- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07692815
Sex-difference in Response to Resistance Exercise and Training (WOMENRESIST S1)
Sex-Difference in Response to Resistance Exercise and Training
Given the importance of muscular strength for athletic performance as well as for daily activities in the general population-including clinical populations-and the lack of data in both men and women, the aim of this study is to compare neuromuscular, intramuscular, and systemic adaptations in men and women in response to both acute and chronic resistance exercise.
Specifically, the investigators will test the hypotheses that:
the neuromuscular response to resistance exercise, including corticospinal excitability and motor unit activation patterns, differs between men and women; the hormonal response and exosome release following resistance exercise are reduced in women compared to men.
Participants (n = 15 per group) will follow a supervised resistance training program for 8 weeks. Neuromuscular function of the knee extensor muscles, body composition, intramuscular adaptations, as well as blood profiles (hormonal and metabolic) and exosomes will be assessed before and after a single resistance exercise session and after the training period. This protocol will allow determination of both the acute and long-term effects of resistance exercise.
Women's participation in sports is increasing, yet research in this area remains very limited. This project aims to better understand the mechanisms by which resistance training-a non-pharmacological and low-cost strategy-may induce different adaptations in men and women, and, where appropriate, to contribute to the development of sex-specific recommendations to maximize the health benefits of resistance training.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Enhet: Resistance exercise on a leg extension machine
- Enhet: Resistance training on a leg extension machine
- Fremgangsmåte: Blood samples
- Fremgangsmåte: Vastus lateralis biopsy
- Diagnostisk test: Body composition analysis
- Diagnostisk test: One repetition maximum (1-RM)
- Diagnostisk test: Muscle thickness of the vastus lateralis
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Louvain-la-Neuve, Belgia, 1348
- Faculté des sciences de la motricité, Pl. Pierre de Coubertin 1
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Men and women aged between 18 and 40 years;
- eumenorrheic women or under contraceptive (hormonal and non-hormonal).
Exclusion Criteria:
- Regular resistance exercise (≥2x/week);
- Any contraindication to exercise;
- Protein/creatine supplement intake;
- Pregnancy;
- Epilepsy;
- Head implant.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Men
Male participants performing a supervised 8-week resistance training program.
Neuromuscular, intramuscular, and systemic responses to both acute and chronic resistance exercise will be assessed.
|
Supervised resistance exercise consisting exclusively of knee extension exercise on a leg extension machine.
Acute exercise included 6 sets of 10 repetitions at 80% of one-repetition maximum (1RM).
Supervised resistance training consisting exclusively of knee extension exercise on a leg extension machine.
Chronic exercise included 6 sets of 10 repetitions at 80% of one-repetition maximum (1RM).
The program was carried out over 8 weeks (3x/week).
Blood samples were taken from the antecubital vein before and immediately after an acute resistance exercise session, and after the chronic resistance training period.
Biopsy were taken in the vastus lateralis before and immediately after an acute resistance exercise session, and after the chronic resistance training period.
Body composition analysis using dual-energy X-ray absorptiometry (DXA) before and after the chronic resistance training period.
One repetition maximum (1-RM) assessment before, after 4 weeks of training and at the end the chronic resistance training period.
Muscle thickness of the vastus lateralis assessed by ultrasonography before and after the chronic resistance training period.
|
|
Eksperimentell: Women
Female participants performing a supervised 8-week resistance training program.
Neuromuscular, intramuscular, and systemic responses to both acute and chronic resistance exercise will be assessed.
|
Supervised resistance exercise consisting exclusively of knee extension exercise on a leg extension machine.
Acute exercise included 6 sets of 10 repetitions at 80% of one-repetition maximum (1RM).
Supervised resistance training consisting exclusively of knee extension exercise on a leg extension machine.
Chronic exercise included 6 sets of 10 repetitions at 80% of one-repetition maximum (1RM).
The program was carried out over 8 weeks (3x/week).
Blood samples were taken from the antecubital vein before and immediately after an acute resistance exercise session, and after the chronic resistance training period.
Biopsy were taken in the vastus lateralis before and immediately after an acute resistance exercise session, and after the chronic resistance training period.
Body composition analysis using dual-energy X-ray absorptiometry (DXA) before and after the chronic resistance training period.
One repetition maximum (1-RM) assessment before, after 4 weeks of training and at the end the chronic resistance training period.
Muscle thickness of the vastus lateralis assessed by ultrasonography before and after the chronic resistance training period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sex differences in protein expression of muscle mass regulation pathways assessed by western blot
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of protein of expression muscle mass regulation pathways after acute exercise and chronic exercise using western blot (ratio of target protein to reference protein)
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in mRNA levels in muscle mass regulation pathways assessed by RT-qPCR
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of mRNA levels of muscle mass regulation pathways after acute exercise and chronic exercise usin RT-qPCR (fold change).
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in metabolic status assessed by blood biomarkers
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of metabolic blood parameters before and after acute exercise and chronic resistance training.
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in hormonal status assessed by blood biomarkers
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of hormonal blood parameters before and after acute exercise and chronic resistance training.
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in extracellular vesicles regulation assessed by nanoparticle tracking analysis
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of the concentration and size of circulating extracellular vesicles after acute exercise and chronic exercise using nanoparticle tracking analysis.
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in extracellular vesicles regulation assessed by proteomic analysis
Tidsramme: Throughout the entire study, during approximately 11 months
|
Assessment of protein expression of circulating extracellular vesicles after acute exercise and chronic exercise using proteomic analysis
|
Throughout the entire study, during approximately 11 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sex differences in body composition assessed by dual-energy X-ray absorptiometry (DXA)
Tidsramme: Throughout the entire study, during approximately 11 months
|
Comparison of fat mass and lean mass between men and women before and after the chronic resistance training.
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in muscle thickness of the vastus lateralis assessed by ultrasonography
Tidsramme: Throughout the entire study, during approximately 11 months
|
Comparison of vastus lateralis muscle thickness between men and women before and after the chronic resistance training.
|
Throughout the entire study, during approximately 11 months
|
|
Sex differences in strength evolution assessed by one-repetition maximum (1-RM)
Tidsramme: Throughout the entire study, during approximately 11 months
|
Comparison of maximal strength evolution between men and women before and after the chronic resistance training.
|
Throughout the entire study, during approximately 11 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sylvie Copine, Université Catholique de Louvain
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WOMENRESIST S1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .