- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05022992
Effects of a Single Bout of Resistance Training Session on Hormonal Response in Pre-pubertal and Pubertal Boys
: 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Apostolos Theos, PhD
- Phone Number: +46702811565
- Email: apostolos.theos@umu.se
Study Locations
-
-
Västerbotten
-
Umeå, Västerbotten, Sweden, 901 87
- Umeå Movement and Exercise Laboratory, Umeå University
-
Contact:
- Apostolos Theos, PhD
- Phone Number: +46702811565
- Email: apostolos.theos@umu.se
-
Contact:
- Tobias Stenlund, PhD
- Phone Number: +46907868040
- Email: tobias.stenlund@umu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Chronic diseases that affect full participation
- Injuries that limit full participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Training Session
Resistance training.
Heavy resistance training.
10 reps x 3 set of upper- and lower-body resistance exercises
|
Both groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises.
|
|
No Intervention: Control
Control activity.
None-exercising.
30 min of rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth Hormone Baseline
Time Frame: Baseline testing before the exercise intervention (Pre values)
|
Blood Concentration of Growth Hormone
|
Baseline testing before the exercise intervention (Pre values)
|
|
Change from Baseline Growth Hormone Post exercise
Time Frame: Right after the completion of the exercise intervention (Post values)
|
Blood Concentration of Growth Hormone
|
Right after the completion of the exercise intervention (Post values)
|
|
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
|
15 minutes after the completion of the exercise intervention (Post-15 values)
|
|
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
|
30 minutes after the completion of the exercise intervention (Post-30 values)
|
|
Insulin-like Growth Factor-1 Baseline
Time Frame: Baseline testing before the exercise intervention (Pre values)
|
Blood concentration of Insulin-like Growth Factor-1
|
Baseline testing before the exercise intervention (Pre values)
|
|
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
|
Right after the completion of the exercise intervention (Post values)
|
|
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
|
15 minutes after the completion of the exercise intervention (Post-15 values)
|
|
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
|
30 minutes after the completion of the exercise intervention (Post-30 values)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortisol Baseline
Time Frame: Baseline testing before the exercise intervention (Pre values)
|
Blood concentration of Cortisol
|
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)
|
Blood concentration of Cortisol
|
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)
|
Blood concentration of Cortisol
|
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)
|
Blood concentration of Cortisol
|
30 minutes after the completion of the exercise intervention (Post-30 values)
|
|
Testosterone Baseline
Time Frame: Baseline testing before the exercise intervention (Pre values)
|
Blood concentration of testosterone
|
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)
|
Blood concentration of testosterone
|
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)
|
Blood concentration of testosterone
|
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)
|
Blood concentration of testosterone
|
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)
|
Blood concentration of Interleukin-6
|
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)
|
Blood concentration of Interleukin-6
|
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)
|
Blood concentration of Interleukin-6
|
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)
|
Blood concentration of Interleukin-6
|
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)
|
Blood concentration of Interleukin-1 alpha
|
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)
|
Blood concentration of Interleukin-1 alpha
|
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)
|
Blood concentration of Interleukin-1 alpha
|
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)
|
Blood concentration of Interleukin-1 alpha
|
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)
|
Blood concentration of Tumor Necrosis Factor alpha
|
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)
|
Blood concentration of Tumor Necrosis Factor alpha
|
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)
|
Blood concentration of Tumor Necrosis Factor alpha
|
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)
|
Blood concentration of Tumor Necrosis Factor alpha
|
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)
|
Blood concentration of Sex Hormone Binding Globulin
|
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)
|
Blood concentration of Sex Hormone Binding Globulin
|
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)
|
Blood concentration of Sex Hormone Binding Globulin
|
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)
|
Blood concentration of Sex Hormone Binding Globulin
|
30 minutes after the completion of the exercise intervention (Post-30 values)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Apostolos Theos, PhD, Umeå University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-03179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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