NCT07341165

Brief Summary

Satellite cells (SC) are muscle stem cells that once activated, proliferate, and differentiate into myocytes that finally fuse with an existing myofiber to regenerate or increase its mass. This process is called 'myogenesis'. Satellite cell activation can be modulated by exercise and by hypoxia. Hypoxia is a state of lower availability of oxygen that can be reached either by going at high altitude (hypobaric hypoxia) or by lowering the percentage of oxygen in hypoxic rooms at sea level. In opposition to the previously described systemic hypoxia, local hypoxia can be reached placing a cuff around a limb, which will induce a partial vascular occlusion. The latter is termed as blood flow restriction (BFR). In addition, in response to physical exercise, a local intramuscular hypoxia can be found back in the skeletal muscle. Myogenesis has been shown to be modulated by hypoxia in different ways, depending on the level of hypoxia: in conditions of mild hypoxia, satellite cell proliferation appears to be favorized, whereas SC differentiation is decreased in those conditions. In conditions of severe hypoxia, SC quiescence is promoted. SC activation increases in response to resistance training, with and without BFR. Some recent data also suggest that resistance exercise in hypoxic rooms may modulate SC activation, but this area is less well understood. Eccentric exercise may enhance SC activation in comparison to concentric contraction. Up to now, no study has analyzed SC activation and myogenesis in response to an eccentric exercise in hypoxia. Whereas macroscopic differences such as higher muscle force gains or hypertrophy, have been observed between normoxic and hypoxic resistance training, but could not be explained by the classical protein balance and growth factors, there is a need for a better understanding of the muscle response in hypoxia and several studies suggest a role of satellite cells and myogenesis in that difference. The purpose of this study is to elucidate whether or not satellite cells are regulated in a different way in response to an eccentric exercise in hypoxia comparing to normoxia. In addition, differences in SC activation between environmental normobaric hypoxia and BFR, two methods used to reach hypoxia at sea level, are not well understood yet. Finally, most of the studies evaluating myogenic response following a resistance exercise have only taken samples at two time-points, before and 24h after exercise in most of the cases. As the different steps of the myogenic process evolves over the days and may be enhanced or inhibited by hypoxic conditions, multiple time-points would be interesting to observe the evolution of the myogenic process. In that purpose, blood and skeletal muscle samples will be taken at different time-points to evaluate the progress of myogenesis following an acute eccentric exercise. Myogenic regulatory factors will be analyzed by RT-qPCR (mRNA), Western-Blot (protein) and immunofluorescence (localization). In addition, factors able to regulate myogenesis such as muscle damage, inflammation, growth factors, early-regulated genes, MAPK… will also be analyzed in order to understand if they play a role in response to hypoxic conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

December 19, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of markers of satellite cells and myogenesis

    Throughout the entire study, approximately during 30 months

Secondary Outcomes (1)

  • Comparison of the differences between exercise in environmental and local hypoxia

    Throughout the entire study, approximately during 30 months

Study Arms (3)

Resistance exercise in normoxia

ACTIVE COMPARATOR

Group that performed the resistance exercise in normoxia (FiO2=0.21)

Device: Resistance exercise on an isokinetic dynamometerProcedure: Vastus lateralis biopsyProcedure: Blood samplesDevice: Normoxia

Resistance exercise in hypoxia

EXPERIMENTAL

Group that performed the resistance exercise in hypoxia (FiO2=0.14)

Device: Resistance exercise on an isokinetic dynamometerProcedure: Vastus lateralis biopsyProcedure: Blood samplesDevice: Hypoxia

Resistance exercise with blood flow restriction

EXPERIMENTAL

Group that performed the resistance exercise with blood flow restriction (60%AOP)

Device: Resistance exercise on an isokinetic dynamometerProcedure: Vastus lateralis biopsyProcedure: Blood samplesDevice: Blood flow restriction

Interventions

Leg flexion/extension: 5 series of 15 repetitions at 60°/sec for the knee extension and 30°/sec for the knee flexion

Resistance exercise in hypoxiaResistance exercise in normoxiaResistance exercise with blood flow restriction

Biopsy taken in the vastus lateralis

Resistance exercise in hypoxiaResistance exercise in normoxiaResistance exercise with blood flow restriction
Blood samplesPROCEDURE

Blood samples taken from the antecubital vein

Resistance exercise in hypoxiaResistance exercise in normoxiaResistance exercise with blood flow restriction
NormoxiaDEVICE

Environmental condition for exercise: in a pressurized chamber with a inspired oxygen fraction of 0.21 (sea level)

Resistance exercise in normoxia
HypoxiaDEVICE

Environmental hypoxia: in a chamber where oxygen is extracted and replaced by nitrogen to reach an inspired oxygen fraction of 0.135 (equivalent to 2500m altitude)

Resistance exercise in hypoxia

Tourniquet placed around the proximal extremity of the lower limb and inflated at 60% of arterial occlusion pressure to induce local hypoxia

Resistance exercise with blood flow restriction

Eligibility Criteria

Age20 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy man
  • Aged between 20 and 49 years
  • Physically active
  • Not involved in resistance training,
  • No exposed to high altitude (\>1500m) 1 month before experiment

You may not qualify if:

  • Intake of AINS,
  • Illness with altered inflammatory status,
  • Condition that prohibits resistance exercise (muscle injury) or the sampling of tissue biopsies (aspirin, anticoagulants, allergy to lidocaine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté des Sciences de la Motricité

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Motor ActivityHypoxia

Interventions

Blood Specimen CollectionBlood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 14, 2026

Study Start

April 4, 2023

Primary Completion

May 8, 2023

Study Completion

September 5, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations