An observational study in Balance Disorders, Accidental Falls and Frailty, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Active, not recruiting at 1 site in Spain. Open to participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Observational
As people age, it becomes more common to experience balance problems. These issues can increase the risk of falling, which may lead to serious health consequences and loss of independence. While many studies have looked at falls in older adults, there is still limited information about how many people actually have balance disorders, how these disorders develop over time, and which factors might help detect them early-before a fall happens.
This clinical study aims to understand how common balance disorders are among older adults aged 65 to 75, how they change over time, and which simple, accessible tools might help us predict who is at risk. The study will include over 1,300 participants living in Mataró (Barcelona, Spain), who will be followed for a period of 18 months.
Participants will undergo a series of assessments to measure their balance, leg strength, and general health. One key test is posturography, an advanced method that evaluates how well a person can maintain balance. In addition, the study will explore the use of a simple tool-the Nintendo Wii™ Balance Board-as a low-cost way to detect balance issues. Retinal photographs will also be taken to study the small blood vessels in the eye, which may reflect changes in brain circulation that affect balance. Lastly, a tool called the Health Assessment Tool (HAT) will be used to assess participants' overall physical and cognitive function.
The study hypothesizes that certain indicators-such as leg strength, changes in retinal blood vessels, balance performance using tools like the Wii™, and overall health assessments (HAT)-can help predict who is at greater risk for balance problems and falls. The study also explores whether posturography, as a gold-standard method, can reveal how balance disorders are related to the risk and consequences of falling.
Detecting balance problems early can help prevent falls, reduce the risk of injury, and support older adults in maintaining their independence. This study may help identify easy and effective methods to screen for balance disorders, improving quality of life for older adults and reducing the personal and healthcare costs associated with falls.
Background:
Poor balance leads to falls, which can result in loss of personal autonomy and reduced quality of life. Epidemiological studies on balance disorders (BDs) remain scarce. It is essential to determine the prevalence and incidence of BDs and to identify potential markers that facilitate their detection and monitoring in an accessible and practical way.
Aims:
Methods:
This is a two-phase observational study.
Applicability and relevance:
BDs are often underdiagnosed and undertreated. Current awareness of the problem is limited. Enhancing knowledge in this field is crucial to prevent the loss of functional autonomy and to develop targeted preventive strategies for those at highest risk of falls. This will allow for a more efficient and evidence-based approach to this prevalent geriatric syndrome.
1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.
This study's enrollment of 1,300 is above the median of 223 across 496 observational studies indexed under Frailty.
Browse Frailty studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
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The target population is an age-based cohort of people aged 65-75 living in Mataró. This age range was selected to find individuals who do not yet have BDs, enabling the calculation of the incidence. According to the 2017 municipal register, and the population's age structure, there are 2,215 people in this age range. A total of 1,316 people will be randomly selected to form a sample stratified by gender and age from the Primary Care Information System (SIAP) database, which includes health cardholders. The SIAP is not as exhaustive or up-to-date as the population census. This register includes any individual ascribed to a primary care center (covering nearly the entire population), regardless of whether or not they have used this health service and whether they are healthy or ill. Our research team will contact the selected participants using the phone number registered in the SIAP and invite them to take part in the study.
Exclusion Criteria:
Eligibility criteria: * Aged 65-75. * Reside in Mataró. * Able to walk independently, with or without technical assistance. Exclusion criteria: * Unable to walk independently. * Terminal illness or severe cognitive decline. * Incompetence in Catalan or Spanish. * Lack of phone access
Posturography
Static posturography measures the displacement of the center of pressure while standing on a force platform. Greater sway indicates poorer balance control. Also looks at dynamic stability. The balance assessment is based on the comparison of the parameters that best discriminate the pathology of the general population with those obtained from patterns of normality segmented by age (database of the Institute of Biomechanics of Valencia). Ratings are displayed in percentages, so that results other than 100% reflect discrepancy with respect to normal values. It is considered pathological when the results are less than 95%, indicating that these subjects are more likely to present an alteration in the studied system. Pathological values for the limits of stability are considered to be below 85%.
