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Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea

22. května 2026 aktualizováno: Carmen Daniela Quero Calero, Catholic University of Murcia

Impact of Strength Training on Mental Health and Physical Fitness in Women With Functional Hypothalamic Amenorrhea

Functional hypothalamic amenorrhea (FHA) is a condition where women lose their menstrual periods, typically due to a combination of stress and insufficient calorie intake to fuel their daily physical activity (low energy availability). Standard medical advice often requires these women to completely stop exercising to recover their energy balance and hormones. However, this "complete rest" approach can cause severe anxiety for active individuals and removes the necessary mechanical loading that keeps bones strong.

This study evaluates the safety and effectiveness of an 8-week supervised resistance training (weightlifting) program as a realistic alternative treatment for active women with FHA. The researchers compare a group of women experiencing FHA to a control group of women with regular menstrual cycles. Over the 8 weeks, participants complete three moderate-intensity, full-body weightlifting sessions per week.

The primary goal is to determine if women with FHA can successfully recover their menstrual cycles while continuing to lift weights. Additionally, the study monitors changes in muscle strength, jumping performance, body composition, resting heart rate, and psychological well-being. Ultimately, this study aims to provide healthcare providers and coaches with evidence-based strategies that allow female athletes to safely maintain their athletic identity and physical health during recovery.

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

28

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Murcia
      • Murcia, Murcia, Španělsko, 30107
        • Universidad Católica de Murcia

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • General Profile: Active women aged 18 to 35 years.
  • FHA Group: Clinical diagnosis of Functional Hypothalamic Amenorrhea, defined as the absence of menstruation for at least three consecutive months not attributable to other endocrine disorders.
  • Control Group (EU): Eumenorrheic women with regular ovulatory cycles lasting between 24 and 35 days during the previous six months.
  • Commitment: Agreement to participate in a supervised 8-week resistance training program and provision of medical documentation confirming menstrual status.

Exclusion Criteria:

  • Hormonal Status: Current use of any hormonal contraceptives.
  • Medical Conditions: Diagnosed endocrine disorders such as Polycystic Ovary Syndrome (PCOS), hyperandrogenism, or thyroid dysfunction.

Pregnancy: Current pregnancy.

  • Physical Activity History: Engagement in any structured resistance training program during the three months prior to the start of the intervention.
  • General Health: Any medical condition that could interfere with the study protocol or the ability to perform physical exercise.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Women with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont

Supervised 8-week resistance training program consisting of three non-consecutive full-body sessions per week. Each session included four multi-joint exercises targeting upper and lower body muscle groups.

Training dosage:

Volume: Two working sets of 6-8 repetitions per exercise. Intensity: Individualized loads progressed weekly from 60% to 80% of estimated 1RM. 1RM was estimated using the Epley equation.

Effort: Performed at 0-1 repetitions in reserve (RIR). Rest:Standardized 1-minute intervals between sets.

Adherence was tracked via a mobile application, recording load, sets, repetitions, and session RPE. Training was conducted under professional supervision to ensure safety and protocol compliance.

Experimentální: Eumenorrheic women with regular ovulatory cycles (24-35 days) performing the same 8-week supervised

Supervised 8-week resistance training program consisting of three non-consecutive full-body sessions per week. Each session included four multi-joint exercises targeting upper and lower body muscle groups.

Training dosage:

Volume: Two working sets of 6-8 repetitions per exercise. Intensity: Individualized loads progressed weekly from 60% to 80% of estimated 1RM. 1RM was estimated using the Epley equation.

Effort: Performed at 0-1 repetitions in reserve (RIR). Rest:Standardized 1-minute intervals between sets.

Adherence was tracked via a mobile application, recording load, sets, repetitions, and session RPE. Training was conducted under professional supervision to ensure safety and protocol compliance.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Menstrual Recovery
Časové okno: 8 weeks
Number of participants in the Functional Hypothalamic Amenorrhea (FHA) group who experience at least one spontaneous menstrual bleeding episode during the 8-week intervention. Menstrual status is monitored daily using non-invasive methods: self-reported menstrual diaries and basal body temperature (BBT) tracking with a digital thermometer (SENTI2) to identify hormonal fluctuations. Recovery is defined as the occurrence of the first menses post-intervention commencement.
8 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Neuromuscular Performance (Lower Limb Power)
Časové okno: Baseline and 8 weeks
Evaluation of lower-limb power through the Countermovement Jump (CMJ) test performed on a force platform. Jump height (cm) and power output (W/kg) were recorded to assess neuromuscular adaptations.
Baseline and 8 weeks
Change in Neuromuscular Performance (Upper Limb Power)
Časové okno: Baseline and 8 weeks
Evaluation of upper-limb strength through handgrip dynamometry testing. Grip strength (kg) was recorded to assess changes in maximal upper-limb force production.
Baseline and 8 weeks
Change in Body Mass
Časové okno: Baseline and 8 weeks
Evaluation of body mass using bioelectrical impedance analysis. Body mass (kg) will be assessed before and after the intervention to monitor changes associated with menstrual recovery and the exercise intervention.
Baseline and 8 weeks
Change in Fat Mass
Časové okno: Baseline and 8 weeks
Evaluation of fat mass using bioelectrical impedance analysis. Fat mass (%) will be assessed before and after the intervention to determine body composition changes during menstrual recovery.
Baseline and 8 weeks
Change in Body Mass Index
Časové okno: Baseline and 8 weeks
Body mass index (BMI, kg/m²) will be calculated from body mass and height measurements to evaluate anthropometric changes following the intervention.
Baseline and 8 weeks
Change in Health-Related Quality of Life
Časové okno: Baseline and 8 weeks
Assessment of psychological well-being using the Short Form-36 (SF-36) questionnaire. This tool evaluates eight health domains, with total scores ranging from 0 to 100; higher scores indicate better health status and quality of life.
Baseline and 8 weeks
Pittsburgh Sleep Quality Index
Časové okno: Baseline and 8 weeks
A 19-item questionnaire generating seven component scores and one global score used to assess sleep quality. The global PSQI score ranges from 0 to 21 points, with higher scores reflecting poorer sleep quality. A global score >5 indicates poor sleep quality.
Baseline and 8 weeks
Low Energy Availability in Females Questionnaire
Časové okno: Baseline and 8 weeks
The Low Energy Availability in Females Questionnaire (LEAF-Q) is a 25-item instrument designed to assess risk factors associated with low energy availability in physically active females, including menstrual function, gastrointestinal symptoms, and injury history. The questionnaire provides a total score ranging from 0 to 25 points, with higher scores indicating greater risk of low energy availability and related conditions. A total score ≥8 is considered indicative of increased risk for low energy availability and the Female Athlete Triad/Relative Energy Deficiency in Sport (RED-S).
Baseline and 8 weeks
Eating Attitudes Test
Časové okno: Baseline and 8 weeks
The Eating Attitudes Test-26 (EAT-26) is a 26-item questionnaire assessing symptoms and concerns characteristic of eating disorders. It provides a total score and three subscales: dieting, bulimia and food preoccupation, and oral control. Total scores range from 0 to 78 points, with higher scores indicating greater disordered eating symptomatology. A total score ≥20 suggests potentially problematic eating behaviors and risk of eating disorders.
Baseline and 8 weeks
Menstrual Distress Questionnaire
Časové okno: Baseline and 8 weeks
The Menstrual Distress Questionnaire (MDQ) is a 22-item Likert-scale questionnaire designed to assess physical, psychological, and behavioral symptoms associated with the menstrual cycle. The questionnaire provides a total score ranging from 22 to 110 points, with higher scores indicating greater menstrual-related distress and symptom severity.
Baseline and 8 weeks
Change in Cardiac Autonomic Regulation
Časové okno: Baseline and 8 weeks
Assessment of heart rate variability (HRV) through the root mean square of successive differences between adjacent R-R intervals recorded via a heart rate monitor at rest.The following variables were obtained: mean R-R interval (RR, ms) and the root mean square of successive differences between adjacent R-R intervals (RMSSD, ms), to assess autonomic nervous system activity and cardiac autonomic modulation.
Baseline and 8 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

10. července 2026

Dokončení studie (Odhadovaný)

25. července 2026

Termíny zápisu do studia

První předloženo

15. května 2026

První předloženo, které splnilo kritéria kontroly kvality

22. května 2026

První zveřejněno (Aktuální)

29. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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