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NCT Number: NCT07612735

Effects of Resistance Training on 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica de Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance Training Program

Other

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.

Primary outcomes

  1. Incidence of Menstrual Recovery

    Time frame: 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.

Secondary outcomes

  1. Change in Neuromuscular Performance (Lower Limb Power)

    Time frame: 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.

  2. Change in Neuromuscular Performance (Upper Limb Power)

    Time frame: 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.

  3. Change in Body Mass

    Time frame: 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.

  4. Change in Fat Mass

    Time frame: 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.

  5. Change in Body Mass Index

    Time frame: 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.

  6. Change in Health-Related Quality of Life

    Time frame: 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.

  7. Pittsburgh Sleep Quality Index

    Time frame: 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.

  8. Low Energy Availability in Females Questionnaire

    Time frame: 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).

  9. Eating Attitudes Test

    Time frame: 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.

  10. Menstrual Distress Questionnaire

    Time frame: 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.

  11. Change in Cardiac Autonomic Regulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Catholic University of Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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