AmenorrheaNCT07612735
Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea
A study testing Resistance Training Program in people with Amenorrhea and Functional Hypothalamic Amenorrhea (FHA), run by Catholic University of Murcia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea, Functional Hypothalamic Amenorrhea (FHA), Low Energy Availability
- What is being tested?
- Resistance Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2026to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Amenorrhea, Functional Hypothalamic Amenorrhea (FHA), Low Energy Availability, Relative Energy Deficiency in Sport
- Being tested
- Resistance Training Program
- Medical subject headings
- Amenorrhea, Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont | Experimental | Not described Receives: Other: Resistance Training Program |
| Eumenorrheic women with regular ovulatory cycles (24-35 days) performing the same 8-week supervised | Experimental | Not described Receives: Other: Resistance Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (11)
Change in Neuromuscular Performance (Lower Limb Power)
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.
Measured: Baseline and 8 weeks
Change in Neuromuscular Performance (Upper Limb Power)
Evaluation of upper-limb strength through handgrip dynamometry testing. Grip strength (kg) was recorded to assess changes in maximal upper-limb force production.
Measured: Baseline and 8 weeks
Change in Body Mass
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.
Measured: Baseline and 8 weeks
Change in Fat Mass
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.
Measured: Baseline and 8 weeks
Change in Body Mass Index
Body mass index (BMI, kg/m²) will be calculated from body mass and height measurements to evaluate anthropometric changes following the intervention.
Measured: Baseline and 8 weeks
Change in Health-Related Quality of Life
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.
Measured: Baseline and 8 weeks
Pittsburgh Sleep Quality Index
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.
Measured: Baseline and 8 weeks
Low Energy Availability in Females Questionnaire
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).
Measured: Baseline and 8 weeks
Eating Attitudes Test
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.
Measured: Baseline and 8 weeks
Menstrual Distress Questionnaire
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.
Measured: Baseline and 8 weeks
Change in Cardiac Autonomic Regulation
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 May 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Daniela Quero Calero, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612735
- Sponsor's protocol ID
- CE052508
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29135914Cahoon 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.
PubMed 28368520
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Strength Training on Mental Health and Physical Fitness in Women With Functional Hypothalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT07612735
- Acronym / sponsor ID
- CE052508
- Conditions
- Amenorrhea, Functional Hypothalamic Amenorrhea (FHA), Low Energy Availability, Relative Energy Deficiency in Sport
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Catholic University of MurciaUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training ProgramSupervised 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. | Other | Eumenorrheic women with regular ovulatory cycles (24-35 days) performing the same 8-week supervised, Women with functional hypothalamic amenorrhea (absence of menses for at least three consecutive mont |
Primary outcome
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.
11 secondary outcomes
Change in Neuromuscular Performance (Lower Limb Power)
Time frame: Baseline and 8 weeks
Change in Neuromuscular Performance (Upper Limb Power)
Time frame: Baseline and 8 weeks
Change in Body Mass
Time frame: Baseline and 8 weeks
Change in Fat Mass
Time frame: Baseline and 8 weeks
Change in Body Mass Index
Time frame: Baseline and 8 weeks
Change in Health-Related Quality of Life
Time frame: Baseline and 8 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline and 8 weeks
Low Energy Availability in Females Questionnaire
Time frame: Baseline and 8 weeks
Eating Attitudes Test
Time frame: Baseline and 8 weeks
Menstrual Distress Questionnaire
Time frame: Baseline and 8 weeks
Change in Cardiac Autonomic Regulation
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 29135914Bunt 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.
- Background: PubMed 28368520Cahoon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Program in people with Amenorrhea and Functional Hypothalamic Amenorrhea (FHA), run by Catholic University of Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Menstrual Recovery (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07612735, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.