Detection of Balance in the Elderly Under the Influence of Stress

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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,

Первичные конечные точки

• Pressures on the floor [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Before the baseline test and after the experimental test]

Вторичные конечные точки (3)

• Heart Rate Variability [Срок оценки: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test]
• Respiratory Rate [Срок оценки: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test]
• Analog Visual Scale [Срок оценки: Immediately after the baseline test and the experimental test respectively]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Испания · 1 центр

• University of Alcalá — Alcalá de Henares

Публикации

• Membership of GITES; Alarcos B, Diaz-Pulido B, Fernandez O, Fernandez-Guinea S, Garcia Herraiz A, Lendinez-Chica MDM, Martinez Muela J, Nunez-Nagy S, Perez-Martin Y, Rodriguez-Costa I, Rubio Gonzalez GM, Trapero-Asenjo S, Velasco JR. Detection of balance in the elderly under the influence of stress (DEPIE): A cross-sectional study protocol. PLoS One. 2026 Jan 27;21(1):e0341744. doi: 10.1371/journa PMID 41592138

Идентификаторы

NCT: NCT06682754 · CEIP/2023/5/110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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