HealthyINHALENCT05826496
Exercise-induced Effects on Immune Parameters in Healthy Participants
A study testing Exercise in people with Healthy, run by Per thor Straten at 1 site in Denmark.
Trial summary
Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2023to 10 Feb 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have the ability to speak and read English and/or Danish.
- Agree to avoid alcohol, nonprescription drugs, and strenuous exercise for 24 hours prior VO2 max test and exercise intervention.
- Signed informed consent.
Who cannot join
- Autoimmune disease requiring active treatment.
- A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
- Use of medication known to affect the immune system (regular use of ibuprofen/aspirin or beta-blockers).
- Any systemic infections with fever within the last 4 weeks before the exercise intervention.
- Use of any illegal drugs (e.g., cocaine, amphetamine).
- Conditions with high risk for complications during exercise: Unstable medical disease, condition, or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Immunological Parameters in Blood from Healthy Participants Before and After High- to Moderate-intensity Aerobic Exercise
Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Therefore, the goal of this clinical study is to perform a comprehensive multi-parameter analysis of immunological parameters in healthy participants before and after one bout of high-intensity aerobic exercise. The primary endpoint of this study is to determine the exercise-induced changes of anti-viral T cell immunity in peripheral blood against common and recurrent viruses.
Up to 70 healthy participants in the age between 18 and 75 will be recruited. The first visit will be for prescreening the health status, answering questionnaires and providing a capillary blood sample for HLA screening. HLA-A2 positive participants will continue on the trial with a VO2 max test for Visit 2 and the supervised aerobic medium- to high-intensity (90% VO2 max) exercise session for Visit 3. Peripheral blood samples will be taken pre-exercise, within 2 minutes post-exercise and 60 minutes post-exercise.
These findings may pave the way to define serum markers or cellular immunological traits that provide new insight into how exercise promotes powerful and sustained cellular immune responses.
Read the detailed description
Numerous physiological parameters are influenced by exercise, including marked changes on numerous markers of the immune system. It has been shown that exercise lowers systemic low-grade inflammation, and there are indications that exercise improves the ability to combat infections and vaccination-induced immune responses.
Exercise has been repeatedly shown to mobilize immune cells into peripheral blood - most pronouncedly prototype killer cells of both the innate and adaptive immune system namely Natural Killer (NK) and T cells. Both cell types are critical in immune responses against viral infections and are also key effector cells in anti-cancer immune responses. Even more so, previously activated NK and T cells are selectively mobilized, potentially providing the background for exercise-mediated stronger anti-viral immunity.
In this study, the blood samples will be used to study global viral T cell reactivity against chronic [Cytomegalovirus (CMV) and Ebstein-Barr virus (EBV)] and recurrent [Influenza (flu) and SARS-CoV-2] viruses and detect their exact frequencies in peripheral blood. Since the technique is optimized for HLA*A2:01 positive individuals, this study will include a prescreening to match this tissue type. Adding more complexity to the acquired data, further analyses include but are not limited to phenotyping by CyTOF and flow cytometry as well as Luminex immune assays.
The current study will provide important insight into how the immune system is influenced by acute medium-to high-intensity exercise. These findings may have important implications for vaccine development, prevention in frail and at-risk populations, cancer prevention and cancer therapy.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- Acute exercise, Virus-specific T cells, High-intensity interval training, T cell, Acute stress response, NK cell, Inflammation, Exercise immunology, Catecholamines
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The supervised high-intensity interval training is conducted on bicycle ergometers at 85-95% maximal workload. The high-intensity interval sequences will be separated by two steady state sequences. Blood samples are collected at baseline, 2 min and 60 min post-exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | HLA-A2 positive participants will perform one bout of high-intensity interval training. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus-specific T cell responses
Investigate the number of virus-reactive CD8+ T cells at baseline, within 2 minutes after cessation and 60 minutes after cessation of the exercise bout in peripheral blood using DNA-barcoded peptide-MHC multimer assay.
Measured: 6 months
Secondary outcomes (2)
Phenotypes of exercise-mobilized immune cells
The investigators will assess the phenotype of immune cells in peripheral blood at baseline, within 2 minutes after cessation and 60 minutes after cessation of the exercise bout using Flow Cytometry and CyTOF.
Measured: 6 months
Circulating soluble markers
The investigators will analyse a panel of serum markers that reflect the effect of high-intensity exercise and its timely dynamics using Luminex and ELISA.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Mar 2023
- Primary completion31 Dec 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HLA-A2 positive participants complete one acute bout of supervised aerobic high-intensity exercise
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per thor Straten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per thor Straten, Herlev Hospital
- Investigators
- Gitte Holmen Olofsson, PhD, Principal investigator, CCIT, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826496
- Sponsor's protocol ID
- H-23006672
- Other IDs
- IN2301
- Acronym
- INHALE
- Status last verified
- Feb 2025
- First submitted
- 23 Mar 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leuchte K, Luu TV, Fresnillo Salo S, Madsen K, Heide-Ottosen L, Skadborg SK, Kemming JS, Holmstrom MO, Chen H, Olsen LR, Vinther A, Andersen MH, Hadrup SR, Thor Straten P, Holmen Olofsson G. Moving for optimal immunity: the effect of acute high-intensity interval training on phenotype, virus specificity and chemokine receptor expression in human CD8+ T cells. Front Immunol. 2026 Jan 19;16:1739657. doi: 10.3389/fimmu.2025.1739657. eCollection 2025.
PubMed 41675500Luu TV, Fleischer Hach L, Seremet T, Leuchte K, Thor Straten P, Holmen Olofsson G. Exercise Duration Modulates Cortisol Release and Chronic Cortisol Exposure Jeopardises T Cell Effector Functions. Immunology. 2026 Jan;177(1):94-105. doi: 10.1111/imm.70028. Epub 2025 Aug 12.
