Population Cohort Set-up for the Epidemiological Assessment of Balance Disorders in Elderly People

NCT06965660 | Active Not Recruiting

• 1 other identifier: PI20/00406
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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%.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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

  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.

  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.

  Baseline, 6-month follow-up, and 18-month follow-up

Secondary Outcomes (2)

• Health Assessment Tool (HAT)

  6-month follow-up

• Retinography

  Baseline and 18-month follow-up

Other Outcomes (8)

• Short Falls Efficacy Scale - International (Short FES-I)

  Baseline and 18-month follow-up

• History of Falls

  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

  Baseline and 18-month follow-up

Study Arms (1)

Age-based cohort of people aged 65-75 living in Mataró, Spain

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

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Aged 65-75.
• Reside in Mataró.
• Able to walk independently, with or without technical assistance.

You may not qualify if:

• Unable to walk independently.
• Terminal illness or severe cognitive decline.
• Incompetence in Catalan or Spanish.
• Lack of phone access.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Karolinska Institutet: collaborator
• Fundació Tecnocampus Mataró-Maresme: collaborator
• Fundació Institut Germans Trias i Pujol: collaborator
• Universidade da Coruña: collaborator

Study Sites (1)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina - USR Metropolitan North.

Mataró, Barcelona, 08303, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Medicine and Surgery. PhD medicine.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2022
• Primary Completion: April 10, 2025
• Study Completion: October 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)