place at home. J Aging Res. 2012;2012:680265. doi: 10.1155/2012/680265. Epub 2011 Aug 16.

    PMID: 21876812BACKGROUND

Related Links

Study Officials

  • Nuria García Bonilla

    Gerencia de Atención Integrada de Talavera de la Reina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 12, 2023

Study Start

March 9, 2021

Primary Completion (Estimated)

October 9, 2026

Study Completion (Estimated)

November 9, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)