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

NCT ID: NCT06965660

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-10-31

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.

Conditions

Balance Disorders; Accidental Falls; Frailty; Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Fundació Tecnocampus Mataró-Maresme

OTHER

Sponsor Role: collaborator

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role: collaborator

Universidade da Coruña

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Pilar Montero Alía

Bachelor of Medicine and Surgery. PhD medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Mataró, Barcelona, Spain

Countries

Spain

Other Identifiers

PI20/00406

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI20/00406

Identifier Type: -

Identifier Source: org_study_id