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Healthy AdultsExStressNCT06245538

Exercise Intensity on Brain & Mental Health in Stress

A study testing Seated rest, Exercise at moderate intensity and Exercise at vigorous intensity in people with Healthy Adults and Adults With Stress-related Symptoms, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.

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

This study aims to examine the role of exercise intensity in the acute effects of a single bout of aerobic exercise on neurotrophic factors, biomarkers of stress and inflammation, working memory task-related changes in prefrontal cortex oxygenation in adults with sub-clinical levels of stress-related symptoms. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
What is being tested?
Seated rest, Exercise at moderate intensity and Exercise at vigorous intensity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSweden
Study dates
15 Feb 2024to 21 Oct 2025
Phase
Interventional
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 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants experiencing sub-clinical levels of stress-related symptoms:
  • Age: 20-40 years
  • Absence of contraindications to physical exercise
  • Do not participate in any other study
  • Total score on the self-assessment scale 4-factor Shirom-Melamed Burnout Measure-19 lower than or equal to 4.00

Who cannot join

  • Medical contraindication to catheterization of the antecubital vein and blood sampling
  • Dementia
  • Alcohol abuse
  • Smoking
  • Chronic medication that is considered to affect study outcomes
  • Chronic disease/syndrome such as migraine, fibromyalgia, chronic fatigue syndrome, bipolar syndrome, high blood pressure, cardiovascular disease, chronic obstructive pulmonary disease (COPD) or other lung disease
  • Post-COVID
  • Other somatic diseases, disorders, or injuries that may affect the physical ability during physical exercise

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • The Swedish School of Sport and Health Sciences

    Stockholm, 11433

Other trials in Sweden

About this study

Official title: Acute Effects of Physical Exercise of Different Intensities on Biological and Psychological Outcomes Under Subclinical Stress and in Health

This study aims to examine the role of exercise intensity in the acute effects of a single bout of aerobic exercise on neurotrophic factors, biomarkers of stress and inflammation, working memory task-related changes in prefrontal cortex oxygenation in adults with sub-clinical levels of stress-related symptoms.

Read the detailed description

This study initially set out to include 43 adult (20 - 40 years) participants experiencing stress-related symptoms and 43 healthy controls, matched by age, sex, and fitness. These procedures were approved by the Swedish Ethical Review Autority (Approval number 2022-07297-01 and 2023-08181-02). Due to recruitment difficulties the design was later changed to include all individuals with sub-clinical stress symptoms and using stress as a covariate instead of comparing groups of healthy and stressed individuals (Ethical review approval number 2025-01786-02). This is a randomized-order crossover experimental trial with three experimental conditions separated by a wash-out period of 7 days: 20-min leg cycling exercise at moderate intensity, 20-min leg cycling exercise at vigorous intensity, and 20-min seated rest (passive control condition).

Prior to entering the study, study inclusion/exclusion criteria will be controlled using digital screening. Before the experimental sessions, all participants will complete two introductory study visits. At the first introductory visit, the participant's maximal oxygen uptake (VO2max) will be determined using a fitness test. This information will be used to determine the individual workloads (% of individual VO2max) that the participant will be cycling at during the experimental session. At the second introductory visit, participants will complete a familiarization session, in which key methodological aspects of the study will be introduced to participants. Participants' augmentation index, as a measure of arterial stiffness, will also be completed during this visit.

In each of the three experimental sessions, participants will perform a computerized working memory task (n-back task) pre- and post-exercise (or seated rest). During the working memory task, functional near-infrared spectroscopy (fNIRS) will be used to measure task-related changes in prefrontal cortex oxygenation. As such, each participant will complete six fNIRS measurements, two measurements (pre, post) for each of the three experimental sessions (moderate, high, control). Simultaneous with the fNIRS measurements, blood flow velocity in the left and right middle cerebral artery will be assessed during the n-back tasks using Transcranial Doppler ultrasound. At each experimental session, blood will also be sampled from the antecubital vein at six time points: pre the first n-back task, pre and post the cycling exercise (or seated rest), pre and post the second n-back task, and post the final 10-min seated rest. Whole blood samples will be assessed for blood gases, acid-base status, electrolytes, hematocrit level, platelet count, and glucose. The separated blood plasma and serum samples will be used for measurements of neurotrophic factors, lactate, biomarkers of stress and inflammation, and factors involved in blood glucose control. Blood samples will also be used for targeted DNA screening for alleles of the BDNF.

Additionally, the participant's current mood, mental and physical fatigue, heart rate variability (HRV) and blood pressure will be assessed during four 10-min seated rest periods: pre and post n-back, and pre and post cycling exercise (or seated rest). Prior to each experimental study session, participants will have assessments of sleep quality the night before, current health status, physical activity level during the week prior to the test day, sleepiness level the last 10 min, and current mood. Participant's sleep quality and heart rate variability during the night before and after each experimental session will also be assessed.