Time frame: Baseline and 18-month follow-up
Unipedal Stance Test
The test measures whether the participant is able to stand on one leg without support for 5 seconds.
Time frame: Baseline and 18-month follow-up
Timed Up and Go (TUG) Test
Time in seconds taken to rise from a chair, walk 3 meters, turn around, return, and sit down again. Shorter times indicate better functional mobility and lower fall risk.
Time frame: Baseline and 18-month follow-up
Tinetti Test
The Tinetti assesses gait and balance. It consists of two components: balance (maximum 16 points) and gait (maximum 12 points), for a total score ranging from 0 to 28 points. Higher scores indicate better balance and gait performance, and lower risk of falls.
Time frame: Baseline and 18-month follow-up
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery is an objective tool for measuring functional capacity, balance, and lower limb strength in adults over 65 years old. The test includes three different domains to assess functional mobility: gait, sit-to-stand, and balance. A score below 8 indicates mobility and physical exercise limitations and is associated with a higher risk of mobility disability and, consequently, a higher risk of falls. A score of 8 or higher is considered within the normal range.
Time frame: Baseline and 18-month follow-up
Balance Assessment Using the Nintendo Wii Console
This includes the test of the gimp leg and center of gravity assessment, as well as Romberg Test variants: Eyes Open (REO), Eyes Closed (REC), and on Foam Pad (RuFP), as performed in the posturography test. The Nintendo Wii provides accurate measures of body center of pressure (COP), an important metric for balance stability assessment approximating the body's center of mass. The Romberg test assesses gait disturbance caused by abnormal proprioception, disequilibrium from central vertigo, and peripheral vertigo. Patients is asked to stand with feet together, arms next to the body, first with eyes open and then closed. The patient tries to maintain his balance. The test is scored by counting the seconds the patient can stand with eyes closed.
Time frame: Baseline and 18-month follow-up
Muscle Strength of Lower Limbs
Measurement of force in kilograms of the lower extremities using a hand-held dynamometer or similar device. Higher values indicate greater muscle strength
Time frame: Baseline and 18-month follow-up
Gait Speed
Measurement of usual walking speed (in seconds) over a distance of 6 meters. Higher speeds indicate better functional mobility.
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
Physical activity measured using the abbreviated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (VREM)
The VREM is a short version in Spanish of the Minnesota Leisure Time Physical Activity Questionnaire (CAFM). It is a tool designed to assess the quality and quantity of physical activity performed during leisure time. It consists of 6 items that evaluate the physical activity performed in the last month, taking into account only the activities performed during free time. The energy expenditure is quantified in MET-min/14 days by multiplying the METs of each physical activity by its duration (in minutes) by the frequency accumulated in the month prior to the interview and by the months of the year in which the activity was performed. Furthermore, it is divided by 365 days/year and multiplied by 14 days. Then, it is classified according to the energetic cast: * Very active: Energy index higher than 5,000 METs-min/14 days. * Active: Energy index between 3,000 and 4,999 METs-min/14 days. * Moderately active: Energy index between 1,250 and 2,999 METs-min/14 days. * Sedentary: Energy index
Time frame: Baseline and 18-month follow-up
Lawton-Brody Instrumental Activities of Daily Living (IADL)
The scale evaluates complex daily activities (e.g., cooking, managing finances). Scores range from 0 (low function, dependent) to 8 (high function, independent). Higher scores indicate better functional capacity.
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
Barthel Index of Activities of Daily Living (ADL)
Assesses performance in basic activities such as bathing, dressing, and feeding. Scores range from 0 to 100. Higher scores indicate greater independence.
