Clinical trial NCT06965660: Population Cohort Set-up for the Epidemiological Assessment of Balance Disorders in Elderly People
Official title: Prevalence and Burden of Balance Disorders in Community-dwelling Older Adults: A Population-based Study Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Balance Disorders
Accidental Falls
Frailty
Aging
Keywords: Postural balance
Balance disorders
Falls
Posturography
Retinal microvasculature
Nintendo Wii Balance Board™
Knee extensor strength
Aging
Prevalence
Health Assessment Tool (HAT)
Cognitive function
Epidemiology
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Fundació Tecnocampus Mataró-Maresme
name: Fundació Institut Germans Trias i Pujol
name: Universidade da Coruña
First posted: 2025-05-11
Enrollment: 1300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

* To assess the prevalence of BDs in men and women aged 65-72 using posturography and a variety of balance tests, and to monitor the annual incidence of BDs.
* To analyze the relationship between retinal microvasculature abnormalities and balance impairments.
* To evaluate the effectiveness of the Wii Balance Board™ as a tool for balance assessment compared to posturography.
* To explore whether knee extensor strength and a composite measure of physical and cognitive function can serve as predictors of BDs and fall risk.
* To externally validate the Health Assessment Tool (HAT scale) in the Spanish population.

Methods:

This is a two-phase observational study.

* Phase I: Descriptive, cross-sectional.
* Phase II: Cohort follow-up at 18 months. A total of 1,316 individuals aged 65-75 residing in Mataró (Barcelona, Spain) will be included, excluding those unable to walk independently. Participants will undergo posturography, retinal imaging, knee extensor strength measurement, and a battery of functional tests: Tinetti Test, Timed Up and Go test, Unipedal Stance Test, Short Physical Performance Battery (SPPB), and balance assessment using the Nintendo Wii at baseline and at the end of follow-up. Bimonthly phone calls will be conducted to detect fall events.

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.

Eligibility criteria: Inclusion 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.

Primary outcomes:
measure: Posturography
timeFrame: Baseline and 18-month follow-up
measure: Unipedal Stance Test
timeFrame: Baseline and 18-month follow-up
measure: Timed Up and Go (TUG) Test
timeFrame: Baseline and 18-month follow-up
measure: Tinetti Test
timeFrame: Baseline and 18-month follow-up
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 18-month follow-up
measure: Balance Assessment Using the Nintendo Wii Console
timeFrame: Baseline and 18-month follow-up
measure: Muscle Strength of Lower Limbs
timeFrame: Baseline and 18-month follow-up
measure: Gait Speed
timeFrame: Baseline, 6-month follow-up, and 18-month follow-up
measure: Physical activity measured using the abbreviated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (VREM)
timeFrame: Baseline and 18-month follow-up
measure: Lawton-Brody Instrumental Activities of Daily Living (IADL)
timeFrame: Baseline, 6-month follow-up, and 18-month follow-up
measure: Barthel Index of Activities of Daily Living (ADL)
timeFrame: Baseline, 6-month follow-up, and 18-month follow-up
Secondary outcomes:
measure: Health Assessment Tool (HAT)
timeFrame: 6-month follow-up
measure: Retinography
timeFrame: Baseline and 18-month follow-up
Other outcomes:
measure: Short Falls Efficacy Scale - International (Short FES-I)
timeFrame: Baseline and 18-month follow-up
measure: History of Falls
timeFrame: Every 2 months from baseline through month 18 (i.e., at months 0, 2, 4, 6, 8, 10, 12, 14, and 18)
measure: Charlson Comorbidity Index
timeFrame: Baseline and 18-month follow-up
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline and 18-month follow-up
measure: Pfeiffer Short Portable Mental State Questionnaire (SPMSQ)
timeFrame: Baseline
measure: UCLA-3 Loneliness Scale
timeFrame: Baseline or 18-month follow-up
measure: De Jong Gierveld Loneliness Scale
timeFrame: Baseline or 18-month follow-up
measure: Blood Sample
timeFrame: Baseline
Locations:
city: Mataró
country: Spain
facility: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina - USR Metropolitan North.
state: Barcelona
Study officials:
References: