HormonesNCT05022992
Effects of a Single Bout of Resistance Training Session on Hormonal Response in Pre-pubertal and Pubertal Boys
A study testing Resistance Training in people with Hormones and Cytokines, run by Umeå University at 1 site in Sweden.
Trial summary
: Resistance training induces strength gains in both children and adolescents. Exercise training is linked to anabolic functions through the GH-IGF-I axis. This has been demonstrated in studies showing a higher activity of GH and IGF-I in fitter adolescents and adults. Read more about this study
- Who is it for?
- Ages 9 to 17 years, men onlyHealthy volunteers can take part
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2021to Mar 2022
- 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 9 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy boys (n=40)
- Physically active, defined as a minimum of 2 years experience in a sports club
- Biological age range: 20 pre-pubertal (Tanner I-II) - 20 pubertal (Tanner III-IV) boys
- No previous experience of structured resistance training
Who cannot join
- Chronic diseases that affect full participation
- Injuries that limit full participation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå Movement and Exercise Laboratory, Umeå University
Umeå, Västerbotten County, 901 87
Apostolos Theos, PhD, +46702811565, apostolos.theos@umu.se
Tobias Stenlund, PhD, +46907868040, tobias.stenlund@umu.se
About this study
: Resistance training induces strength gains in both children and adolescents. Exercise training is linked to anabolic functions through the GH-IGF-I axis. This has been demonstrated in studies showing a higher activity of GH and IGF-I in fitter adolescents and adults. Exercise also stimulates pro-inflammatory cytokines (IL-1β, IL-6, TNF-α) that suppress the GH-IGF-I axis. This has been observed in endurance-type training, while resistance training has received less attention.
Boys experience a significant physiological muscle-growth change during puberty that is associated with increases in boys androgen levels. How maturation affects the hormonal response to resistance training in boys is unclear. Therefore, the purpose of the study is to compare the acute effects of a single bout of resistance training on hormones and pro-inflammatory cytokines in pre-pubertal and pubertal boys.
Read the detailed description
Preliminary measurements:
Preliminary testing will include anthropometric measurements of body mass, height, body fat percentage, and lean leg volume (LLV). The maturation stage will be determined according to the Tanner scale. There will also be an assessment of maximal strength testing to determine exercise intensity for each individual. Two familiarization sessions will be conducted for muscular strength before the muscular strength testing session.
Main trial A venous blood sample will be collected pre-exercise at resting condition. The trial will start with a standardized warm-up followed by a short (20-30 min), high-intensity whole-body resistance training session. Venous blood samples will be collected immediately after the completion of the training session and during the recovery period.
- Being tested
- Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Both groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Session | Experimental | Resistance training. Heavy resistance training. 10 reps x 3 set of upper- and lower-body resistance exercises Receives: Other: Resistance Training |
| Control | No intervention | Control activity. None-exercising. 30 min of rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Hormone Baseline
Blood Concentration of Growth Hormone
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Growth Hormone Post exercise
Blood Concentration of Growth Hormone
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Growth Hormone 15 minutes post exercise
Blood Concentration of Growth Hormone
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Growth Hormone 30 minutes post exercise
Blood Concentration of Growth Hormone
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Insulin-like Growth Factor-1 Baseline
Blood concentration of Insulin-like Growth Factor-1
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Insulin-like Growth Factor-1 Post exercise
Blood concentration of Insulin-like Growth Factor-1
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Insulin-like Growth Factor-1 15 minutes Post exercise
Blood concentration of Insulin-like Growth Factor-1
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Insulin-like Growth Factor-1 30 minutes Post exercise
Blood concentration of Insulin-like Growth Factor-1
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary outcomes (24)
Cortisol Baseline
Blood concentration of Cortisol
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Cortisol Post exercise
Blood concentration of Cortisol
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Cortisol 15 minutes Post exercise
Blood concentration of Cortisol
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Cortisol 30 minutes Post exercise
Blood concentration of Cortisol
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Testosterone Baseline
