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Идёт набор NCT07391930

High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.

Без фазы С лечением Dysmenorrhea Primary Menstrual Pain Pelvic Pain

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: Supervised Online HIIT Program, Menstrual Health Workshop.
Кому может быть актуально
Состояния в реестре: Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain. Базовые параметры: 18 лет — 40 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
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Официальное название

Efficacy of a High-Intensity Interval Training Program and Analysis of Menstrual Health Experience in Women With Primary Dysmenorrhea: A Mixed-Methods Randomized Controlled Trial.

Обзор

The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.

Подробное описание

This research follows a convergent mixed-methods design integrating a randomized controlled trial with a descriptive qualitative study.

Fifty women (aged 18-40) with primary dysmenorrhea will be randomized into two arms:

Experimental Group: 12 weeks of online supervised HIIT (2 sessions/week) plus a menstrual health educational workshop.

Control Group: Menstrual health educational workshop only. Clinical variables (pain intensity via NRS, quality of life via SF-12, and pain characteristics via McGill Questionnaire) will be collected at baseline, 3 months (post-intervention), and 6 months (follow-up).

Simultaneously, all participants will complete a weekly semi-structured digital diary for 12 weeks. These diaries are designed to capture the "thick description" of their menstrual health experience, focusing on the evolution of their relationship with their body and menstruation, perceptions of self-management and empowerment and barriers and facilitators for adherence to the exercise program (in the experimental group).

Following the convergent design, quantitative statistical results will be integrated with the thematic analysis of the diaries. This merging of data will provide a holistic understanding of how high-intensity exercise influences not only physical symptoms but also the biopsychosocial perception of menstrual health in young women.

Вмешательства

  • Поведенческое Supervised Online HIIT Program
    The intervention consists of a total of 24 exercise sessions delivered over 12 weeks (frequency: 2 sessions per week). Each session is conducted online and supervised in real-time by a physical therapist. The 24 sessions follow a structured progression of high-intensity intervals, separated by active recovery periods.
  • Поведенческое Menstrual Health Workshop
    A 2-hour online educational session covering menstrual cycle physiology, pain neurophysiology, and self-care strategies. This intervention aims to improve menstrual health literacy and provide tools for pain self-management

Первичные конечные точки

  • Change in Menstrual Pain Intensity [Срок оценки: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)]
Вторичные конечные точки (5)
  • Health-Related Quality of Life [Срок оценки: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)]
  • Participant Menstrual Health Experience and Self-Management. [Срок оценки: Weekly during the 12-week intervention period]
  • Quality of Sleep [Срок оценки: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)]
  • Levels of Depression, Anxiety, and Stress [Срок оценки: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).]
  • Work Productivity and Activity Impairment [Срок оценки: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).]

Критерии участия

Критерии включения

  • nulliparous
  • primary dysmenorrhea
  • body mass index between 18 and 30
  • menstrual pain >5 according to the Numeric Pain Scale
  • exercise >45 minutes/week
  • understand Spanish and can freely read and sign the informed consent form

Критерии исключения

  • amenorrhea or cycles >35 days
  • secondary dysmenorrhea
  • pelvic or abdominal surgical intervention
  • use of hormonal drugs
  • diagnosed with fibromyalgia, muscoloskeletal injuries or medical comorbidities that prevent them from performing intense exercise
  • receiving physiotherapy for pelvic floor disorders
  • intense exercise >75 minutes/week

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia — Alcalá de Henares

Идентификаторы

NCT: NCT07391930 · EPP-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