Chmelo Jakub, Phillips Alexander W, Greystoke Alastair, Charman Sarah J, Avery Leah, Hallsworth Kate, Welford Jenny, Cooper Matthew, Sinclair Rhona C F
Northern Oesophago-gastric unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE4 1LP, UK.
Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Pilot Feasibility Stud. 2022 Aug 9;8(1):173. doi: 10.1186/s40814-022-01137-6.
Treatment for locally advanced oesophagogastric adenocarcinoma involves neoadjuvant chemotherapy which has a negative impact on patient fitness. Using 'prehabilitation' to increase activity levels and fitness may affect physiology, postoperative outcomes and improve patient wellbeing and quality of life. The aims of the trial were to address the feasibility and acceptability of recruiting participants to a home-based prehabilitation programme and provide data to allow design of future studies.
We recruited patients to a single-arm feasibility trial of home-based exercise prehabilitation. Eligible patients were aged ≥18years, had operable oesophageal or gastric adenocarcinoma and were receiving neoadjuvant chemotherapy at our tertiary referral hospital. All participants commenced a home-based exercise programme utilising pedometers and step counting to target daily aerobic exercise sessions alongside daily strengthening exercises. A weekly telephone consultation directed the exercise programme and facilitated weekly data collection. The primary (feasibility) outcomes for the trial were (a) recruitment rate, (b) completion rate, (c) engagement with the programme (use of pedometers, recording step counts, telephone consultations) and (d) compliance with exercise sessions, exercise intensity and strengthening exercises.
There were 42 patients recruited, and the recruitment rate was 72.4% (42/58). 92.3% (36/39) of patients completed the exercise programme. There was 98.7% (IQR 93.2-100.0%) compliance with wearing a pedometer and recording data, and 100.0% (IQR 93.1-100.0%) compliance with a weekly telephone consultation. Exercise sessions and strengthening exercises were completed 70.2% (IQR 53.1-88.9%) and 69.4% (IQR 52.1-84.3%) of the time, respectively. Appropriate exercise intensity was recorded 96% (IQR 85.4-99.4%) of the time. There were no adverse events. Participants were enrolled in the exercise programme for a median of 91 days (IQR 84 to 105 days).
The results of this trial support the feasibility and acceptability of recruiting participants to an appropriately powered randomised controlled trial of prehabilitation.
Clinicaltrials.gov NCT04194463 . Registered on 11th December 2019-retrospectively registered.
局部晚期食管胃腺癌的治疗包括新辅助化疗,这对患者的身体状况有负面影响。采用“预康复”来提高活动水平和身体状况可能会影响生理机能、术后结果,并改善患者的幸福感和生活质量。该试验的目的是探讨招募参与者参加居家预康复计划的可行性和可接受性,并提供数据以便设计未来的研究。
我们招募患者参加一项居家运动预康复的单臂可行性试验。符合条件的患者年龄≥18岁,患有可手术的食管或胃腺癌,且在我们的三级转诊医院接受新辅助化疗。所有参与者都开始了一项居家运动计划,利用计步器和步数计数来设定每日有氧运动环节以及每日的强化锻炼。每周一次的电话咨询指导运动计划并促进每周的数据收集。该试验的主要(可行性)结局包括:(a)招募率,(b)完成率,(c)对计划的参与度(计步器的使用、步数记录、电话咨询),以及(d)对锻炼环节、锻炼强度和强化锻炼的依从性。
共招募了42名患者,招募率为72.4%(42/58)。92.3%(36/39)的患者完成了运动计划。佩戴计步器并记录数据的依从性为98.7%(四分位间距93.2 - 100.0%),每周电话咨询的依从性为100.0%(四分位间距93.1 - 100.0%)。锻炼环节和强化锻炼分别在70.2%(四分位间距53.1 - 88.9%)和69.4%(四分位间距52.1 - 84.3%)的时间内完成。适当锻炼强度的记录时间为96%(四分位间距85.4 - 99.4%)。未发生不良事件。参与者参加运动计划的中位时间为91天(四分位间距84至105天)。
该试验结果支持招募参与者参加一项有足够样本量的预康复随机对照试验的可行性和可接受性。
Clinicaltrials.gov NCT04194463。于2019年12月11日注册——回顾性注册。