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Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea

22 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

28

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
    • Murcia
      • Murcia, Murcia, Hiszpania, 30107
        • Universidad Católica de Murcia

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Women with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont
Inny: Resistance Training Program

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.
Eksperymentalny: Eumenorrheic women with regular ovulatory cycles (24-35 days) performing the same 8-week supervised
Inny: Resistance Training Program

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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Menstrual Recovery
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Neuromuscular Performance (Lower Limb Power)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Catholic University of Murcia

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2026

Zakończenie podstawowe (Szacowany)

10 lipca 2026

Ukończenie studiów (Szacowany)

25 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CE052508

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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