Frail Elderly SyndromeDodgersNCT05682872
Multifactorial Fall Prevention Program
A study testing Physical exercise program (VIVIFRAIL) supervised by a physiotherapist, Adequacy of the environment and Polypharmacy review in people with Frail Elderly Syndrome, run by Castilla-La Mancha Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Physical exercise program (VIVIFRAIL) supervised by a physiotherapist, Adequacy of the environment and Polypharmacy review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2021to 9 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gerencia de Atención Integrada de Talavera de la Reina
Talavera de la Reina, Toledo, 45600
About this study
Official title: Multifactorial Fall Prevention Program in People Aged 65 or Over of an Urban Area of Talavera de la Reina
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.
Read the detailed description
Introduction: Falls are a major global public health problem. Falls are the second leading cause of death from unintentional injuries in the world. The highest mortality rates correspond to 60 years old people. 20-30% suffer from moderate-serious injuries (hip fractures, head injuries...), that reduce mobility and independence, increasing the risk of premature death. Moreover, there are more than 400 risk factors. Most can be modified to decrease the risk of falling.
Objective: To 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.
Material and methods: Randomized clinical trial with 264 patients is carried out. 65 years old or older patients are recruited from primary care (≥ 1 positive response in the Frailty Screening Test, or ≥ 3 in the Downton Test and > 90 in the Barthel Index). Falls risk is assessed using validated scales. Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). Control group receive recommendations (physical exercise, health education on risk factors, footwear, exercise, home adaptation, nutrition, …). Variables are presented with their frequency distribution. Qualitative variables as median and range, and quantitatives with their mean and standard deviation. Association between qualitative variables are evaluated with Pearson's Chi-square test. Student's t test be used when the distribution of the variable adjusts to normality. The null hypothesis will be rejected with an error α less than 0.05.
Expected benefits: It is expected to reduce the risk of falls in 30-35% of 65 years old people or older in the urban area of Talavera de la Reina. It would mean great savings and improve the quality of life. It is expected to increase the years of healthy life. It is intended to provide health professionals with a tool to make clinical decisions based on evidence on the prevention of falls to be used as a unified work protocol at Gerencia de Atención Integrada de Talavera de la Reina.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Physical exercise program (VIVIFRAIL) supervised by a physiotherapist, Adequacy of the environment, Polypharmacy review, Health education related to falls prevention (4 sessions), General Assement
- Keywords
- risk of falls, prevention, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise program (VIVIFRAIL) supervised by a physiotherapistBehavioural
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.
Adequacy of the environmentBehavioural
A home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit.
Polypharmacy reviewBehavioural
Assessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine.
Health education related to falls prevention (4 sessions)Behavioural
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)
General AssementBehavioural
General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse
Evaluation of patients by an expert groupBehavioural
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.
Information brochures on the importance of physical exerciseBehavioural
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.
Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurseBehavioural
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.
Regular assessment and follow-up by primary care doctor and primary care nurseBehavioural
General assessment related to falls with the established protocols at primary care routine.
Health education related to falls prevention (1 session)Behavioural
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?
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). Receives: Behavioral: Physical exercise program (VIVIFRAIL) supervised by a physiotherapist; Behavioral: Adequacy of the environment; Behavioral: Polypharmacy review; Behavioral: Health education related to falls prevention (4 sessions); Behavioral: General Assement; Behavioral: Evaluation of patients by an expert group; Behavioral: 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. Receives: Behavioral: Information brochures on the importance of physical exercise; Behavioral: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse; Behavioral: Regular assessment and follow-up by primary care doctor and primary care nurse; Behavioral: Health education related to falls prevention (1 session) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after intervention
Secondary outcomes (2)
Number of falls that have been treated in hospital
Evaluate the number of falls that have been treated in hospital due to fractures or trauma resulting from falls
Measured: 24 months after intervention
Euroqol-5D-5L
Evaluate the impact on the quality of life in people over 65 years of age who live in the community and who participate in this program
Measured: 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start9 Mar 2021
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha, Fundación Eurocaja Rural, Fundación Hestia, Unidad de Apoyo a la Investigación de la Gerencia de Atención Integrada de Talavera de la Reina, Decathlon España S.A.U.
- Responsible party
- Sponsor
- Investigators
- Nuria García Bonilla, Principal investigator, Gerencia de Atención Integrada de Talavera de la Reina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682872
- Sponsor's protocol ID
- 57/2020
- Acronym
- Dodgers
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24902772Viana 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.
PubMed 21719335Silva 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.
PubMed 18398550Ambrose 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.
PubMed 26255681Gillespie 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.
PubMed 22972103Hopewell 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.
PubMed 30035305Sherrington 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.
PubMed 27707740Kyrdalen 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.
PubMed 24339273Izquierdo 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.
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.
PubMed 33155618Jutkowitz 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.
