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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05022992
Other study ID # 2020-03179
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date March 2022

Study information

Verified date August 2021
Source Umeå University
Contact Apostolos Theos, PhD
Phone +46702811565
Email apostolos.theos@umu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date March 2022
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 9 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Resistance Training
Both groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises.

Locations

Country Name City State
Sweden Umeå Movement and Exercise Laboratory, Umeå University Umeå Västerbotten

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth Hormone Baseline Blood Concentration of Growth Hormone Baseline testing before the exercise intervention (Pre values)
Primary Change from Baseline Growth Hormone Post exercise Blood Concentration of Growth Hormone Right after the completion of the exercise intervention (Post values)
Primary Change from Baseline Growth Hormone 15 minutes post exercise Blood Concentration of Growth Hormone 15 minutes after the completion of the exercise intervention (Post-15 values)
Primary Change from Baseline Growth Hormone 30 minutes post exercise Blood Concentration of Growth Hormone 30 minutes after the completion of the exercise intervention (Post-30 values)
Primary Insulin-like Growth Factor-1 Baseline Blood concentration of Insulin-like Growth Factor-1 Baseline testing before the exercise intervention (Pre values)
Primary Change from Baseline Insulin-like Growth Factor-1 Post exercise Blood concentration of Insulin-like Growth Factor-1 Right after the completion of the exercise intervention (Post values)
Primary Change from Baseline Insulin-like Growth Factor-1 15 minutes Post exercise Blood concentration of Insulin-like Growth Factor-1 15 minutes after the completion of the exercise intervention (Post-15 values)
Primary Change from Baseline Insulin-like Growth Factor-1 30 minutes Post exercise Blood concentration of Insulin-like Growth Factor-1 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Cortisol Baseline Blood concentration of Cortisol Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Cortisol Post exercise Blood concentration of Cortisol Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Cortisol 15 minutes Post exercise Blood concentration of Cortisol 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Cortisol 30 minutes Post exercise Blood concentration of Cortisol 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Testosterone Baseline Blood concentration of testosterone Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Testosterone Post Exercise Blood concentration of testosterone Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Testosterone 15 minutes Post Exercise Blood concentration of testosterone 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Testosterone 30 minutes Post Exercise Blood concentration of testosterone 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Interleukin-6 Baseline Blood concentration of Interleukin-6 Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Interleukin-6 Post Exercise Blood concentration of Interleukin-6 Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Interleukin-6 15 minutes Post Exercise Blood concentration of Interleukin-6 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Interleukin-6 30 minutes Post Exercise Blood concentration of Interleukin-6 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Interleukin-1 alpha Baseline Blood concentration of Interleukin-1 alpha Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Interleukin-1 alpha Post Exercise Blood concentration of Interleukin-1 alpha Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Interleukin-1 alpha 15 minutes Post Exercise Blood concentration of Interleukin-1 alpha 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Interleukin-1 alpha 30 minutes Post Exercise Blood concentration of Interleukin-1 alpha 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Tumor Necrosis Factor alpha Baseline Blood concentration of Tumor Necrosis Factor alpha Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Tumor Necrosis Factor alpha Post Exercise Blood concentration of Tumor Necrosis Factor alpha Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Tumor Necrosis Factor alpha 15 minutes Post Exercise Blood concentration of Tumor Necrosis Factor alpha 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Tumor Necrosis Factor alpha 30 minutes Post Exercise Blood concentration of Tumor Necrosis Factor alpha 30 minutes after the completion of the exercise intervention (Post-30 values)
Secondary Sex Hormone Binding Globulin Baseline Blood concentration of Sex Hormone Binding Globulin Baseline testing before the exercise intervention (Pre values)
Secondary Change from Baseline Baseline Sex Hormone Binding Post Exercise Blood concentration of Sex Hormone Binding Globulin Right after the completion of the exercise intervention (Post values)
Secondary Change from Baseline Baseline Sex Hormone Binding 15 minutes Post Exercise Blood concentration of Sex Hormone Binding Globulin 15 minutes after the completion of the exercise intervention (Post-15 values)
Secondary Change from Baseline Sex Hormone Binding Globulin 30 minutes Post Exercise Blood concentration of Sex Hormone Binding Globulin 30 minutes after the completion of the exercise intervention (Post-30 values)
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