NCT07612735

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 15, 2026

Last Update Submit

May 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Menstrual Recovery

    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

Secondary Outcomes (11)

  • Change in Neuromuscular Performance (Lower Limb Power)

    Baseline and 8 weeks

  • Change in Neuromuscular Performance (Upper Limb Power)

    Baseline and 8 weeks

  • Change in Body Mass

    Baseline and 8 weeks

  • Change in Fat Mass

    Baseline and 8 weeks

  • Change in Body Mass Index

    Baseline and 8 weeks

  • +6 more secondary outcomes

Study Arms (2)

Women with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont

EXPERIMENTAL
Other: Resistance Training Program

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

EXPERIMENTAL
Other: Resistance Training Program

Interventions

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.

Eumenorrheic women with regular ovulatory cycles (24-35 days) performing the same 8-week supervisedWomen with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants aged over 18 years, including women with amenorrhea and eumenorrheic women, who have not previously engaged in strength training exercise prior to the interventio
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Murcia

Murcia, Murcia, 30107, Spain

Location

Related Publications (2)

  • Bunt S, Steverink N, Andrew MK, Schans CPV, Hobbelen H. Cross-Cultural Adaptation of the Social Vulnerability Index for Use in the Dutch Context. Int J Environ Res Public Health. 2017 Nov 14;14(11):1387. doi: 10.3390/ijerph14111387.

    PMID: 29135914BACKGROUND
  • Cahoon EK, Nadyrov EA, Polyanskaya ON, Yauseyenka VV, Veyalkin IV, Yeudachkova TI, Maskvicheva TI, Minenko VF, Liu W, Drozdovitch V, Mabuchi K, Little MP, Zablotska LB, McConnell RJ, Hatch M, Peters KO, Rozhko AV, Brenner AV. Risk of Thyroid Nodules in Residents of Belarus Exposed to Chernobyl Fallout as Children and Adolescents. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2207-2217. doi: 10.1210/jc.2016-3842.

    PMID: 28368520BACKGROUND

MeSH Terms

Conditions

AmenorrheaRelative Energy Deficiency in Sport

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 29, 2026

Study Start

May 15, 2026

Primary Completion

July 10, 2026

Study Completion

July 25, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations