School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
Physiotherapy Department, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.
Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.
We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1-2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge).
Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded.
Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible.
NCT02377830.
危重症患者的急性康复可以改善重症监护病房（ICU）后的身体功能。在患者 ICU 住院期间早期进行床上自行车运动是一种很有前途的干预措施。本研究的目的是确定一项多中心随机临床试验（RCT）中招募、干预实施和保留的可行性，该 RCT 对接受机械通气（MV）的患者进行早期床上自行车运动。
我们在加拿大的 7 个内科-外科 ICU 进行了一项先导性 RCT。我们招募了在 ICU 入院前可以独立行走、在接受有创性 MV 的前 4 天和 ICU 入院的前 7 天内的成年人。在获得知情同意后，患者接受了隐蔽性随机分组，分别接受每天 30 分钟的床上自行车运动和常规物理治疗（骑行）或单独接受常规物理治疗（常规），每周 5 天，直到 ICU 出院。我们的可行性结局目标包括：每月/每个站点招募 1-2 名患者；>80%的自行车运动方案实施；>80%的结局得到测量和>80%的出院时盲法结局测量。我们报告了主要试验（出院时 ICU 物理功能测试评分（PFIT-s））的主要结局的确定率。
在 2015 年 3 月至 2016 年 6 月期间，我们随机分配了 66 名患者（36 名骑行，30 名常规）。我们的同意率为 84.6%（66/78）。患者入组人数为（平均值（SD））1.1（0.3）例/每月/每个站点。有资格进行的 184 次骑行中，有 146 次（79.3%）进行了骑行，每次骑行的中位数（IQR）持续时间为 30.5（30.0，30.7）分钟。我们记录了 43 名（97.7%）PFIT-s 出院时的评分，其中 37 名（86.0%）的评估是盲法的。
我们的先导性 RCT 表明，对 ICU 中接受 MV 的患者进行早期床上自行车运动的多中心 RCT 是可行的。
NCT02377830。
