HealthyNCT06638684
T Cell Responses to Various Levels of Exercise Stress
A study testing Exercise in people with Healthy, run by University of Kansas at 1 site in United States.
Trial summary
The objective of this project is to quantify the immunoendocrine response to acute stress events combining both physical and psychological challenges. This work will serve as a pilot project examining differential stress induction in response to exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2015to 12 May 2016
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active
- Between the ages of 18-40,
- Healthy
- Non-obese (BMI <28 kg/m2)
- Non-smoking
- Free of metabolic or cardiovascular diseases.
Who cannot join
- Unhealed Fractures
- Thrombophlebitis (blood clots)
- Recent Surgery (within the last three months)
- Recent Uncontrolled Bruising
- Osteomyelitis (acute or chronic bone infection)
- Myositis Ossificans (hardened scarring in muscle tissue of the thigh).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High- and Moderate-intensity Exercise on T Cell Function in Healthy Young Men
The objective of this project is to quantify the immunoendocrine response to acute stress events combining both physical and psychological challenges. This work will serve as a pilot project examining differential stress induction in response to exercise. Participants will have an instructor with prior military training lead a two-hour training session for 10 recreationally fit male volunteers. You will be randomly assigned to a high-intensity training group to participate in the "military style" training and a low-intensity training group who will participate in a low-intensity cardiovascular training protocol. Blood samples will be collected from you prior to and following the exercise session and these samples will be analyzed for endocrine measures as well as markers of immune function to include chemokines and cytokines.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- Immune, Cytokine, Flow Cytometry, Immunoendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Moderate-intensity, High-intensity
Subjects in the two groups preformed 90-100 minutes of exercise at different intensities.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity exercise | Active comparator | Subjects will participate in a 100 min bout of exercise led by an exercise physiologist doing the same exercises as the high-intensity group, but at a lower effort level. Exercise consists of of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates, but performed at a pace allowing for in-session recovery. Scheduled 5 min rests will be included at 30, 60, and 85 min and MI subjects will be similarly encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise. Receives: Other: Exercise |
| High intensity exercise | Experimental | Subjects in this group will participate in an exercise session that is representative of a training event experienced by cadets preparing for military competitions. All exercises will consist of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates; with rapidly occurring exercise transitions to prevent recovery. The exercise bout will last a total of 100 min. Scheduled 5 min rests will be inserted at 30, 60, and 85 min. During the scheduled rest periods, subjects will be encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell proliferation
Blood samples were collected using standard venipuncture technique. Blood samples were obtained at baseline, immediately post-exercise (0h), 1 hour post (1h), 4 hours (4h), and 6 hours (6h) post-exercise in heparin vacutainer tubes. Peripheral blood mononuclear cells (PBMC) were isolated using Ficoll-Paque PLUS density gradient centrifugation. Total T cells were purified from washed PBMC by E-rosetting. T cell proliferation was analyzed in response to co-stimulation through CD3+CD28 using plate-bound antibodies, or phytohaemagglutinin (PHA) treatment, or no simulation. Cells were incubated for 6 days at 37˚C in a humidified incubator with 5% CO2 and then analyzed by flow cytometry. Cells were analyzed by flow cytometry using anti-CD3-APC, and anti-CD152-PE antibodies immediately after CD3+ T cell isolation (0 h) and following 6 d in culture using an Accuri C6 flow cytometer.
Measured: 6.5 hours
Secondary outcomes (3)
Catecholamines (hormones)
Blood will be collected in a vial containing EDTA (6 ml) for analysis of catecholamines. Plasma for catecholamine (epinephrine and norepinephrine) analyses was obtained by centrifugation at 2000 g for 10 min at 4˚C. The supernatant was removed and stored at -80˚C until analysis. Catecholamine concentrations will be determined using BI-CAT ELISA kits and performed per the manufacturer's instructions. The samples were measured at 450 nm using a Synergy HT microplate reader. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise.
Measured: 6.5 hours
Complete Blood Count
Peripheral blood will be collected in a vial containing EDTA (6 ml) for analysis of complete blood counts (CBC). These vials will be sent to a commercial clinical laboratory (Quest Diagnostics) for the CBC measures. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise).
Measured: 6.5 hours
Cortisol
Blood will be collected in a vial containing EDTA (6 ml) for analysis of cortisol. These vials will be sent to a commercial clinical laboratory (Quest Diagnostics) for the cortisol measures. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise).
