Detection of Balance in the Elderly Under the Influence of Stress (DEPIE)

Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)

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.

Study Overview

• Status: Recruiting
• Conditions: Balance
• Intervention / Treatment: Other: Stress

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana N Núñez, PhD. Associate Professor; Phone Number: 0034918852524; Email: susana.nunez@uah.es

Study Locations

• Spain
  • Alcalá de Henares, Spain
    • Recruiting
    • University of Alcalá
    • Contact: Susana N Núñez, PhD. Associate Professor; Phone Number: 0034918852524; Email: susana.nunez@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Young adults (ages 18-39).
• Older adults (≥65).
• Voluntarily participate in the study.
• Not meeting the exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressures on the floor	They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour	It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
Triaxial accelerometry: acceleration and deceleration in object handling	The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.	It will be assessed while performing the bottle manipulation movement (during which liquid has to be transferred from one bottle to another), both during the baseline test and during the experimental test
RMS value of the EMG signal	The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.	It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
EMG: Synchronisation of activation between muscle groups	It will assess in milliseconds the ability of the muscles to work in a synchronised manner.	It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
EMG: Activation ratio between upper and lower body muscles	RMS ratio between different muscles	It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
EMG: Median Frequency (MDF)	In the frequency domain, this median frequency of the EMG signal will be calculated.	It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
Balance	It will be assessed by Timed Up and Go Test (TUG) and Functional Reach Test (FRT)	Before the baseline test and after the experimental test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	It will be explored for measures of autonomic nervous system activation	It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
Respiratory Rate	It will be explored for measures of autonomic nervous system activation	It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
Analog Visual Scale	It will assess the feeling of unease after performing the baseline test and the experimental test respectively. The scale consists of a line from 0 (= totally relaxed) to 10 (=the most uneasy or restless feeling you have ever felt), which participants have to mark according to their feelings at that moment. Higher scores will correspond to a greater sense of unease.	Immediately after the baseline test and the experimental test respectively

Collaborators and Investigators

• Sponsor: University of Alcala
• Collaborators: European Union; Castilla-La Mancha Health Service
• Investigators: Principal Investigator: Susana N Núñez, PhD. Associate Professor, University of Alcalá; Principal Investigator: Bernardo A Alarcos, PhD. Full Professor, University of Alcalá

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CEIP/2023/5/110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No