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Набор скоро начнётся NCT07612735

Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea

Без фазы С лечением Amenorrhea Functional Hypothalamic Amenorrhea (FHA) Low Energy Availability Relative Energy Deficiency in Sport

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Resistance Training Program.
Кому может быть актуально
Состояния в реестре: Amenorrhea, Functional Hypothalamic Amenorrhea (FHA), Low Energy Availability, Relative Energy Deficiency in Sport. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Вмешательства

  • Другое Resistance Training Program
    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 interv

Первичные конечные точки

  • Incidence of Menstrual Recovery [Срок оценки: 8 weeks]
Вторичные конечные точки (11)
  • Change in Neuromuscular Performance (Lower Limb Power) [Срок оценки: Baseline and 8 weeks]
  • Change in Neuromuscular Performance (Upper Limb Power) [Срок оценки: Baseline and 8 weeks]
  • Change in Body Mass [Срок оценки: Baseline and 8 weeks]
  • Change in Fat Mass [Срок оценки: Baseline and 8 weeks]
  • Change in Body Mass Index [Срок оценки: Baseline and 8 weeks]
  • Change in Health-Related Quality of Life [Срок оценки: Baseline and 8 weeks]
  • Pittsburgh Sleep Quality Index [Срок оценки: Baseline and 8 weeks]
  • Low Energy Availability in Females Questionnaire [Срок оценки: Baseline and 8 weeks]
  • Eating Attitudes Test [Срок оценки: Baseline and 8 weeks]
  • Menstrual Distress Questionnaire [Срок оценки: Baseline and 8 weeks]
  • Change in Cardiac Autonomic Regulation [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universidad Católica de Murcia — Murcia

Публикации

  • 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 29135914
  • 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/j PMID 28368520

Идентификаторы

NCT: NCT07612735 · CE052508

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