- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245538
Exercise Intensity on Brain & Mental Health in Stress (ExStress)
Acute Effects of Physical Exercise of Different Intensities on Biological and Psychological Outcomes Under Subclinical Stress and in Health
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will include 43 adult (20 - 40 years) participants experiencing stress-related symptoms and 43 healthy controls, matched by age, sex, and fitness. It will be a matched-pair (individuals with stress-related symptoms versus matched healthy controls) 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 sessions, as well as for matching the two participant groups for fitness level. 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 seven time points: pre and post 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria M Ekblom, PhD
- Phone Number: +46 700039586
- Email: Maria.ekblom@gih.se
Study Contact Backup
- Name: Olga Tarassova, MSc
- Email: olga.tarassova@gih.se
Study Locations
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-
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Stockholm, Sweden, 11433
- The Swedish School of Sport and Health Sciences
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Contact:
- Maria M Ekblom, PhD
- Phone Number: +46 700039586
- Email: Maria.ekblom@gih.se
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Contact:
- Olga Tarassova, MSc
- Email: olga.tarassova@gih.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For participants both with and without stress-related symptoms:
- Age: 20-40 years
- Absence of contraindications to physical exercise
- Do not participate in any other study
For participants with stress-related symptoms:
• Total score on the self-assessment scale 4-factor Shirom-Melamed Burnout Measure-19 greater than or equal to 2.95 but lower than 4.00
For healthy controls:
• Total score on the self-assessment scale 4-factor SMBM-19 lower than or equal to 2.21
Exclusion Criteria:
For participants both with and without stress-related symptoms:
- 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
Exclusively for healthy controls:
• Depression (HAD depression score < 8) and anxiety (HAD anxiety score < 8)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Seated rest
Participants will be resting while seated on a comfortable chair for 20 minutes
|
Participants will be resting while seated on a comfortable chair for 20 minutes
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Experimental: Exercise at moderate intensity
Participants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max)
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Participants will perform a 20-min leg cycling exercise on a cycle ergometer at moderate intensity (60% of VO2max)
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Experimental: Exercise at vigorous intensity
Participants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max)
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Participants will perform a 20-min leg cycling exercise on a cycle ergometer at vigorous intensity (80% of VO2max)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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from before to after 20 minutes of exercise or seated rest
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
pro and mature BDNF in blood sample taken from the forearm antecubital vein; concentrations measured in blood plasma and serum
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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computerized working memory task (n-back: 1-, 2- and 3-back)
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At one time point before and one time point after 20 minutes of exercise or seated rest (In total over 1 hour)
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DNA allele of brain-derived neurotrophic factor
Time Frame: At one time point at baseline
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in blood sample taken before intervention from the forearm antecubital vein
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At one time point at baseline
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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)
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in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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biomarker of stress; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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biomarker of stress; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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biomarker of stress; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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as a measure of systemic inflammation; in blood sample taken from the forearm antecubital vein
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At three time points before and four time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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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)
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At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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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)
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At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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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)
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measured using Borg Rating of Perceived Exertion scale; scoring scale: from 6 (no exertion) to 20 (maximal exertion)
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At two time points before and two time points after 20 minutes of exercise or seated rest (In total over 2 hours)
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Sleep quality
Time Frame: Over the night before and the night after each experimental session (In total over 36 hours)
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measured using a Single-Item Sleep Quality Scale; scoring scale is from 0 (terrible) to 10 (excellent)
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Over the night before and the night after each experimental session (In total over 36 hours)
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Sleepiness
Time Frame: At single time point before 20 minutes of exercise or seated rest
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measured using Karolinska Sleepiness Scale; scoring scale is from 1 (extremely alert) to 9 (extremely sleepy)
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At single time point before 20 minutes of exercise or seated rest
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Heart rate variability
Time Frame: Over the night before and the night after each experimental session (In total over 36 hours)
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as an additional indicator of stress-related symptoms; measured with heart rate sensor and monitor
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Over the night before and the night after each experimental session (In total over 36 hours)
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Augmentation index
Time Frame: At a single time point at baseline
|
as a measure of arterial stiffness and indicator of cardiovascular health
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At a single time point at baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maria Ekblom, PhD, The Swedish School of Sport and Health Sciences (GIH)
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-07297-01
- 2023-08181-02 (Other Identifier: Swedish ethical review authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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