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气功与运动/营养训练对女性癌症幸存者疲劳及其他结局影响的随机对照初步试验。

A Randomized Controlled Pilot Trial Comparing Effects of Qigong and Exercise/Nutrition Training on Fatigue and Other Outcomes in Female Cancer Survivors.

机构信息

Brown University, Department of Neuroscience, Providence, RI, USA.

Miriam Hospital, Women's Medicine Collaborative Lifestyle Medicine, Providence, RI, USA.

出版信息

Integr Cancer Ther. 2023 Jan-Dec;22:15347354231162584. doi: 10.1177/15347354231162584.

Abstract

Cancer-related fatigue (CRF) is a common and burdensome, often long-term side effect of cancer and its treatment. Many non-pharmacological treatments have been investigated as possible CRF therapies, including exercise, nutrition, health/psycho-education, and mind-body therapies. However, studies directly comparing the efficacy of these treatments in randomized controlled trials are lacking. To fill this gap, we conducted a parallel single blind randomized controlled pilot efficacy trial with women with CRF to directly compare the effects of Qigong (a form of mind-body intervention) (n = 11) to an intervention that combined strength and aerobic exercise, plant-based nutrition and health/psycho-education (n = 13) in a per protocol analysis. This design was chosen to determine the comparative efficacy of 2 non-pharmacologic interventions, with different physical demand intensities, in reducing the primary outcome measure of self-reported fatigue (FACIT "Additional Concerns" subscale). Both interventions showed a mean fatigue improvement of more than double the pre-established minimal clinically important difference of 3 (qigong: 7.068 ± 10.30, exercise/nutrition: 8.846 ± 12.001). Mixed effects ANOVA analysis of group × time interactions revealed a significant main effect of time, such that both groups significantly improved fatigue from pre- to post-treatment ((1,22) = 11.898,  = .002, generalized eta squared effect size = 0.116) There was no significant difference between fatigue improvement between groups (independent samples -test:  = .70 ), suggesting a potential equivalence or non-inferiority of interventions, which we could not definitively establish due to our small sample size. This study provides evidence from a small sample of n = 24 women with CRF that qigong improves fatigue similarly to exercise-nutrition courses. Qigong additionally significantly improved secondary measures of mood, emotion regulation, and stress, while exercise/nutrition significantly improved secondary measures of sleep/fatigue. These findings provide preliminary evidence for divergent mechanisms of fatigue improvement across interventions, with qigong providing a gentler and lower-intensity alternative to exercise/nutrition.

摘要

癌症相关疲劳(CRF)是癌症及其治疗的常见且负担沉重的长期副作用。许多非药物治疗已被研究为可能的 CRF 治疗方法,包括运动、营养、健康/心理教育和身心疗法。然而,直接比较这些治疗方法在随机对照试验中的疗效的研究尚缺乏。为了填补这一空白,我们对患有 CRF 的女性进行了一项平行的单盲随机对照试验,直接比较气功(一种身心干预形式)(n=11)与结合力量和有氧运动、植物性营养和健康/心理教育的干预(n=13)的效果,这是一种方案分析。这种设计是为了确定两种非药物干预措施的相对疗效,这两种干预措施具有不同的体力需求强度,以减少自我报告疲劳的主要结局测量(FACIT“其他关注点”子量表)。两种干预措施的平均疲劳改善都超过了预先确定的 3 个最小临床重要差异(气功:7.068±10.30,运动/营养:8.846±12.001)。组间时间交互作用的混合效应方差分析显示,时间有显著的主要影响,即两组均从治疗前到治疗后显著改善疲劳((1,22)=11.898,=0.002,广义 eta 平方效应大小=0.116)。两组之间的疲劳改善没有显著差异(独立样本-t 检验:=0.70),这表明干预措施具有潜在的等效性或非劣效性,由于我们的样本量小,我们无法明确确定。这项研究提供了来自 24 名患有 CRF 的女性的小样本证据,表明气功改善疲劳的效果与运动营养课程相似。气功还显著改善了次要的情绪、情绪调节和压力测量指标,而运动/营养则显著改善了次要的睡眠/疲劳测量指标。这些发现提供了干预措施改善疲劳的不同机制的初步证据,气功为运动/营养提供了一种更温和、低强度的替代方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a31a/10201164/c7e5bd2fd768/10.1177_15347354231162584-fig1.jpg

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