NCT06682754 Detection of Balance in the Elderly Under the Influence of Stress
| NCT ID | NCT06682754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alcala |
| Condition | Balance |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-11-27 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Susana N Núñez, PhD. Associate Professor
PRINCIPAL INVESTIGATOR
University of Alcalá
Frequently Asked Questions
Who can join the NCT06682754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Balance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06682754 currently recruiting?
Yes, NCT06682754 is actively recruiting participants. Contact the research team at susana.nunez@uah.es for enrollment information.
Where is the NCT06682754 trial being conducted?
This trial is being conducted at Alcalá de Henares, Spain.
Who is sponsoring the NCT06682754 clinical trial?
NCT06682754 is sponsored by University of Alcala. The principal investigator is Susana N Núñez, PhD. Associate Professor at University of Alcalá. The trial plans to enroll 60 participants.