Clinical trial NCT06682754: Detection of Balance in the Elderly Under the Influence of Stress
Official title: Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Balance
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: European Union
name: Castilla-La Mancha Health Service
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Primary outcomes:
measure: Pressures on the floor
timeFrame: 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
measure: Triaxial accelerometry: acceleration and deceleration in object handling
timeFrame: 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
measure: RMS value of the EMG signal
timeFrame: 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
measure: EMG: Synchronisation of activation between muscle groups
timeFrame: 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
measure: EMG: Activation ratio between upper and lower body muscles
timeFrame: 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
measure: EMG: Median Frequency (MDF)
timeFrame: 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
measure: Balance
timeFrame: Before the baseline test and after the experimental test
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
measure: Respiratory Rate
timeFrame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
measure: Analog Visual Scale
timeFrame: Immediately after the baseline test and the experimental test respectively
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: University of Alcalá
Study officials:
affiliation: University of Alcalá
name: Susana N Núñez, PhD. Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alcalá
name: Bernardo A Alarcos, PhD. Full Professor
role: PRINCIPAL_INVESTIGATOR
References: