Clinical Trial

Detection of Balance in the Elderly Under the Influence of Stress

Study acronym: DEPIE
Recruiting
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Record status
This record was last updated August 7, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-08; most recent amendment 2025-08-06.
Status change: Not Yet Recruiting → Recruiting 2025-05-06
Trial Details
NCT Number NCT06682754
Lead Sponsor University of Alcala
Collaborators: European Union, Castilla-La Mancha Health Service
Conditions Balance
Enrollment 60 participants
Start Date 2024-11-27
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-08-07