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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Visual Analogue Scale Nominated Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.
An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Intervention
Progressive high-load resistance training program performed twice weekly for 12 weeks
干预措施: High-load strength training for the knee (Other)
Standard care
The standard care group will receive instructions on a neuromuscular training program with focus on knee stability and function performed at low intensities to be conducted twice weekly for 12 weeks
干预措施: Neuromuscular training for the knee (Other)
结局指标
主要结局
Visual Analogue Scale Nominated Activity
时间窗: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months
The primary outcome is the Self-reported knee pain during an activity nominated by patients to be the most aggravating for their present knee pain (VAS nominated activity - VASNA, 0-100, 100 = worse). The primary endpoint is at 12-week follow-up.
次要结局
- Single-Leg-Hop for Distance(Baseline, 12 weeks)
- Dynamic knee strength(Baseline, 12 weeks)
- Adverse events(Up to 12 months)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 12 weeks, 12 months)
- Knee reposition sense(Baseline, 12 weeks)
研究者
Behnam Liaghat
Assistant Professor
University of Southern Denmark