Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Trials. 2023 Jan 19;24(1):41. doi: 10.1186/s13063-022-07026-w.
This multicentre study explores the effects of pre-operative exercise on physical fitness, post-operative complications, recovery, and health-related quality of life in older individuals with low pre-operative physical capacity scheduled to undergo surgery for colorectal cancer. We hypothesise that this group of patients benefit from pre-operative exercise in terms of improved pre-operative physical function and lower rates of post-operative complications after surgery compared to usual care. Standardised cancer pathways in Sweden dictate a timeframe of 14-28 days from suspicion of cancer to surgery for colorectal cancer. Therefore, an exercise programme aimed to enhance physical function in the limited timeframe requires a high-intensity and high-frequency approach.
Participants will be included from four sites in Stockholm, Sweden. A total of 160 participants will be randomly assigned to intervention or control conditions. Simple randomisation (permuted block randomisation) is applied with a 1:1 allocation ratio. The intervention group will perform home-based exercises (inspiratory muscle training, aerobic exercises, and strength exercises) supervised by a physiotherapist (PT) for a minimum of 6 sessions in the pre-operative period, complemented with unsupervised exercise sessions in between PT visits. The control group will receive usual care with the addition of advice on health-enhancing physical activity. The physical activity behaviour in both groups will be monitored using an activity monitor. The primary outcomes are (1) change in physical performance (6-min walking distance) in the pre-operative period and (2) post-operative complications 30 days after surgery (based on Clavien-Dindo surgical score).
If patients achieve functional benefits by exercise in the short period before surgery, this supports the implementation of exercise training as a clinical routine. If such benefits translate into lower complication rates and better post-operative recovery or health-related quality of life is not known but would further strengthen the case for pre-operative optimisation in colorectal cancer.
ClinicalTrials.gov NCT04878185. Registered on 7 May 2021. https://clinicaltrials.gov/ct2/home.
本多中心研究旨在探讨术前运动对低术前体能的老年结直肠癌患者的身体适应性、术后并发症、恢复情况和健康相关生活质量的影响。我们假设，与常规护理相比，这些患者在术前身体功能改善和术后并发症发生率降低方面受益于术前运动。瑞典的标准化癌症途径规定，从怀疑癌症到结直肠癌手术的时间为 14-28 天。因此，旨在提高身体适应性的有限时间框架内的运动计划需要高强度和高频度的方法。
参与者将从瑞典斯德哥尔摩的四个地点入选。总共将有 160 名参与者随机分配到干预组或对照组。简单随机化（随机区组随机化），分配比例为 1:1。干预组将在术前期间由物理治疗师（PT）监督进行至少 6 次家庭运动（吸气肌训练、有氧运动和力量训练），并在 PT 就诊之间进行非监督运动。对照组将接受常规护理，并增加健康促进体力活动的建议。两组的身体活动行为都将使用活动监测器进行监测。主要结局是（1）术前期间身体表现（6 分钟步行距离）的变化，以及（2）术后 30 天的术后并发症（基于 Clavien-Dindo 手术评分）。
如果患者在手术前的短时间内通过运动获得功能上的益处，这将支持将运动训练作为一种临床常规实施。如果这些益处转化为较低的并发症发生率和更好的术后恢复或健康相关生活质量，目前尚不清楚，但将进一步加强结直肠癌术前优化的理由。
ClinicalTrials.gov NCT04878185。注册于 2021 年 5 月 7 日。https://clinicaltrials.gov/ct2/home.
