- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Apostolos Theos, PhD
- Numer telefonu: +46702811565
- E-mail: apostolos.theos@umu.se
Lokalizacje studiów
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Västerbotten
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Umeå, Västerbotten, Szwecja, 901 87
- Umeå Movement and Exercise Laboratory, Umeå University
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Kontakt:
- Apostolos Theos, PhD
- Numer telefonu: +46702811565
- E-mail: apostolos.theos@umu.se
-
Kontakt:
- Tobias Stenlund, PhD
- Numer telefonu: +46907868040
- E-mail: tobias.stenlund@umu.se
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Resistance Training Session
Resistance training.
Heavy resistance training.
10 reps x 3 set of upper- and lower-body resistance exercises
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Both groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises.
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Brak interwencji: Control
Control activity.
None-exercising.
30 min of rest
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Growth Hormone Baseline
Ramy czasowe: Baseline testing before the exercise intervention (Pre values)
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Blood Concentration of Growth Hormone
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Baseline testing before the exercise intervention (Pre values)
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Change from Baseline Growth Hormone Post exercise
Ramy czasowe: Right after the completion of the exercise intervention (Post values)
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Blood Concentration of Growth Hormone
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Right after the completion of the exercise intervention (Post values)
|
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Change from Baseline Growth Hormone 15 minutes post exercise
Ramy czasowe: 15 minutes after the completion of the exercise intervention (Post-15 values)
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Blood Concentration of Growth Hormone
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15 minutes after the completion of the exercise intervention (Post-15 values)
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Change from Baseline Growth Hormone 30 minutes post exercise
Ramy czasowe: 30 minutes after the completion of the exercise intervention (Post-30 values)
|
Blood Concentration of Growth Hormone
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30 minutes after the completion of the exercise intervention (Post-30 values)
|
|
Insulin-like Growth Factor-1 Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
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Change from Baseline Insulin-like Growth Factor-1 30 minutes Post exercise
Ramy czasowe: 30 minutes after the completion of the exercise intervention (Post-30 values)
|
Blood concentration of Insulin-like Growth Factor-1
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30 minutes after the completion of the exercise intervention (Post-30 values)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Cortisol Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
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Change from Baseline Testosterone 30 minutes Post Exercise
Ramy czasowe: 30 minutes after the completion of the exercise intervention (Post-30 values)
|
Blood concentration of testosterone
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30 minutes after the completion of the exercise intervention (Post-30 values)
|
|
Interleukin-6 Baseline
Ramy czasowe: Baseline testing before the exercise intervention (Pre values)
|
Blood concentration of Interleukin-6
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Baseline testing before the exercise intervention (Pre values)
|
|
Change from Baseline Interleukin-6 Post Exercise
Ramy czasowe: 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
Ramy czasowe: 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)
|
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Change from Baseline Interleukin-6 30 minutes Post Exercise
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 15 minutes after the completion of the exercise intervention (Post-15 values)
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Blood concentration of Interleukin-1 alpha
|
15 minutes after the completion of the exercise intervention (Post-15 values)
|
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Change from Baseline Interleukin-1 alpha 30 minutes Post Exercise
Ramy czasowe: 30 minutes after the completion of the exercise intervention (Post-30 values)
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Blood concentration of Interleukin-1 alpha
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30 minutes after the completion of the exercise intervention (Post-30 values)
|
|
Tumor Necrosis Factor alpha Baseline
Ramy czasowe: Baseline testing before the exercise intervention (Pre values)
|
Blood concentration of Tumor Necrosis Factor alpha
|
Baseline testing before the exercise intervention (Pre values)
|
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Change from Baseline Tumor Necrosis Factor alpha Post Exercise
Ramy czasowe: 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
Ramy czasowe: 15 minutes after the completion of the exercise intervention (Post-15 values)
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Blood concentration of Tumor Necrosis Factor alpha
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15 minutes after the completion of the exercise intervention (Post-15 values)
|
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Change from Baseline Tumor Necrosis Factor alpha 30 minutes Post Exercise
Ramy czasowe: 30 minutes after the completion of the exercise intervention (Post-30 values)
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Blood concentration of Tumor Necrosis Factor alpha
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30 minutes after the completion of the exercise intervention (Post-30 values)
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Sex Hormone Binding Globulin Baseline
Ramy czasowe: Baseline testing before the exercise intervention (Pre values)
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Blood concentration of Sex Hormone Binding Globulin
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Baseline testing before the exercise intervention (Pre values)
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Change from Baseline Baseline Sex Hormone Binding Post Exercise
Ramy czasowe: Right after the completion of the exercise intervention (Post values)
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Blood concentration of Sex Hormone Binding Globulin
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Right after the completion of the exercise intervention (Post values)
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Change from Baseline Baseline Sex Hormone Binding 15 minutes Post Exercise
Ramy czasowe: 15 minutes after the completion of the exercise intervention (Post-15 values)
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Blood concentration of Sex Hormone Binding Globulin
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15 minutes after the completion of the exercise intervention (Post-15 values)
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Change from Baseline Sex Hormone Binding Globulin 30 minutes Post Exercise
Ramy czasowe: 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)
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Apostolos Theos, PhD, Umeå University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2020-03179
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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