Blood concentration of testosterone
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Testosterone Post Exercise
Blood concentration of testosterone
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Testosterone 15 minutes Post Exercise
Blood concentration of testosterone
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Testosterone 30 minutes Post Exercise
Blood concentration of testosterone
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Interleukin-6 Baseline
Blood concentration of Interleukin-6
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Interleukin-6 Post Exercise
Blood concentration of Interleukin-6
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Interleukin-6 15 minutes Post Exercise
Blood concentration of Interleukin-6
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Interleukin-6 30 minutes Post Exercise
Blood concentration of Interleukin-6
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Interleukin-1 alpha Baseline
Blood concentration of Interleukin-1 alpha
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Interleukin-1 alpha Post Exercise
Blood concentration of Interleukin-1 alpha
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Interleukin-1 alpha 15 minutes Post Exercise
Blood concentration of Interleukin-1 alpha
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Interleukin-1 alpha 30 minutes Post Exercise
Blood concentration of Interleukin-1 alpha
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Tumor Necrosis Factor alpha Baseline
Blood concentration of Tumor Necrosis Factor alpha
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Tumor Necrosis Factor alpha Post Exercise
Blood concentration of Tumor Necrosis Factor alpha
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Tumor Necrosis Factor alpha 15 minutes Post Exercise
Blood concentration of Tumor Necrosis Factor alpha
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Tumor Necrosis Factor alpha 30 minutes Post Exercise
Blood concentration of Tumor Necrosis Factor alpha
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Sex Hormone Binding Globulin Baseline
Blood concentration of Sex Hormone Binding Globulin
Measured: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Baseline Sex Hormone Binding Post Exercise
Blood concentration of Sex Hormone Binding Globulin
Measured: Right after the completion of the exercise intervention (Post values)
Change from Baseline Baseline Sex Hormone Binding 15 minutes Post Exercise
Blood concentration of Sex Hormone Binding Globulin
Measured: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Sex Hormone Binding Globulin 30 minutes Post Exercise
Blood concentration of Sex Hormone Binding Globulin
Measured: 30 minutes after the completion of the exercise intervention (Post-30 values)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
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 HormonesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apostolos Theos, Umeå University
- Investigators
- Apostolos Theos, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022992
- Sponsor's protocol ID
- 2020-03179
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansson D, Lundberg E, Rullander AC, Domellof M, Lindberg AS, Andersson H, Theos A. Hormonal and inflammatory responses in prepubertal vs. pubertal male children following an acute free-weight resistance training session. Eur J Appl Physiol. 2025 Feb;125(2):381-392. doi: 10.1007/s00421-024-05603-2. Epub 2024 Sep 11.
PubMed 39259397
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Bout of Resistance Training Session on Hormonal Response in Pre-pubertal and Pubertal Boys
- ClinicalTrials.gov ID
- NCT05022992
- Acronym / sponsor ID
- 2020-03179
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 26 Aug 2021 (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.
: Resistance training induces strength gains in both children and adolescents. Exercise training is linked to anabolic functions through the GH-IGF-I axis. This has been demonstrated in studies showing a higher activity of GH and IGF-I in fitter adolescents and adults. Exercise also stimulates pro-inflammatory cytokines (IL-1β, IL-6, TNF-α) that suppress the GH-IGF-I axis. This has been observed in endurance-type training, while resistance training has received less attention.
Boys experience a significant physiological muscle-growth change during puberty that is associated with increases in boys androgen levels. How maturation affects the hormonal response to resistance training in boys is unclear. Therefore, the purpose of the study is to compare the acute effects of a single bout of resistance training on hormones and pro-inflammatory cytokines in pre-pubertal and pubertal boys.
Detailed description
Preliminary measurements:
Preliminary testing will include anthropometric measurements of body mass, height, body fat percentage, and lean leg volume (LLV). The maturation stage will be determined according to the Tanner scale. There will also be an assessment of maximal strength testing to determine exercise intensity for each individual. Two familiarization sessions will be conducted for muscular strength before the muscular strength testing session.
