- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07612735
Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Murcia
-
Murcia, Murcia, España, 30107
- Universidad Católica de Murcia
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Menstrual Recovery
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Neuromuscular Performance (Lower Limb Power)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CE052508
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .