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NCT Number: NCT06682754

Detection of Balance in the Elderly Under the Influence of Stress

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.

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Key information

Conditions

Balance

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alcalá

Alcalá de Henares, Spain

Location status: Recruiting

Location contact

Susana N Núñez, PhD. Associate Professor

CONTACT

[email protected]

0034918852524

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress

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.

Primary outcomes

  1. Pressures on the floor

    Time frame: 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

    They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour

  2. Triaxial accelerometry: acceleration and deceleration in object handling

    Time frame: 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

    The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.

  3. RMS value of the EMG signal

    Time frame: 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

    The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.

  4. EMG: Synchronisation of activation between muscle groups

    Time frame: 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

    It will assess in milliseconds the ability of the muscles to work in a synchronised manner.

  5. EMG: Activation ratio between upper and lower body muscles

    Time frame: 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

    RMS ratio between different muscles

  6. EMG: Median Frequency (MDF)

    Time frame: 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

    In the frequency domain, this median frequency of the EMG signal will be calculated.

  7. Balance

    Time frame: Before the baseline test and after the experimental test

    It will be assessed by Timed Up and Go Test (TUG) and Functional Reach Test (FRT)

Secondary outcomes

  1. Heart Rate Variability

    Time frame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test

    It will be explored for measures of autonomic nervous system activation

  2. Respiratory Rate

    Time frame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test

    It will be explored for measures of autonomic nervous system activation

  3. Analog Visual Scale

    Time frame: Immediately after the baseline test and the experimental test respectively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susana N Núñez, PhD. Associate Professor

CONTACT

[email protected]

0034918852524

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Collaborators

  • Castilla-La Mancha Health Service
  • European Union

Registry information

Official study title

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

Acronym: DEPIE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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