Detection of Balance in the Elderly Under the Influence of Stress
ConditionBalance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Alcala
About this trial
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
This trial accepts healthy volunteersQualifiers
Young adults (ages 18-39).
Older adults (≥65).
Voluntarily participate in the study.
Not meeting the
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Stress
Other interventionAll 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pressures on the floor
They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour
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 test2
Triaxial accelerometry: acceleration and deceleration in object handling
The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.
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 test3
RMS value of the EMG signal
The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.
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 test4
EMG: Synchronisation of activation between muscle groups
It will assess in milliseconds the ability of the muscles to work in a synchronised manner.
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 testSecondary outcomes
1
Heart Rate Variability
It will be explored for measures of autonomic nervous system activation
Time frame
It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test2
Respiratory Rate
It will be explored for measures of autonomic nervous system activation
Time frame
It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test3
Analog Visual Scale
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.
Time frame
Immediately after the baseline test and the experimental test respectivelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alcala
Lead sponsor
European Union
Collaborator
Castilla-La Mancha Health Service
Collaborator
Source ClinicalTrials.gov