DOI: 10.25442/hku.20174609.v1
title: Effectiveness of aerobic exercise and tai chi intervention on sleep disturbances in patients with advanced lung cancer: a multicentered three-arm randomized controlled trial

description: People with advanced lung cancer experience higher levels of symptom burden and psychological distress than other groups of cancer and the general population. In particular, patients with advanced lung cancer are prone to more sleep disturbance and daytime sleepiness than those of early stage. Sleep disturbances were found to interfere with the health-related quality of life. Due to the side effects and controversial long-term efficacy of pharmacological treatment, a substantial interest has arisen in non-pharmacological treatment such as physical exercises for sleep disturbances. Both aerobic and mind-body exercises demonstrated well-established beneficial effects on sleep quality and other health-related outcomes in patients with lung cancer. While aerobic exercise is the most prevalent type of exercise modality being studied, mind-body exercises such as tai chi is another modality gaining popularity. However, the comparative effect of aerobic exercises and tai chi on sleep quality is lacking in this population. The aim of the study was to examine and compare the effectiveness of aerobic exercise (AE) and tai chi (TC) intervention with self-management control group in improving subjective sleep quality, other associated psychosocial outcomes and objective biomarkers, and one-year survival rate in patients with advanced lung cancer. This study adopted an assessor-blinded, multi-centered, three-arm randomized controlled trial design. A total of 226 patients with advanced lung cancer were recruited and randomized into AE group (n=75), TC group (n=76), and self-management control group (n=75). For 16 weeks, the AE group received eight 60 minutes supervised exercise sessions and home-based exercises; TC group received 60 minutes classes twice a week; whereas control group received information on the physical activity guideline. Outcome measures included subjective and objective quality of sleep, fatigue, psychological distress, health-related quality of life, cardiorespiratory fitness, physical functioning, step count, circadian rhythm, and one-year survival rate. Assessments were done at baseline, post-intervention (T1), and eight months post-intervention (T2). Overall, the drop-out rates were 17.26% and 36% at T1 and T2, respectively. Analysis based on the intention-to-treat principle indicated significant group x time interaction effects in AE and TC for subjective sleep quality at T1 (AE: d, -3.706, P&lt;0.001; TC: d, -3.751, P&lt;0.001), and T2 (AE: d, -3.034, P&lt;0.001; TC: d, -4.070, P&lt;0.001), as well as anxiety, depression, cardiorespiratory fitness, physical functioning tests, step count, diurnal cortisol slope, and one-year survival rate. This is the first study that provides evidence of the comparative effect of AE and TC on subjective sleep quality and numerous health-related outcomes in patients with advanced lung cancer. The results indicate that AE and TC were superior to self-management control for alleviating sleep disturbances and other health-related outcomes, with statistically significant results reached, while the effects of AE and TC were comparable. Notably, AE enhanced agility, while TC improved balance ability and fatigue. As both exercise interventions are effective at improving physical and psychological outcomes, patients can be advised to engage in either one based on their preferences. Given the safe nature of exercise, it could be considered a complementary therapeutic option for holistic management of advanced cancer.