Mitropoulos Alexandros, Gumber Anil, Crank Helen, Akil Mohammed, Klonizakis Markos
Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, S10 2BP, UK.
Centre for Health and Social Care Research, Sheffield Hallam University, Sheffield, UK.
Trials. 2018 Nov 21;19(1):647. doi: 10.1186/s13063-018-2980-1.
Raynaud's phenomenon is one of the first clinical manifestations observed in systemic sclerosis (SSc). This microvasculature disorder affects mostly the digits in over 95% of SSc patients, significantly affecting their health-related quality of life (HRQoL) and incurring higher hospital admissions and other healthcare costs. Exercise is known to improve both micro- and macrovascular function - aerobic exercise and resistance training, separately or combined, have been demonstrated to lead to significant vasculo-physiological improvements in conditions that present vasculopathy. However, the effects of a combined exercise programme on microcirculation in SSc patients has yet to be investigated. Therefore, the purpose of this study is to assess the effects of high-intensity interval training (HIIT) combined with circuit resistance training on the microvascular function in the digital area of SSc patients.
This will be a randomised controlled, feasibility trial with two arms, wherein 30 patients with SSc in receipt of medical treatment will be randomly assigned to usual care (medical treatment) or to a 12-week supervised exercise programme. Patients in the exercise group will undertake two, 45-min sessions each week consisting of 30 min HIIT (30 s 100% peak power output/30 s passive recovery) on the arm crank ergometer and 15 min of upper body circuit resistance training. Patients will be assessed before as well as at 3 and 6 months following randomisation. Primary outcomes of the study will be recruitment and retention rate, intervention acceptability and adherence to the exercise programme. Secondary outcomes include the digital area cutaneous microvascular function (laser Doppler fluximetry combined with iontophoresis), physical fitness, functional ability, upper back transcutaneous oxygen tension, body composition and quality of life (EQ-5D-5L). Selected interviews with a subsample of patients will be undertaken to explore their experiences of having Raynaud's phenomenon and the acceptability of the exercise intervention and study procedures.
Data from this study will be used to identify the feasibility of a combined exercise programme to be implemented in SSc patients, the acceptability of the intervention and the study design, and to determine the effects of exercise on the microvasculature. Overall, this study will provide sufficient data to inform and support a full multicentre clinical trial.
ClinicalTrials.gov (NCT number): NCT03058887 , February 23, 2017.
雷诺现象是系统性硬化症（SSc）最早出现的临床表现之一。这种微血管疾病在超过95%的SSc患者中主要影响手指，严重影响他们的健康相关生活质量（HRQoL），并导致更高的住院率和其他医疗费用。已知运动可改善微血管和大血管功能——有氧运动和抗阻训练单独或联合使用，已被证明能在存在血管病变的情况下显著改善血管生理功能。然而，联合运动方案对SSc患者微循环的影响尚未得到研究。因此，本研究的目的是评估高强度间歇训练（HIIT）联合循环抗阻训练对SSc患者手指区域微血管功能的影响。
这将是一项双臂随机对照可行性试验，30名正在接受治疗的SSc患者将被随机分配到常规护理（药物治疗）组或为期12周的有监督运动方案组。运动组患者每周进行两次，每次45分钟的训练，包括在手臂曲柄测力计上进行30分钟的HIIT（30秒100%峰值功率输出/30秒被动恢复）和15分钟的上身循环抗阻训练。患者将在随机分组前以及随机分组后3个月和6个月进行评估。研究的主要结局将是招募和保留率、干预的可接受性以及对运动方案的依从性。次要结局包括手指区域皮肤微血管功能（激光多普勒血流仪结合离子导入法）、身体素质、功能能力、上背部经皮氧分压、身体成分和生活质量（EQ-5D-5L）。将对部分患者进行访谈，以探讨他们患雷诺现象的经历以及运动干预和研究程序的可接受性。
本研究的数据将用于确定在SSc患者中实施联合运动方案的可行性、干预和研究设计的可接受性，并确定运动对微血管系统的影响。总体而言，本研究将提供足够的数据，为全面的多中心临床试验提供信息和支持。
ClinicalTrials.gov（NCT编号）：NCT03058887，2017年2月23日。