PubMed 40796353
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immunological Parameters in Blood from Healthy Participants Before and After High- to Moderate-intensity Aerobic Exercise
- ClinicalTrials.gov ID
- NCT05826496
- Acronym / sponsor ID
- INHALE / H-23006672
- Conditions
- Healthy
- Keywords
- Acute exercise, Virus-specific T cells, High-intensity interval training, T cell, Acute stress response, NK cell, Inflammation, Exercise immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Per thor StratenUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 24 Apr 2023 (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.
Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Therefore, the goal of this clinical study is to perform a comprehensive multi-parameter analysis of immunological parameters in healthy participants before and after one bout of high-intensity aerobic exercise. The primary endpoint of this study is to determine the exercise-induced changes of anti-viral T cell immunity in peripheral blood against common and recurrent viruses.
Up to 70 healthy participants in the age between 18 and 75 will be recruited. The first visit will be for prescreening the health status, answering questionnaires and providing a capillary blood sample for HLA screening. HLA-A2 positive participants will continue on the trial with a VO2 max test for Visit 2 and the supervised aerobic medium- to high-intensity (90% VO2 max) exercise session for Visit 3. Peripheral blood samples will be taken pre-exercise, within 2 minutes post-exercise and 60 minutes post-exercise.
These findings may pave the way to define serum markers or cellular immunological traits that provide new insight into how exercise promotes powerful and sustained cellular immune responses.
Detailed description
Numerous physiological parameters are influenced by exercise, including marked changes on numerous markers of the immune system. It has been shown that exercise lowers systemic low-grade inflammation, and there are indications that exercise improves the ability to combat infections and vaccination-induced immune responses.
Exercise has been repeatedly shown to mobilize immune cells into peripheral blood - most pronouncedly prototype killer cells of both the innate and adaptive immune system namely Natural Killer (NK) and T cells. Both cell types are critical in immune responses against viral infections and are also key effector cells in anti-cancer immune responses. Even more so, previously activated NK and T cells are selectively mobilized, potentially providing the background for exercise-mediated stronger anti-viral immunity.
In this study, the blood samples will be used to study global viral T cell reactivity against chronic [Cytomegalovirus (CMV) and Ebstein-Barr virus (EBV)] and recurrent [Influenza (flu) and SARS-CoV-2] viruses and detect their exact frequencies in peripheral blood. Since the technique is optimized for HLA*A2:01 positive individuals, this study will include a prescreening to match this tissue type. Adding more complexity to the acquired data, further analyses include but are not limited to phenotyping by CyTOF and flow cytometry as well as Luminex immune assays.
The current study will provide important insight into how the immune system is influenced by acute medium-to high-intensity exercise. These findings may have important implications for vaccine development, prevention in frail and at-risk populations, cancer prevention and cancer therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HLA-A2 positive participants complete one acute bout of supervised aerobic high-intensity exercise
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseHLA-A2 positive participants will perform one bout of high-intensity interval training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have the ability to speak and read English and/or Danish.
- Agree to avoid alcohol, nonprescription drugs, and strenuous exercise for 24 hours prior VO2 max test and exercise intervention.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Autoimmune disease requiring active treatment.
- A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
- Use of medication known to affect the immune system (regular use of ibuprofen/aspirin or beta-blockers).
- Any systemic infections with fever within the last 4 weeks before the exercise intervention.
- Use of any illegal drugs (e.g., cocaine, amphetamine).
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 |
|---|---|---|
| ExerciseThe supervised high-intensity interval training is conducted on bicycle ergometers at 85-95% maximal workload. The high-intensity interval sequences will be separated by two steady state sequences. Blood samples are collected at baseline, 2 min and 60 min post-exercise. | Other | Exercise |
Primary outcome
Virus-specific T cell responses
Time frame: 6 months
Investigate the number of virus-reactive CD8+ T cells at baseline, within 2 minutes after cessation and 60 minutes after cessation of the exercise bout in peripheral blood using DNA-barcoded peptide-MHC multimer assay.
2 secondary outcomes
Phenotypes of exercise-mobilized immune cells
Time frame: 6 months
Circulating soluble markers
Time frame: 1 year
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 12 Feb 2025.
- Derived from this study: PubMed 41675500Leuchte K, Luu TV, Fresnillo Salo S, Madsen K, Heide-Ottosen L, Skadborg SK, Kemming JS, Holmstrom MO, Chen H, Olsen LR, Vinther A, Andersen MH, Hadrup SR, Thor Straten P, Holmen Olofsson G. Moving for optimal immunity: the effect of acute high-intensity interval training on phenotype, virus specificity and chemokine receptor expression in human CD8+ T cells. Front Immunol. 2026 Jan 19;16:1739657. doi: 10.3389/fimmu.2025.1739657. eCollection 2025.
- Derived from this study: PubMed 40796353Luu TV, Fleischer Hach L, Seremet T, Leuchte K, Thor Straten P, Holmen Olofsson G. Exercise Duration Modulates Cortisol Release and Chronic Cortisol Exposure Jeopardises T Cell Effector Functions. Immunology. 2026 Jan;177(1):94-105. doi: 10.1111/imm.70028. Epub 2025 Aug 12.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Gitte Holmen Olofsson, PhD principal investigator
CCIT, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy, run by Per thor Straten at 1 site in Denmark.
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 3 inclusion and 6 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 12 Feb 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 Denmark. 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?
Virus-specific T cell responses (time frame: 6 months). 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 NCT05826496, which also lists 2 linked publications.
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 12 Feb 2025.