Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF).
Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF).
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DOI：
10.1164/rccm.202106-1419oc
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发表时间：
2022-02-01
影响因子：
24.7
通讯作者：
ACTIVATE-CF Study Working Group
中科院分区：
文献类型：
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作者：
Hebestreit H;Kriemler S;Schindler C;Stein L;Karila C;Urquhart DS;Orenstein DM;Lands LC;Schaeff J;Eber E;Radtke T;ACTIVATE-CF Study Working Group
剧烈体力活动(PA)对囊性纤维化患者肺功能的长期影响尚不清楚。使用动机反馈评估为期12个月的部分监督PA干预的效果。在平行臂多中心随机对照试验(Activate-CF)中，年龄至少12岁的相对不活跃的患者被随机分配到干预组或对照组(1：1比)。干预组同意每周增加3小时的高强度PA，而对照组则被要求不改变PA行为。主要终点是6个月时预测FEV1的百分比(ΔFEV1)的变化。次要终点包括PA、运动能力、运动动机、首次恶化的时间和恶化率、生活质量、焦虑、抑郁、压力和血糖控制。使用混合线性模型对数据进行分析。共有117名患者(占目标样本量的40%)被随机分为干预组(n = 60例)和对照组(n = 57例)。6个月后，对照组ΔFEV1值显著高于干预组(2.70%预测值[95%可信区间0.13~5.26]；P = 0.04)。在每次研究访问时，干预组与对照组相比，精力充沛的PA增加，6个月和12个月的运动能力更高，12个月的PA更高。在其他次要结果中没有看到任何影响。Activate-CF增加了健壮的PA和运动能力，并持续了6个月，但对照组的FEV1更好。
The long-term effects of vigorous physical activity (PA) on lung function in cystic fibrosis are unclear. To evaluate effects of a 12-month partially supervised PA intervention using motivational feedback. In a parallel-arm multicenter randomized controlled trial (ACTIVATE-CF), relatively inactive patients aged at least 12 years were randomly assigned (1:1 ratio) to an intervention group or control group. The intervention group consented to add 3 hours of vigorous PA per week, whereas the control group was asked not to change their PA behavior. Primary endpoint was change in percent predicted FEV1 (ΔFEV1) at 6 months. Secondary endpoints included PA, exercise capacity, exercise motives, time to first exacerbation and exacerbation rates, quality of life, anxiety, depression, stress, and blood glucose control. Data were analyzed using mixed linear models. A total of 117 patients (40% of target sample size) were randomized to an intervention (n = 60) or control group (n = 57). After 6 months, ΔFEV1 was significantly higher in the control group compared with the intervention group (2.70% predicted [95% confidence interval, 0.13–5.26]; P = 0.04). The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months. No effects were seen in other secondary outcomes. ACTIVATE-CF increased vigorous PA and exercise capacity, with effects carried over for the subsequent 6 months, but resulted in better FEV1 in the control group.