Measured: 6.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Feb 2015
- Primary completion12 May 2016
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Gallagher, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638684
- Sponsor's protocol ID
- STUDY00001969
- Other IDs
- ONR N000141410202
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Siedlik J, Deckert J, Dunbar A, Bhatta A, Gigliotti N, Chan M, Benedict S, Bubak M, Vardiman J, Gallagher P. Acute high-intensity exercise enhances T cell proliferation compared to moderate-intensity exercise. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0420.
PubMed 39947139
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High- and Moderate-intensity Exercise on T Cell Function in Healthy Young Men
- ClinicalTrials.gov ID
- NCT06638684
- Acronym / sponsor ID
- STUDY00001969
- Conditions
- Healthy
- Keywords
- Immune, Cytokine, Flow Cytometry, Immunoendocrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 15 Oct 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.
The objective of this project is to quantify the immunoendocrine response to acute stress events combining both physical and psychological challenges. This work will serve as a pilot project examining differential stress induction in response to exercise. Participants will have an instructor with prior military training lead a two-hour training session for 10 recreationally fit male volunteers. You will be randomly assigned to a high-intensity training group to participate in the "military style" training and a low-intensity training group who will participate in a low-intensity cardiovascular training protocol. Blood samples will be collected from you prior to and following the exercise session and these samples will be analyzed for endocrine measures as well as markers of immune function to include chemokines and cytokines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise | Active comparator | Other: ExerciseSubjects will participate in a 100 min bout of exercise led by an exercise physiologist doing the same exercises as the high-intensity group, but at a lower effort level. Exercise consists of of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates, but performed at a pace allowing for in-session recovery. Scheduled 5 min rests will be included at 30, 60, and 85 min and MI subjects will be similarly encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise. |
| High intensity exercise | Experimental | Other: ExerciseSubjects in this group will participate in an exercise session that is representative of a training event experienced by cadets preparing for military competitions. All exercises will consist of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates; with rapidly occurring exercise transitions to prevent recovery. The exercise bout will last a total of 100 min. Scheduled 5 min rests will be inserted at 30, 60, and 85 min. During the scheduled rest periods, subjects will be encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Recreationally active
- Between the ages of 18-40,
- Healthy
- Non-obese (BMI <28 kg/m2)
- Non-smoking
Key exclusion criteria (6 listed)
- Unhealed Fractures
- Thrombophlebitis (blood clots)
- Recent Surgery (within the last three months)
- Recent Uncontrolled Bruising
- Osteomyelitis (acute or chronic bone infection)
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 |
|---|---|---|
| ExerciseAlso: Moderate-intensity, High-intensitySubjects in the two groups preformed 90-100 minutes of exercise at different intensities. | Other | High intensity exercise, Moderate intensity exercise |
Primary outcome
T cell proliferation
Time frame: 6.5 hours
Blood samples were collected using standard venipuncture technique. Blood samples were obtained at baseline, immediately post-exercise (0h), 1 hour post (1h), 4 hours (4h), and 6 hours (6h) post-exercise in heparin vacutainer tubes. Peripheral blood mononuclear cells (PBMC) were isolated using Ficoll-Paque PLUS density gradient centrifugation. Total T cells were purified from washed PBMC by E-rosetting. T cell proliferation was analyzed in response to co-stimulation through CD3+CD28 using plate-bound antibodies, or phytohaemagglutinin (PHA) treatment, or no simulation. Cells were incubated for 6 days at 37˚C in a humidified incubator with 5% CO2 and then analyzed by flow cytometry. Cells were analyzed by flow cytometry using anti-CD3-APC, and anti-CD152-PE antibodies immediately after CD3+ T cell isolation (0 h) and following 6 d in culture using an Accuri C6 flow cytometer.
3 secondary outcomes
Catecholamines (hormones)
Time frame: 6.5 hours
Complete Blood Count
Time frame: 6.5 hours
Cortisol
Time frame: 6.5 hours
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 15 Oct 2024.
- Derived from this study: PubMed 39947139Siedlik J, Deckert J, Dunbar A, Bhatta A, Gigliotti N, Chan M, Benedict S, Bubak M, Vardiman J, Gallagher P. Acute high-intensity exercise enhances T cell proliferation compared to moderate-intensity exercise. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0420.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Kansas at 1 site in United States.
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 6 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 15 Oct 2024. 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 United States. 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?
T cell proliferation (time frame: 6.5 hours). 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 NCT06638684, which also lists 1 linked publication.
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 15 Oct 2024.