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Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea

22 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Murcia
      • Murcia, Murcia, Spagna, 30107
        • Universidad Católica de Murcia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Menstrual Recovery
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Neuromuscular Performance (Lower Limb Power)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

10 luglio 2026

Completamento dello studio (Stimato)

25 luglio 2026

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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