Exercise in Patients With Hypermobile Joints and Knee Pain

Официальное название

High-load Resistance Training Compared With Usual Care for Treatment of Painful Knee Joint Hypermobility in Young Adults: A Randomised Controlled Trial (the HIPEr-Knee Study)

Обзор

Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Подробное описание

Knee joint hypermobility is common in the adult population. Patients with knee joint hypermobility and knee pain are typically managed with low intensity resistance training and proprioceptive training to reduce knee pain and improve function, but many patients do not respond well to these treatment strategies. High-load resistance training offers additional benefits to low intensity resistance training, including marked increase in muscle cross-sectional area, neural drive, and increased tendon stiffness, all important components of acquiring active knee joint stability during movement tasks and daily life. Therefore, the primary aim of this randomised controlled trial (RCT) is to investigate if high-load resistance training is superior to usual care in reducing activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Вмешательства

• Другое Neuromuscular training for the knee
  The exercise programme includes exercises identified in literature to target muscles around the knee.
• Другое High-load strength training for the knee
  The exercise programme includes exercises identified in literature to target muscles around the knee.

Первичные конечные точки

• Visual Analogue Scale Nominated Activity [Срок оценки: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months]

Вторичные конечные точки (5)

• Knee injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Baseline, 12 weeks, 12 months]
• Adverse events [Срок оценки: Up to 12 months]
• Dynamic knee strength [Срок оценки: Baseline, 12 weeks]
• Knee reposition sense [Срок оценки: Baseline, 12 weeks]
• Single-Leg-Hop for Distance [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

• Persistent knee pain for ≥ 3 months (self-reported)
• Knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (VAS; 0=no pain and 100=worst imaginable pain) (self-reported)
• Generalised joint hypermobility assessed with the Five-Part Hypermobility Questionnaire (positive ≥ 2/5) (self-reported)
• Local knee joint hypermobility using the passive hyperextension of the knee in standing (positive > 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive > 10 degrees) (objectively measured)

Критерии исключения

• Diagnosed with patellar tendinopathy
• Pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability)
• Knee surgery within the past year
• Participation in regular structured resistance training within the past six months
• Inability to speak and understand Danish.
• All types of Ehlers-Danlos syndrome
• Other heritable connective tissue disorders such as Marfan syndrome, osteogenesis imperfecta, Loeys-Dietz syndrome, Stickler syndrome, skeletal dysplasias
• Autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; Chromosomal conditions such as Fragile X syndrome, Kabuki syndrome, Down syndrome
• Neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Physiotherapy Clinics Region of Southern Denmark — Odense
• University of Southern Denmark — Odense

Публикации

• Liaghat B, Bojsen-Moller J, Juul-Kristensen B, Henriksen P, Mohammadnejad A, Heiberg BD, Thorlund JB. High-load strength training compared with standard care treatment in young adults with joint hypermobility and knee pain: study protocol for a randomised controlled trial (the HIPEr-Knee study). BMJ Open. 2024 Oct 16;14(10):e090812. doi: 10.1136/bmjopen-2024-090812. PMID 39414294

Идентификаторы

NCT: NCT06277401 · RCT_hypermobile_knee

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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