An interventional study of Physical exercise program (VIVIFRAIL) supervised by a physiotherapist and Adequacy of the environment in Frail Elderly Syndrome, sponsored by Castilla-La Mancha Health Service. Active, not recruiting at 1 site in Spain. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Castilla-La Mancha Health Service · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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 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 receive activities on falls prevention by Primary Care professionals on a care routine.
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)
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.
A home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit.
Assessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine.
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 assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse
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.
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.
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.
General assessment related to falls with the established protocols at primary care routine.
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?
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.
Time frame: 24 months after intervention
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
Time frame: 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
Time frame: 24 months after intervention
Plan to share: No
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Castilla-La Mancha Health Service