NCT05022992

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

June 11, 2021

Last Update Submit

August 20, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Growth Hormone Baseline

    Blood Concentration of Growth Hormone

    Baseline testing before the exercise intervention (Pre values)

  • Change from Baseline Growth Hormone Post exercise

    Blood Concentration of Growth Hormone

    Right after the completion of the exercise intervention (Post values)

  • 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)

  • 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)

  • Insulin-like Growth Factor-1 Baseline

    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

    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

    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

    Blood concentration of Insulin-like Growth Factor-1

    30 minutes after the completion of the exercise intervention (Post-30 values)

Secondary Outcomes (24)

  • Cortisol Baseline

    Baseline testing before the exercise intervention (Pre values)

  • Change from Baseline Cortisol Post exercise

    Right after the completion of the exercise intervention (Post values)

  • Change from Baseline Cortisol 15 minutes Post exercise

    15 minutes after the completion of the exercise intervention (Post-15 values)

  • Change from Baseline Cortisol 30 minutes Post exercise

    30 minutes after the completion of the exercise intervention (Post-30 values)

  • Testosterone Baseline

    Baseline testing before the exercise intervention (Pre values)

  • +19 more secondary outcomes

Study Arms (2)

Resistance Training Session

EXPERIMENTAL

Resistance training. Heavy resistance training. 10 reps x 3 set of upper- and lower-body resistance exercises

Other: Resistance Training

Control

NO INTERVENTION

Control activity. None-exercising. 30 min of rest

Interventions

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

Resistance Training Session

Eligibility Criteria

Age9 Years - 17 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic diseases that affect full participation
  • Injuries that limit full participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå Movement and Exercise Laboratory, Umeå University

Umeå, Västerbotten County, 901 87, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Apostolos Theos, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Apostolos Theos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2021

First Posted

August 26, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations