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.
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
- Conditions the study is for
- Healthy Adults, Adults With Stress-related Symptoms
- What is being tested?
- Seated rest, Exercise at moderate intensity and Exercise at vigorous intensity
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Seated rest | Experimental | Participants will be resting while seated on a comfortable chair for 20 minutes Receives: Behavioral: Seated rest |
| Exercise at moderate intensity | Experimental | Participants 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 intensity | Experimental | Participants 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.
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)
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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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.
- First posted7 Feb 2024
- Study start15 Feb 2024
- Primary completion6 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Knowledge Foundation, Avonova, SATS - Sport Aerobic Trenings Senter, Itrim
- Responsible party
- Principal investigator, Maria Ekblom, The Swedish School of Sport and Health Sciences
- Investigators
- Maria Ekblom, PhD, Principal investigator, The Swedish School of Sport and Health Sciences (GIH)
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Physical Exercise of Different Intensities on Biological and Psychological Outcomes Under Subclinical Stress and in Health
- ClinicalTrials.gov ID
- NCT06245538
- Acronym / sponsor ID
- ExStress / 2022-07297-01
- Keywords
- FNIRS, Neuroplasticity, Neuroinflammation, cerebral blood flow, Exercise intensity, Psychological stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Collaborators
- The Knowledge Foundation, Avonova, SATS - Sport Aerobic Trenings Senter, Itrim
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Seated rest | Experimental | Behavioral: Seated restParticipants will be resting while seated on a comfortable chair for 20 minutes |
| Exercise at moderate intensity | Experimental | Behavioral: Exercise at moderate intensityParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max) |
| Exercise at vigorous intensity | Experimental | Behavioral: Exercise at vigorous intensityParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Medical contraindication to catheterization of the antecubital vein and blood sampling
- Dementia
- Alcohol abuse
- Smoking
- Chronic medication that is considered to affect study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seated restParticipants will be resting while seated on a comfortable chair for 20 minutes | Behavioural | Seated rest |
| Exercise at moderate intensityParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max) | Behavioural | Exercise at moderate intensity |
| Exercise at vigorous intensityParticipants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max) | Behavioural | Exercise at vigorous intensity |
Primary outcome
Changes in cerebral blood flow in prefrontal cortex
Time frame: from before to after 20 minutes of exercise or seated rest
working memory task-related changes in prefrontal cortex oxygenation measured using functional near-infrared spectroscopy
17 secondary outcomes
Brain-derived neurotrophic factor
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Working memory performance
Time frame: At one time point before and one time point after 20 minutes of exercise or seated rest (In total over 1 hour)
DNA allele of brain-derived neurotrophic factor
Time frame: At one time point at baseline
Platelet count
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Cortisol
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Epinephrine
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Norepinephrine
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
C-reactive protein (CRP)
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Interleukin 6 (IL-6)
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Tumor necrosis factor alpha (TNF-α)
Time frame: At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Mood
Time frame: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Mental fatigue
Time frame: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Physical fatigue
Time frame: At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
Sleep quality
Time frame: Over the night before and the night after each experimental session (In total over 36 hours)
Sleepiness
Time frame: At single time point before 20 minutes of exercise or seated rest
Heart rate variability
Time frame: Over the night before and the night after each experimental session (In total over 36 hours)
Augmentation index
Time frame: At a single time point at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. There is no current plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Ekblom, PhD principal investigator
The Swedish School of Sport and Health Sciences (GIH)
1 site in 1 country: see every site and its status.
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.