Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These CellsNCT06484101
Functional Characterization of CD8+ T Cells After Supramaximal Exercise
A study testing Exercise in people with Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These Cells, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout. Read more about this study
- Who is it for?
- Ages 20 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These Cells
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2023to 14 Feb 2024
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be used to physical exercise and be able to perform strenous exercise Be able to attend the experimental procedure for the 90 minute duration of the study
Who cannot join
- Smoking Pregnant Have any medical condition requiring medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effekten av högintensiv träning på Vita Blodkroppar, Med Speciellt Fokus på Funktion Kopplad Till Att bekämpa Cancerceller
Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.
Read the detailed description
Healthy, human subjects perform 3 x 30 seconds of supramaximal exercise. Venous blood samples were obtained before and up to 60 minutes after the exercise bout. The blood was used for absolute count of lymphocytes and monocytes per volume blood, and for isolation of CD8+ T cells. It was also used for blood gas analysis. The CD8+ T cells were characterized using flow cytometry, and then cultured for 7 days with CD8+ activation beads. The cells were counted and analyzed for viability at day4 and day8. RNAseq was performed on CD8+ cells isolated before and directly after exercise. CD8+ T cells from Day 1 pre and post exercise and then after 7 days of culture, were analyzed for IFNgamma release using Elispot, and for cytotoxicity against HEK cancer cells in vitro. Flow cytometry of CD8+ T cells was performed on fresh CD8 T cells pre and post exercise, and then on day4 and day8 after culture. SeaHorse metabolic assay was done on Day1 CD8 T cells obtained pre and post exercise.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
3 x 30 seconds of supramaximal exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Healthy human subjects performing 3 x 30 seconds of supramaximal exercise with blood obtained before and up to 60 minutes after the exercise bout Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8 T cell absolute nr after exercise
CD8 nr
Measured: Before, directly after, 60 minutes after exercise
CD8 T cell cytotoxicity against cancer cells
CD8 T cell lysis of cancer cells
Measured: Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise
CD8 T cell pheontype after exercise
Flow cytometry analysis of CD8 T cells
Measured: Before, directly after, 30 minutes and 60 minutes after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start31 Mar 2023
- Primary completion22 Dec 2023
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These CellsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Rundqvist, Karolinska Institutet
- Investigators
- Helene Rundqvist, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484101
- Sponsor's protocol ID
- 2023-01066-01
- Other IDs
- 2023
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekten av högintensiv träning på Vita Blodkroppar, Med Speciellt Fokus på Funktion Kopplad Till Att bekämpa Cancerceller
- ClinicalTrials.gov ID
- NCT06484101
- Acronym / sponsor ID
- 2023-01066-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 3 Jul 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.
Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.
Detailed description
Healthy, human subjects perform 3 x 30 seconds of supramaximal exercise. Venous blood samples were obtained before and up to 60 minutes after the exercise bout. The blood was used for absolute count of lymphocytes and monocytes per volume blood, and for isolation of CD8+ T cells. It was also used for blood gas analysis. The CD8+ T cells were characterized using flow cytometry, and then cultured for 7 days with CD8+ activation beads. The cells were counted and analyzed for viability at day4 and day8. RNAseq was performed on CD8+ cells isolated before and directly after exercise. CD8+ T cells from Day 1 pre and post exercise and then after 7 days of culture, were analyzed for IFNgamma release using Elispot, and for cytotoxicity against HEK cancer cells in vitro. Flow cytometry of CD8+ T cells was performed on fresh CD8 T cells pre and post exercise, and then on day4 and day8 after culture. SeaHorse metabolic assay was done on Day1 CD8 T cells obtained pre and post exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Procedure: ExerciseHealthy human subjects performing 3 x 30 seconds of supramaximal exercise with blood obtained before and up to 60 minutes after the exercise bout |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Be used to physical exercise and be able to perform strenous exercise Be able to attend the experimental procedure for the 90 minute duration of the study
Key exclusion criteria (1 listed)
- Smoking Pregnant Have any medical condition requiring medical treatment
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 |
|---|---|---|
| Exercise3 x 30 seconds of supramaximal exercise | Procedure or surgery | Exercise |
Primary outcome
CD8 T cell absolute nr after exercise
Time frame: Before, directly after, 60 minutes after exercise
CD8 nr
CD8 T cell cytotoxicity against cancer cells
Time frame: Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise
CD8 T cell lysis of cancer cells
CD8 T cell pheontype after exercise
Time frame: Before, directly after, 30 minutes and 60 minutes after exercise
Flow cytometry analysis of CD8 T cells
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 3 Jul 2024.
- Individual participant dataSharing planned: No
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.
Helene Rundqvist, PhD principal investigator
Karolinska Institutet
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 Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These Cells, run by Karolinska Institutet 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 1 inclusion and 1 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 3 Jul 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 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?
CD8 T cell absolute nr after exercise (time frame: Before, directly after, 60 minutes after exercise). The study lists 3 primary outcomes in all. 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 3 Jul 2024.