PubMed 21876812
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Fall Prevention Program in People Aged 65 or Over of an Urban Area of Talavera de la Reina
- ClinicalTrials.gov ID
- NCT05682872
- Acronym / sponsor ID
- Dodgers / 57/2020
- Conditions
- Frail Elderly Syndrome
- Keywords
- risk of falls, prevention, clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Collaborators
- Colegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha, Fundación Eurocaja Rural, Fundación Hestia, Unidad de Apoyo a la Investigación de la Gerencia de Atención Integrada de Talavera de la Reina, Decathlon España S.A.U.
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Falls are a major global public health problem. Falls are the second leading cause of death from unintentional injuries in the world. The highest mortality rates correspond to 60 years old people. 20-30% suffer from moderate-serious injuries (hip fractures, head injuries...), that reduce mobility and independence, increasing the risk of premature death. Moreover, there are more than 400 risk factors. Most can be modified to decrease the risk of falling.
Objective: To 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.
Material and methods: Randomized clinical trial with 264 patients is carried out. 65 years old or older patients are recruited from primary care (≥ 1 positive response in the Frailty Screening Test, or ≥ 3 in the Downton Test and > 90 in the Barthel Index). Falls risk is assessed using validated scales. Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). Control group receive recommendations (physical exercise, health education on risk factors, footwear, exercise, home adaptation, nutrition, …). Variables are presented with their frequency distribution. Qualitative variables as median and range, and quantitatives with their mean and standard deviation. Association between qualitative variables are evaluated with Pearson's Chi-square test. Student's t test be used when the distribution of the variable adjusts to normality. The null hypothesis will be rejected with an error α less than 0.05.
Expected benefits: It is expected to reduce the risk of falls in 30-35% of 65 years old people or older in the urban area of Talavera de la Reina. It would mean great savings and improve the quality of life. It is expected to increase the years of healthy life. It is intended to provide health professionals with a tool to make clinical decisions based on evidence on the prevention of falls to be used as a unified work protocol at Gerencia de Atención Integrada de Talavera de la Reina.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Physical exercise program (VIVIFRAIL) supervised by a physiotherapist, Behavioral: Adequacy of the environment, Behavioral: Polypharmacy review, Behavioral: Health education related to falls prevention (4 sessions), Behavioral: General Assement, Behavioral: Evaluation of patients by an expert group, Behavioral: Information brochures on the importance of physical exerciseExperimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). |
| Control Group | Active comparator | Behavioral: Information brochures on the importance of physical exercise, Behavioral: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse, Behavioral: Regular assessment and follow-up by primary care doctor and primary care nurse, Behavioral: Health education related to falls prevention (1 session)Control group receive activities on falls prevention by Primary Care professionals on a care routine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 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
Key exclusion criteria (8 listed)
- Patients with an intense physical activity
- Use of a wheelchair
- Amputations or prosthetic limbs
- Deafness
- Blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise program (VIVIFRAIL) supervised by a physiotherapistPromotion 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. | Behavioural | Experimental Group |
| Adequacy of the environmentA home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit. | Behavioural | Experimental Group |
| Polypharmacy reviewAssessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine. | Behavioural | Experimental Group |
| Health education related to falls prevention (4 sessions)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) | Behavioural | Experimental Group |
| General AssementGeneral assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse | Behavioural | Experimental Group |
| Evaluation of patients by an expert groupEvaluation 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. | Behavioural | Experimental Group |
| Information brochures on the importance of physical exerciseIntegrated 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. | Behavioural | Control Group, Experimental Group |
| Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nursePromotion 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. | Behavioural | Control Group |
| Regular assessment and follow-up by primary care doctor and primary care nurseGeneral assessment related to falls with the established protocols at primary care routine. | Behavioural | Control Group |
| Health education related to falls prevention (1 session)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? | Behavioural | Control Group |
Primary outcome
Number of falls
Time frame: 24 months after intervention
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.
2 secondary outcomes
Number of falls that have been treated in hospital
Time frame: 24 months after intervention
Euroqol-5D-5L
Time frame: 24 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 24902772Aranda-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.
- Background: PubMed 21719335Viana 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.
- Background: PubMed 18398550Silva 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.
- Background: PubMed 26255681Ambrose 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.
- Background: PubMed 22972103Gillespie 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.
- Background: PubMed 30035305Hopewell 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.
- Background: PubMed 27707740Sherrington 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.
- Background: PubMed 24339273Kyrdalen 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.
- BackgroundIzquierdo 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: PubMed 33155618Sepulveda-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.
- Background: PubMed 21876812Jutkowitz 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.
- World Health Organization. falls. Fact Sheet no 344.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuria García Bonilla principal investigator
Gerencia de Atención Integrada de Talavera de la Reina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise program (VIVIFRAIL) supervised by a physiotherapist, Adequacy of the environment and Polypharmacy review in people with Frail Elderly Syndrome, run by Castilla-La Mancha Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls (time frame: 24 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682872, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.