2型糖尿病(DM)是射血分数降低(HFrEF)的心力衰竭(HF)患者中最常见的合并症之一。关于混合综合远程康复(HCTR)对HFrEF患者与无糖尿病患者的心肺运动能力的疗效的数据有限。
本研究的目的是根据DM病史,分析9周HCTR与常规护理对HF患者心肺运动能力参数的影响。
在过去6个月内因HF恶化而住院后左心室射血分数[LVEF]<40%的临床稳定的HF患者被纳入TELEREH-HF(心力衰竭患者的TELEREHabilitation)试验,并随机分配到HCTR或常规护理(UC)。根据斜坡协议,在跑步机上进行心肺运动测试(CPET),增加工作量。
在385例HCTR组患者中进行了CPET:129例(33.5%)患有DM(HCTR-DM组),256例(66.5%)未患有DM(HCTR-非DM组)。在397名接受CPET的UC组患者中:137名(34.5%)患有DM(UC-DM组),260名(65.5%)没有DM(UC-非DM组)。在DM患者中,从基线到9周,HCTR和UC患者的心肺参数差异仍然相似.相比之下,在没有DM的患者中,在运动时间上,HCTR比UC与更大的9周变化相关,这导致患有和不患有DM的患者之间的统计学显着相互作用:HCTR与UC之间的运动时间变化差异在DM中为12.0s[95%CI-15.1,39.1s],在非DM中为43.1s[95%CI24.0,63.0s]。相互作用p值=0.016。此外,在休息通气中观察到DM和非DM之间HCTR与UC的影响的统计学显着差异:-0.34l/min[95%CI-1.60,0.91l/min]DM和0.83l/min[95%CI-0.06,1.73l/min]非DM,DM与DM的相互作用p值=0.0496,VE/VCO2斜率为:1.52[95%CI-1.55,4.59]-非DM为1.44[95%CI-3.64,0.77],相互作用p值=0.044。
混合综合远程康复与常规护理对改善身体表现的好处,与DM患者相比,无DM的HFrEF患者的通气特性和气体交换参数更为显著.
ClinicalTrials.gov标识符:NCT02523560。2015年8月3日注册。https://clinicaltrials.gov/ct2/show/NCT02523560?term=NCT02523560&draw=2&rank=1.其他研究ID号:STRATEGME1/233547/13/NCBR/2015。
Type 2 diabetes mellitus (DM) is one of the most common comorbidities among patients with heart failure (HF) with reduced ejection fraction (HFrEF). There are limited data regarding efficacy of hybrid comprehensive telerehabilitation (HCTR) on cardiopulmonary exercise capacity in patients with HFrEF with versus those without diabetes.
The aim of the present study was to analyze effects of 9-week HCTR in comparison to usual care on parameters of cardiopulmonary exercise capacity in HF patients according to history of DM.
Clinically stable HF patients with left ventricular ejection fraction [LVEF] < 40% after a hospitalization due to worsening HF within past 6 months were enrolled in the TELEREH-HF (The TELEREHabilitation in Heart Failure Patients) trial and randomized to the HCTR or usual care (UC). Cardiopulmonary exercise tests (CPET) were performed on treadmill with an incremental workload according to the ramp protocol.
CPET was performed in 385 patients assigned to HCTR group: 129 (33.5%) had DM (HCTR-DM group) and 256 patients (66.5%) did not have DM (HCTR-nonDM group). Among 397 patients assigned to UC group who had CPET: 137 (34.5%) had DM (UC-DM group) and 260 patients (65.5%) did not have DM (UC-nonDM group). Among DM patients, differences in cardiopulmonary parameters from baseline to 9 weeks remained similar among HCTR and UC patients. In contrast, among patients without DM, HCTR was associated with greater 9-week changes than UC in exercise time, which resulted in a statistically significant interaction between patients with and without DM: difference in changes in exercise time between HCTR versus UC was 12.0 s [95% CI - 15.1, 39.1 s] in DM and 43.1 s [95% CI 24.0, 63.0 s] in non-DM, interaction p-value = 0.016. Furthermore, statistically significant differences in the effect of HCTR versus UC between DM and non-DM were observed in ventilation at rest: - 0.34 l/min [95% CI - 1.60, 0.91 l/min] in DM and 0.83 l/min [95% CI - 0.06, 1.73 l/min] in non-DM, interaction p value = 0.0496 and in VE/VCO2 slope: 1.52 [95% CI - 1.55, 4.59] for DM vs. - 1.44 [95% CI - 3.64, 0.77] for non-DM, interaction p value = 0.044.
The benefits of hybrid comprehensive telerehabilitation versus usual care on the improvement of physical performance, ventilatory profile and gas exchange parameters were more pronounced in patients with HFrEF without DM as compared to patients with DM.
ClinicalTrials.gov Identifier: NCT02523560. Registered 3rd August 2015. https://clinicaltrials.gov/ct2/show/NCT02523560?term=NCT02523560&draw=2&rank=1 . Other Study ID Numbers: STRATEGME1/233547/13/NCBR/2015.