Midtgaard Julie, Schnor Helle, Bjerre Eik D, Jespersen Tobias, Jelsøe Nina, Frølund Nanna, Seier Søren, Rønbøg Jacob W, Nordsborg Nikolai B, Ebdrup Bjørn H
Mental Health Centre Glostrup, University of Copenhagen, Nordstjernevej 41, DK-2600, Glostrup, Denmark.
Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, DK-2200, Copenhagen N, Denmark.
Pilot Feasibility Stud. 2021 Aug 19;7(1):162. doi: 10.1186/s40814-021-00900-5.
The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis.
Twenty-five patients with first-episode psychosis took part in a two-arm randomised feasibility trial. They were individually randomised (1:1) via a computer-generated randomisation sequence and allocated to either an exercise intervention group (INT) or a control group (CON). Patients allocated to INT completed a physical exercise training programme at moderate-to-vigorous intensity, 1 h three times weekly for 8 weeks. CON patients were encouraged to continue their usual level of activity and were offered the training programme after 8 weeks. Primary outcomes included screening rate, recruitment rate, retention rate, attendance and adverse events. Secondary outcomes included heart rate response during training, cardiovascular health (VO, resting heart rate, blood pressure), body composition (muscle mass, fat percentage), muscle strength (sit-to-stand, grip strength, jump height) and balance.
Recruitment lasted 6 weeks and 86 out of 324 patients (27%) were screened, 71 of whom (83%) were deemed eligible. Twenty-five (35%) accepted inclusion (mean age 25.5; mean body mass index 25.1) and were subsequently randomised (INT = 13, CON = 12). Retention of patients was 76% and 52% at the 8-week and 16-week follow-up, respectively. Attendance was 43% (min. 9%, max. 96%). No significant changes were observed between groups in secondary physiological outcome measures.
Feasibility was challenged by limited recruitment and retention rates, suggesting that modifications are required if a large-scale randomised controlled trial is to be conducted. Recommendations for modifications are presented and discussed.
Clinicaltrials.gov, NCT03409393 . Retrospectively registered.
本研究旨在探讨首发精神病患者试验流程及基于小组的结构化运动训练的可行性。
25例首发精神病患者参与了一项双臂随机可行性试验。通过计算机生成的随机序列将他们个体随机分组（1:1），并分配至运动干预组（INT）或对照组（CON）。分配至INT组的患者完成了一项中等至高强度的体育锻炼训练计划，每周3次，每次1小时，共8周。CON组患者被鼓励维持其日常活动水平，并在8周后提供该训练计划。主要结局包括筛查率、招募率、保留率、出勤率及不良事件。次要结局包括训练期间的心率反应、心血管健康（肺活量、静息心率、血压）、身体成分（肌肉量、脂肪百分比）、肌肉力量（从坐到站、握力、跳跃高度）及平衡能力。
招募持续了6周，324例患者中有86例（占27%）接受筛查评估，其中71例（占83%）被认为符合条件。25例（占35%）同意纳入研究（平均年龄25.5岁；平均体重指数25.1），随后被随机分组（INT组 = 13例，CON组 = 12例）。在8周和16周随访时，患者保留率分别为76%和52%。出勤率为43%（最低9%，最高96%）。两组间次要生理结局指标未观察到显著变化。
有限的招募率和保留率对可行性构成挑战，这表明若要开展大规模随机对照试验，需要进行改进。文中给出并讨论了改进建议。
Clinicaltrials.gov，NCT03409393。回顾性注册。
