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Stress ReactionLIFT-UPNCT04530214

Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress

An observational study of Stress Reaction, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Stress Reaction
What is being tested?
Blood collection, Saliva collection and Electrocardiography (ECG)
How many people
20 participants
Where
4 sitesFrance
Study dates
4 Nov 2020to 10 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients admitted to the emergency room for a fracture of the upper end of the femur.

Who may be able to join

  • Fracture of the upper end of the femur
  • Cognitive state allowing the understanding of questionnaires

Who cannot join

  • Traumatic Brain Injury
  • Chronic inflammatory or immune pathologies
  • On anticoagulants
  • On neuroleptic or antidepressant treatment
  • Pathology or health condition not allowing 1-year survival

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU Pellegrin

    Bordeaux, 33000

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92140

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, 94163

  • Hôpital d'Instruction des Armées Sainte-Anne

    Toulon, 83800

Other trials in France

About this study

The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress is too intense or prolonged, response to stress may become misfitted and deleterious.

This study is based on the hypothesis that a severe physical or psychological trauma is associated with an intense and misfitted stress that is responsible from an undue immuno-inflammatory activation (through sympathetic activation). The result is a subinvasive state of systemic and tissue inflammation (low-noise inflammation), responsible for the mid-term deleterious consequences of the traumatic event.

Read more

The objective of this study is to understand how the dysregulation of intense stress simultaneously generates an initial pathological state and an alteration of mid-term evolution (which is considered as a poor prognosis and/or as responsible for after-effects).

The investigators wish to identify relevant biomarkers of the mechanisms activated during intense stress and influencing the immuno-inflammatory and epigenetic spheres with deleterious consequences on physiological and psychological functions.

Conditions
Stress Reaction
Being tested
Blood collection, Saliva collection, Electrocardiography (ECG), Questionnaires
Medical subject headings
Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collectionOther

    Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

  • Saliva collectionOther

    Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

  • Electrocardiography (ECG)Other

    Electrocardiography (ECG) at enrollment (24-72h following surgery) and at Visit 1 (45-60 days following surgery) to assess heart rate variability

  • QuestionnairesBehavioural

    Mental health assessment through questionnaires at enrollment (24-72h following surgery), at Visit 1 (45-60 days following surgery), at Visit 2 (7 months following surgery) and at Visit 3 (12 months following surgery)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of depression

    Screening for depression will be done using a validated self-report questionnaire, the Geriatric Depression Scale Short Version (GDS).

    We will use the threshold value of 10 (score > or =) which corresponds to a very high probability of depression.

    Measured: 12 months following surgery

  2. Occurrence of "psychosomatic death"

    The diagnosis of "psychosomatic death" will be made by a physician. There is no consensus on the diagnosis of this syndrome. However, a patient with "psychosomatic death" is likely to be hospitalized or followed up medically and will not be able to respond to the investigator's request for a telephone interview.

    Measured: 12 months following surgery

  3. Occurrence of death

    Vital status will be collected from the participant's family or referring physician or at the birth \& death record service (of the participant's town)

    Measured: 12 months following surgery

Secondary outcomes (16)

  1. Evolution of heart rate variability between enrollment and Visit 1

    Heart rate variability will be assessed using electrocardiography recordings

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  2. Evolution of perceived stress level between enrollment and Visit 1

    Perceived stress level will be assessed with the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  3. Evolution of anxiety level between enrollment and Visit 1

    Anxiety level will be assessed with the French version of Spielberger's State-Trait Anxiety Inventory adapted for people aged 65 and older (IASTA-Y65+).

    Individual scores on the IASTA-Y 65+ can range from 20 to 80 with higher scores indicating higher anxiety.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  4. Evolution of post-traumatic stress disorder severity level between enrollment and Visit 1

    Post-traumatic stress disorder severity will be assessed with the Post-traumatic stress disorder CheckList for DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine) (PCL-5) scale. Individual scores on the PCL-5 can range from 0 to 80 with higher scores indicating higher post-traumatic stress disorder severity.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  5. Evolution of quality of life between enrollment and Visit 1

    Quality of life will be assessed using the abbreviated version of the World Health Organization Quality of Life (WHOQOL-Bref).

    The WHOQOL-Bref is grouped into 4 domains :

    • Physical health (score range from 7 to 35)
    • Psychological health (score range from 6 to 30)
    • Social relationships (score range from 3 to 15)
    • Environment (score range from 8-40) Higher scores indicate higher quality of life.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  6. Evolution of cortisol level between enrollment and Visit 1

    Cortisol level will be measured in saliva sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  7. Evolution of GABA level between enrollment and Visit 1

    Gamma-aminobutyric acid (GABA) level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  8. Evolution of oxydative stress level between enrollment and Visit 1

    Oxydative stress level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  9. Evolution of BDNF level between enrollment and Visit 1

    Brain-derived neurotrophic factor (BDNF) level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  10. Evolution of pro and anti-inflammatory cytokines level between enrollment and Visit 1

    Cytokines level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  11. Evolution of IGF-1 level between enrollment and Visit 1

    Insulin like growth factor type 1 (IGF-1) will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  12. Evolution of NPY level between enrollment and Visit 1

    Neuropeptide Y (NPY) level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  13. Evolution of NPS between enrollment and Visit 1

    Neutrophil-platelet score (NPS) will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  14. Evolution of ocytocin level between enrollment and Visit 1

    Ocytocin level will be measured in blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  15. Evolution of methylation of genes coding for BDNF between enrollment and Visit 1

    Methylation of genes coding for BDNF will be measured on DNA extracted from blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

  16. Evolution of methylation of genes coding for glucocorticoid receptors between enrollment and Visit 1

    Methylation of genes coding for glucocorticoid receptors will be measured on DNA extracted from blood sample.

    Measured: Between enrollment and Visit 1 (45-60 days following surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start4 Nov 2020
  3. Primary completion10 Apr 2023
  4. Study completion10 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530214
Sponsor's protocol ID
2018PPRC30
Other IDs
2019-A01811-56
Acronym
LIFT-UP
Status last verified
Sep 2026
First submitted
25 Aug 2020
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Stress Reaction, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of depression (time frame: 12 months following surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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