Main trial A venous blood sample will be collected pre-exercise at resting condition. The trial will start with a standardized warm-up followed by a short (20-30 min), high-intensity whole-body resistance training session. Venous blood samples will be collected immediately after the completion of the training session and during the recovery period.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Session | Experimental | Other: Resistance TrainingResistance training. Heavy resistance training. 10 reps x 3 set of upper- and lower-body resistance exercises |
| Control | No intervention | –Control activity. None-exercising. 30 min of rest |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy boys (n=40)
- Physically active, defined as a minimum of 2 years experience in a sports club
- Biological age range: 20 pre-pubertal (Tanner I-II) - 20 pubertal (Tanner III-IV) boys
- No previous experience of structured resistance training
Key exclusion criteria (2 listed)
- Chronic diseases that affect full participation
- Injuries that limit full participation
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 |
|---|---|---|
| Resistance TrainingBoth groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises. | Other | Resistance Training Session |
Primary outcome
Growth Hormone Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Blood Concentration of Growth Hormone
Change from Baseline Growth Hormone Post exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Blood Concentration of Growth Hormone
Change from Baseline Growth Hormone 15 minutes post exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Blood Concentration of Growth Hormone
Change from Baseline Growth Hormone 30 minutes post exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Blood Concentration of Growth Hormone
Insulin-like Growth Factor-1 Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Blood concentration of Insulin-like Growth Factor-1
Change from Baseline Insulin-like Growth Factor-1 Post exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Blood concentration of Insulin-like Growth Factor-1
Change from Baseline Insulin-like Growth Factor-1 15 minutes Post exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Blood concentration of Insulin-like Growth Factor-1
Change from Baseline Insulin-like Growth Factor-1 30 minutes Post exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Blood concentration of Insulin-like Growth Factor-1
24 secondary outcomes
Cortisol Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Cortisol Post exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Cortisol 15 minutes Post exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Cortisol 30 minutes Post exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Testosterone Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Testosterone Post Exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Testosterone 15 minutes Post Exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Testosterone 30 minutes Post Exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Interleukin-6 Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Interleukin-6 Post Exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Interleukin-6 15 minutes Post Exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Interleukin-6 30 minutes Post Exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Interleukin-1 alpha Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Interleukin-1 alpha Post Exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Interleukin-1 alpha 15 minutes Post Exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Interleukin-1 alpha 30 minutes Post Exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Tumor Necrosis Factor alpha Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Tumor Necrosis Factor alpha Post Exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Tumor Necrosis Factor alpha 15 minutes Post Exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Tumor Necrosis Factor alpha 30 minutes Post Exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Sex Hormone Binding Globulin Baseline
Time frame: Baseline testing before the exercise intervention (Pre values)
Change from Baseline Baseline Sex Hormone Binding Post Exercise
Time frame: Right after the completion of the exercise intervention (Post values)
Change from Baseline Baseline Sex Hormone Binding 15 minutes Post Exercise
Time frame: 15 minutes after the completion of the exercise intervention (Post-15 values)
Change from Baseline Sex Hormone Binding Globulin 30 minutes Post Exercise
Time frame: 30 minutes after the completion of the exercise intervention (Post-30 values)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 39259397Jansson D, Lundberg E, Rullander AC, Domellof M, Lindberg AS, Andersson H, Theos A. Hormonal and inflammatory responses in prepubertal vs. pubertal male children following an acute free-weight resistance training session. Eur J Appl Physiol. 2025 Feb;125(2):381-392. doi: 10.1007/s00421-024-05603-2. Epub 2024 Sep 11.
- Individual participant dataSharing planned: No
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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.
Apostolos Theos, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Hormones and Cytokines, run by Umeå University 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Apostolos Theos, PhD (+46702811565, apostolos.theos@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth Hormone Baseline (time frame: Baseline testing before the exercise intervention (Pre values)). The study lists 8 primary outcomes in all. 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 NCT05022992, 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 26 Aug 2021.