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A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study

机译:高产谱紊乱患者重型肩部加强运动的随机对照试验或高毛细管ehlers-Danlos综合征和持久肩部投诉:肩部MobileX学习的研究方案

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Four out of five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability. Evidence suggests that patients with HSD/hEDS who experience knee and back complaints improve with exercise-based therapy. However, no study has focused on exercise-based treatment for the shoulder in this patient group. The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability. The primary aim is to investigate the short-term effectiveness of a 16-week progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT), on self-reported shoulder symptoms, function, and quality of life. A superiority, parallel group, randomised controlled trial will be conducted with 100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3?months. Participants will be randomised to receive HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles. HEAVY will be supervised twice weekly, and LIGHT three times during the 16?weeks. The primary outcome will be between-group difference in change from baseline to 16-week follow-up in the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse). Secondary outcomes will include a range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception. Outcome assessors will be blinded to group allocation. Participants will be kept blind to treatment allocation through minimal information about the intervention content and hypotheses. Primary analyses will be performed by a blinded epidemiologist. If effective, the current heavy shoulder strengthening programme will challenge the general understanding of prescribing low-load exercise interventions for patients with HSD/hEDS and provide a new treatment strategy. The study will address an important and severe condition using transparent, detailed, and high-quality methods to potentially support a future implementation. ClinicalTrials.gov NCT03869307 . Registered on 11 March 2019.
机译:五个患者中有四名高能力谱系疾病(HSD)或高毛细管Ehlers-Danlos综合征(HEDS)经验肩部投诉,包括持续痛苦和不稳定。证据表明,随着基于运动的疗法,患有HSD / HED的HSD / HED患者的患者。然而,没有研究专注于在该患者组中的肩部进行基于运动的治疗。加强肩部肌肉的潜在益处,例如肌腱僵硬,患者患者可能对经常显示出低强度和肩部松弛/不稳定性的患者的HSD / HED患者有效。主要目的是调查16周的逐步重型肩部加强计划和一般建议(重)与低负担培训和一般建议(轻),以自我报告的肩部症状,功能和生活质量。优越性,平行组,随机对照试验将用100名从初级保健患者进行HSD / HED和肩部投诉(持续疼痛和/或不稳定),超过3个月。数月。参与者将随机分配以获得重大(全方位的运动,高负荷)或灯(中性到MOTION,低负载)加强计划,其次每周三次,锻炼瞄准肩胛骨袖口肌肉的练习。沉重将每周监督两次,并在16个周内轻三次。主要结果将在基准中的变化中的组差异与16周的肩膀不稳定指数(WOSI,0-2100更糟糕)的16周随访。除了肩部强度,松弛/不稳定性和预丙酸的临床测试之外,次要结果将包括涵盖症状,功能和生活质量的一系列自我报告的结果。结果评估员将被盲目地分配。参与者将通过有关干预内容和假设的最小信息对待遵守治疗分配。主要分析将由盲化流行病学家进行。如果有效,目前的重型肩部加强计划将挑战一般性地了解HSD / HEDS患者的低负担运动干预,并提供新的治疗策略。该研究将使用透明,详细和高质量方法来解决重要和严重的条件,以潜在支持未来的实施。 ClinicalTrials.gov NCT03869307。 2019年3月11日注册。

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