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Набор скоро начнётся NCT07626957

Hamstring Strengthening in Hypermobile Conditions

Без фазы С лечением Hypermobile EDS (hEDS) Hypermobile Ehlers-Danlos Syndrome Hypermobile Spectrum Disorder Hypermobility Type Ehlers-Danlos Syndrome

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: Progressive resistance exercise with an emphasis on eccentric hamstring loading..
Кому может быть актуально
Состояния в реестре: Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Hypermobility Type Ehlers-Danlos Syndrome. Базовые параметры: 18 лет — 55 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
Канада
Следующий шаг
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Официальное название

Effects and Feasibility of Eccentric Hamstring Strengthening in Hypermobility Spectrum Disorders and Hypermobile Ehlers-Danlos Syndrome

Обзор

The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). The main questions it aims to answer are: * Does hamstring strengthening reduce the looseness of the knee joint in HSD/hEDS? * Does hamstring strengthening improve clinical outcomes like pain in people living with HSD/hEDS? Participants will: * Attend two exercise classes per week for 12 weeks. * Visit the laboratory every 4-6 weeks for testing.

Подробное описание

Hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) affect 1 in 500 people, predominantly females. While exercise is known to be beneficial for HSD/hEDS, the effect of eccentric exercise on passive joint stability, the functional capacity to perform daily activities, and quality of life remains unknown. This clinical trial aims to determine the effects of a 12-week eccentric hamstring strengthening intervention for females with HSD/hEDS on knee joint laxity, performance during walking and stair climbing, and quality of life. This study will have important implications for understanding the impacts of exercise in HSD/hEDS. This can then inform clinical guidance and recommendations around lower limb exercise for this population.

Вмешательства

  • Поведенческое Progressive resistance exercise with an emphasis on eccentric hamstring loading.
    The exercise intervention consists of a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. This program is adapted from a lower limb progressive resistance training protocol that was well-tolerated and effective in people with HSD/hEDS. Each exercise session will start with a 10-minute aerobic warm up. This will be followed by the lower limb strengthening exercises, and a 5-minute aerobic cooldown. The lower limb exercises will include forward lunges and

Первичные конечные точки

  • Knee Joint Laxity [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
Вторичные конечные точки (8)
  • Knee Joint Stiffness [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Isokinetic eccentric knee flexion strength [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Isokinetic concentric knee flexion strength [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Hamstrings:Quadriceps Co-Activation [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • 6-Minute Walk Test [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Pain Severity Score [Срок оценки: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Safety of the Intervention [Срок оценки: Monitored throughout the study from baseline to 24 weeks.]
  • Tolerability of the Intervention [Срок оценки: Monitored throughout the study, from baseline to week 24.]

Критерии участия

Критерии включения

  • Reported diagnosis of HSD or hEDS by a physician
  • Meet the 2017 International Diagnostic Criteria for HSD and hEDS
  • Clearance to participant in exercise participation, determined using the Get Active Questionnaire

Критерии исключения

  • Other acquired or hereditary connective tissue disorder (i.e., rheumatoid arthritis, Marfan syndrome, etc.)
  • Currently experiencing daily knee pain
  • Prior knee injury or surgery
  • Intra-articular knee injection in the last 12 months
  • Currently pregnant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • University of Calgary - Foothills Campus — Calgary

Идентификаторы

NCT: NCT07626957 · REB26-0442

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