Hasani Fatmah, Haines Terry P, Munteanu Shannon E, Vicenzino Bill, Malliaras Peter
Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Sciences, Monash University, Frankston, Victoria 3199 Australia.
Physiotherapy Department, Security Forces Hospital Program, Riyadh, 11481 Kingdom of Saudi Arabia.
Pilot Feasibility Stud. 2020 Jul 13;6:99. doi: 10.1186/s40814-020-00639-5. eCollection 2020.
Modifying variables in exercise prescription can produce specific effects on Achilles tendinopathy outcomes. This study aims to determine the feasibility of conducting an adequately powered randomised trial in the future to assess the efficacy of different load intensity and time-under-tension exercise parameters for improving pain and function in individuals with persistent midportion Achilles tendinopathy.
The trial is designed as prospective, four-armed feasibility and randomised pilot trial with 3 months follow-up. Interventions will be provided in a gym setting. The investigator, who will be blind to the allocation of participants, will conduct all pre- and post-intervention assessments. Forty-eight male participants with Achilles tendinopathy will be recruited from the community. We will use a 2 × 2 factorial design with factors of load intensity (six or eighteen repetitions maximum) and time-under-tension (two or six second repetitions). Participants will be randomised into one of the testing groups: six RM with two second repetitions, six RM with six second repetitions, eighteen RM with two second repetitions or eighteen RM with six second repetitions. Trial feasibility will be indicated by the rate of conversion, recruitment and retention, adherence to the interventions by participants, the utility of videoconferencing mode for weekly exercise supervision, incidence of adverse events, and feasibility of future economic evaluation. The secondary clinical outcomes will assess pain and disability, participant impression of change, satisfaction, health-related quality of life, physical activity, work absenteeism, psychological measures at baseline, 6 and 12 weeks, and plantarflexor contractile dysfunction (torque, rate of force development and muscle force steadiness) at baseline and 12 weeks. These clinical outcomes are primarily measured to provide information regarding potential treatment effects and trends.
The proposed study and follow-up powered randomised trial will be a first step towards determining exercise dose parameters that may optimise outcomes for Achilles tendinopathy. We have chosen to focus on load intensity and time-under-tension, as these parameters are important for tendon adaptation. This work has the potential to lead to more effective exercise loading interventions for Achilles tendinopathy.
Australian New Zealand Clinical Trials Registry, ACTRN12618001315202. Registered retrospectively on August 6th, 2018.
调整运动处方中的变量可对跟腱病的治疗结果产生特定影响。本研究旨在确定未来开展一项有足够效力的随机试验的可行性，以评估不同负荷强度和张力下时间的运动参数对改善持续性跟腱中部病变患者疼痛和功能的疗效。
该试验设计为前瞻性、四臂可行性随机试点试验，随访3个月。干预将在健身房环境中进行。对参与者分组不知情的研究者将进行所有干预前后的评估。将从社区招募48名患有跟腱病的男性参与者。我们将采用2×2析因设计，因素包括负荷强度（最大重复6次或18次）和张力下时间（每次重复2秒或6秒）。参与者将被随机分为以下测试组之一：6次最大重复量且每次重复2秒、6次最大重复量且每次重复6秒、18次最大重复量且每次重复2秒或18次最大重复量且每次重复6秒。试验可行性将通过转化率、招募率和保留率、参与者对干预措施的依从性、视频会议模式用于每周运动监督的效用、不良事件发生率以及未来经济评估的可行性来体现。次要临床结局将评估疼痛和残疾情况、参与者对变化的印象、满意度、健康相关生活质量、身体活动、工作缺勤情况、基线、6周和12周时的心理指标，以及基线和12周时的跖屈收缩功能障碍（扭矩、力量发展速率和肌肉力量稳定性）。测量这些临床结局主要是为了提供有关潜在治疗效果和趋势的信息。
拟议的研究及后续有足够效力的随机试验将是确定可能优化跟腱病治疗结果的运动剂量参数的第一步。我们选择关注负荷强度和张力下时间，因为这些参数对肌腱适应性很重要。这项工作有可能带来更有效的跟腱病运动负荷干预措施。
澳大利亚新西兰临床试验注册中心，ACTRN12618001315202。于2018年8月6日追溯注册。
