Detection of Balance in the Elderly Under the Influence of Stress

NCT ID: NCT06682754

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2026-07-31

Brief Summary

The aging process involves physiological changes in organs and tissues that can evolve towards fragility and increased risk of falls. Falls, which can be one of the adverse results of frailty in older people, are the second leading cause of death worldwide. When an elderly person falls, it entails not only hospitalization, immobilization, and the consequent deterioration, but also usually causes fear of falling again, which can also lead to the onset of disability. The inherent aging process can be linked to the deterioration of postural control and balance, posing serious health problems. In falls in the elderly, both sensorimotor and cognitive functions are affected, the functioning of which is degraded to a greater extent by anxiety and stress. Nowadays, more extensive, and more precise research is needed in the study of the interactions between cognition, stress, and postural control in the context of postural instability and falls in older adults.

The purpose of the DEPIE Project is to detect whether neuromuscular changes that occur when exposed to stressful situations can affect the postural and motor control of the elderly.

To this end, all participants will undergo the same intervention. Firstly, they will all take a baseline cognitive and physical assessment. Afterwards, they will take the experimental session, which will consist of a baseline test and an experimental test. During the baseline test, participants will visualize International Affective Picture System (IAPS) images of low arousal and during the experimental test of high arousal. Finally, physical assessment tests will be repeated.

Young and older adults will be tested. Additionally, sub-analyses will be conducted within the elderly group differentiating the degree of cognitive impairment and functional dependence.

The primary outcome measures will be surface electromyography, pressures on the floor, activity on manipulation, and balance.

The secondary outcome measures will be heart rate variability, respiratory rate and the visual analogue scale on unease after visualisation of the images.

Conditions

Balance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Experimental

All participants will perform a baseline and an experimental test. There will be a group of young people and a group of older people, but all participants will perform the same intervention

Group Type: EXPERIMENTAL

Stress

Intervention Type: OTHER

All participants will perform a baseline test in which they will first be asked to visualize low-arousal IAPS images for three minutes while seated in a chair, and then get up, walk to a table with two bottles, transfer liquid from one bottle to the other, return to the starting chair and sit down again. Subsequently, they will perform an experimental test, where they will repeat the same movements as in the baseline test after visualizing high-arousal IAPS images for three minutes. In addition, IAPS images will continue to be projected in the background while participants perform the described motor tasks.

Interventions

Stress

All participants will perform a baseline test in which they will first be asked to visualize low-arousal IAPS images for three minutes while seated in a chair, and then get up, walk to a table with two bottles, transfer liquid from one bottle to the other, return to the starting chair and sit down again. Subsequently, they will perform an experimental test, where they will repeat the same movements as in the baseline test after visualizing high-arousal IAPS images for three minutes. In addition, IAPS images will continue to be projected in the background while participants perform the described motor tasks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Young adults (ages 18-39).
• Older adults (≥65).
• Voluntarily participate in the study.

Exclusion Criteria

• Any disease, injury, or previous trauma that contraindicates muscular exertion, balance exercises, and/or walking.
• Any physical or mental illness that contraindicates exposure to stimuli generating emotional stress, such as severe depression or severe psychosis
• Difficulties in understanding study information and providing informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Castilla-La Mancha Health Service

OTHER

Sponsor Role: collaborator

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Susana Nunez Nagy

PhD. Associate Professor.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana N Núñez, PhD. Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Bernardo A Alarcos, PhD. Full Professor

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

University of Alcalá

Alcalá de Henares, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Susana N Núñez, PhD. Associate Professor

Role: CONTACT

susana.nunez@uah.es

0034918852524

Facility Contacts

Susana N Núñez, PhD. Associate Professor

Role: primary

susana.nunez@uah.es

0034918852524

Other Identifiers

CEIP/2023/5/110

Identifier Type: -

Identifier Source: org_study_id