NCT06245538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2025

Completed
Last Updated

December 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

January 28, 2024

Last Update Submit

November 24, 2025

Conditions

Keywords

FNIRSNeuroplasticityNeuroinflammationcerebral blood flowExercise intensityPsychological stress

Outcome Measures

Primary Outcomes (1)

  • Changes in cerebral blood flow in prefrontal cortex

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

    from before to after 20 minutes of exercise or seated rest

Secondary Outcomes (17)

  • Brain-derived neurotrophic factor

    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

    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

    At one time point at baseline

  • Platelet count

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

  • Cortisol

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

  • +12 more secondary outcomes

Study Arms (3)

Seated rest

EXPERIMENTAL

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

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)

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)

Behavioral: Exercise at vigorous intensity

Interventions

Seated restBEHAVIORAL

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

Seated rest

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

Exercise at moderate intensity

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

Exercise at vigorous intensity

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish School of Sport and Health Sciences

Stockholm, 11433, Sweden

Location

MeSH Terms

Conditions

Neuroinflammatory DiseasesStress, Psychological

Condition Hierarchy (Ancestors)

Nervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Maria Ekblom, PhD

    The Swedish School of Sport and Health Sciences (GIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The outcomes assessors follow standard operation procedures with automatic analyses and are blinded to study condition and individual stress ratings when analysing the collected data.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 7, 2024

Study Start

February 15, 2024

Primary Completion

October 6, 2025

Study Completion

October 21, 2025

Last Updated

December 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is no current plan to make individual participant data available to other researchers.

Locations