A release of an updated version of this study was attempted prior to completion of the study on October 3 2025, but due to a shutdown of the US goverment this was not possible to register until in November 24 2025.

Being tested
Seated rest, Exercise at moderate intensity, Exercise at vigorous intensity
Keywords
FNIRS, Neuroplasticity, Neuroinflammation, cerebral blood flow, Exercise intensity, Psychological stress
Medical subject headings
Neuroinflammatory Diseases, Stress, Psychological

What participants receive

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

  • Seated restBehavioural

    Participants will be resting while seated on a comfortable chair for 20 minutes

  • Exercise at moderate intensityBehavioural

    Participants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max)

  • Exercise at vigorous intensityBehavioural

    Participants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max)

Study groups in NCT06245538
Study groupRoleWhat they receive
Seated restExperimentalParticipants will be resting while seated on a comfortable chair for 20 minutes
Receives: Behavioral: Seated rest
Exercise at moderate intensityExperimentalParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max)
Receives: Behavioral: Exercise at moderate intensity
Exercise at vigorous intensityExperimentalParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max)
Receives: Behavioral: Exercise at vigorous intensity

What is being measured

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

  1. Changes in cerebral blood flow in prefrontal cortex

    working memory task-related changes in prefrontal cortex oxygenation measured using functional near-infrared spectroscopy

    Measured: from before to after 20 minutes of exercise or seated rest

Secondary outcomes (17)
  1. Brain-derived neurotrophic factor

    pro and mature BDNF in blood sample taken from the forearm antecubital vein; concentrations measured in blood plasma and serum

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  2. Working memory performance

    computerized working memory task (n-back: 1-, 2- and 3-back)

    Measured: At one time point before and one time point after 20 minutes of exercise or seated rest (In total over 1 hour)

  3. DNA allele of brain-derived neurotrophic factor

    in blood sample taken before intervention from the forearm antecubital vein

    Measured: At one time point at baseline

  4. Platelet count

    in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  5. Cortisol

    biomarker of stress; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  6. Epinephrine

    biomarker of stress; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  7. Norepinephrine

    biomarker of stress; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  8. C-reactive protein (CRP)

    as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  9. Interleukin 6 (IL-6)

    as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  10. Tumor necrosis factor alpha (TNF-α)

    as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein

    Measured: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  11. Mood

    measured with a short version of Positive and Negative Affect Schedule (PANAS-SF) that include 5 positive and 5 negative affect states; the scoring scale is from 1 (very slightly or not at all) to 5 (extremely)

    Measured: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  12. Mental fatigue

    measured using Visual Analogue Scale (VAS-F); scoring scale: a line with 100 mm in length with scores falling between 0 mm (extremely alert) and 100 mm (extremely tired)

    Measured: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  13. Physical fatigue

    measured using Borg Rating of Perceived Exertion scale; scoring scale: from 6 (no exertion) to 20 (maximal exertion)

    Measured: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)

  14. Sleep quality

    measured using a Single-Item Sleep Quality Scale; scoring scale is from 0 (terrible) to 10 (excellent)

    Measured: Over the night before and the night after each experimental session (In total over 36 hours)

  15. Sleepiness

    measured using Karolinska Sleepiness Scale; scoring scale is from 1 (extremely alert) to 9 (extremely sleepy)

    Measured: At single time point before 20 minutes of exercise or seated rest

  16. Heart rate variability

    as an additional indicator of stress-related symptoms; measured with heart rate sensor and monitor

    Measured: Over the night before and the night after each experimental session (In total over 36 hours)

  17. Augmentation index

    as a measure of arterial stiffness and indicator of cardiovascular health

    Measured: At a single time point at baseline

Timeline

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

  1. First posted7 Feb 2024
  2. Study start15 Feb 2024
  3. Primary completion6 Oct 2025
  4. Study completion21 Oct 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized-order crossover experimental trial with three experimental conditions separated by a wash-out period of 7 days: 20-min leg cycling exercise at moderate intensity, 20-min leg cycling exercise at vigorous intensity, and 20-min seated rest (passive control condition)
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245538
Sponsor's protocol ID
2022-07297-01
Other IDs
2023-08181-02, 2023
Acronym
ExStress
Status last verified
Sep 2025
First submitted
28 Jan 2024
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no current plan to make individual participant data available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Seated rest, Exercise at moderate intensity and Exercise at vigorous intensity in people with Healthy Adults and Adults With Stress-related Symptoms, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.

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 5 inclusion and 8 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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?

Changes in cerebral blood flow in prefrontal cortex (time frame: from before to after 20 minutes of exercise or seated rest). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Dec 2025.

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