Time frame: Baseline, 6-month follow-up, and 18-month follow-up
Health Assessment Tool (HAT)
Health status will be assessed using the Health Assessment Tool (HAT), a composite measure integrating the following five health dimensions: 1. Physical function, assessed by gait speed (measured over 4 meters); 2. Cognitive function, assessed by the Mini-Mental State Examination (MMSE), ranging from 0 to 30, with higher scores indicating better cognitive function; 3. Chronic morbidity, determined by the number of diagnosed chronic conditions recorded using the ICD-10 classification system; 4. Mild disability, assessed using the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale, excluding household tasks to reduce gender bias; 5. Severe disability, assessed using the Barthel Index for basic activities of daily living (ADLs), focusing on five essential self-care tasks (bathing, toileting, transferring, eating, and dressing). These dimensions will be combined to generate a composite health status profile, according to the HAT methodology.
Time frame: 6-month follow-up
Retinography
Retinal images will be analyzed to assess microvascular parameters using two software tools: 1. IMEDOS Vessel Map software (IMEDOS Systems UG, Germany) will be used to measure retinal vessel diameters and calculate central retinal arteriolar equivalent (CRAE), central retinal venular equivalent (CRVE), and arteriolar-to-venular ratio (AVR). 2. SIRIUS software (University of A Coruña) will be used to calculate retinal vessel tortuosity and arteriovenous (A/V) ratio. These parameters serve as non-invasive biomarkers of microvascular health.
Time frame: Baseline and 18-month follow-up
Short Falls Efficacy Scale - International (Short FES-I)
Fear of falling will be assessed using the Short Falls Efficacy Scale - International (Short FES-I), a 7-item self-reported questionnaire that evaluates concern about falling during basic daily activities. Each item is rated from 1 (not at all concerned) to 4 (very concerned), yielding a total score from 7 to 28. Higher scores indicate greater fear of falling.
Time frame: Baseline and 18-month follow-up
History of Falls
Participants will self-report the number of falls experienced in the 12 months preceding study enrollment, along with fall-related consequences (e.g., injuries, fractures, hospitalizations). The variable includes both quantitative (number of falls) and qualitative (presence of consequences) components.
Time frame: Every 2 months from baseline through month 18 (i.e., at months 0, 2, 4, 6, 8, 10, 12, 14, and 18)
Charlson Comorbidity Index
Comorbidity will be assessed using the Charlson Comorbidity Index (CCI), a validated method for classifying prognostic comorbidity in longitudinal studies. The CCI assigns weighted scores based on the presence of 17 predefined chronic conditions. Additionally, the total number of chronic conditions and specific ICD-10 diagnoses recorded in the patient's electronic health record will be documented.
Time frame: Baseline and 18-month follow-up
Mini-Mental State Examination (MMSE)
Cognitive function will be assessed using the MMSE, a 30-item scale. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Baseline and 18-month follow-up
Pfeiffer Short Portable Mental State Questionnaire (SPMSQ)
Cognitive impairment will be assessed using the SPMSQ, a 9-item scale. Scores range from 0 to 9 errors. Scores greater than 5 errors indicate moderate to severe cognitive impairment.
Time frame: Baseline
UCLA-3 Loneliness Scale
Perceived loneliness will be assessed using the 3-item UCLA Loneliness Scale (UCLA-3), which evaluates subjective feelings of social isolation and lack of companionship. Each item is scored from 1 (hardly ever) to 3 (often), for a total score ranging from 3 to 9. Higher scores indicate greater loneliness.
Time frame: Baseline or 18-month follow-up
De Jong Gierveld Loneliness Scale
Loneliness will also be assessed using the De Jong Gierveld Loneliness Scale, a validated 6-item questionnaire that distinguishes between emotional and social loneliness. Items are scored and interpreted following the official scoring algorithm, with higher scores indicating greater loneliness.
Time frame: Baseline or 18-month follow-up
Blood Sample
Blood samples will be collected from participants for future analysis of biomarkers related to frailty and sarcopenia. The collected samples will be stored for use in subsequent studies aimed at identifying and validating relevant biomarkers.
Time frame: Baseline
Plan to share: No
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina