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临床试验/NCT04119778
NCT04119778已完成不适用

Improving Sleep in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
226
试验地点
1
主要终点
Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index

研究概览

简要总结

Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in improved sleep are needed.

Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better sleep of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving sleep outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on sleep of lung cancer patients.

This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 16-week aerobic exercise group, 2) a 16-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged.

Through this project, the investigators aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention promote subjective sleep quality in lung cancer patients compared to control, as the primary outcome of this study. The investigators shall also examine if tai-chi practice can provide similar improvement in sleep quality compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with sleep outcomes will be further explored.

Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve sleep of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
  • Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
  • Patients aged 18 years old, or above
  • Patients who can communicate in Cantonese, Mandarin
  • Patients with no other cancer diagnosis within the previous 1 year
  • Patients report not doing regular exercises (defined <150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times
  • Patients with ECOG 0-1
  • Patients being conscious and alert.
  • Patients who can read and write in Chinese

排除标准

  • Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia)。

结局指标

主要结局

Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index

时间窗: 1 year

To assess the change of quality of sleep, the Chinese version of the Pittsburgh Sleep Quality Index, from baseline at 16-week and 1 year

次要结局

  • One-year survival rate(1 year)
  • Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation(Baseline, 1 year)
  • Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire(Baseline, 16-week, 1 year)
  • Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core corresponding lung cancer-specific module(Baseline, 16-week, 1 year)
  • Quality of Sleep (Objective)- Actigraph(Baseline, 16-week, 1 year)
  • Levels of physical activity(Baseline, 16-week, 1 year)
  • Circadian rhythms- cortisol rhythms(Baseline, and 1 year)
  • Cardio-respiratory fitness- 6-minute walking test(Baseline, 16-week, 1 year)
  • Physical functioning- single leg standing test(Baseline, 16-week, 1 year)
  • Psychological Distress- Hospital Anxiety and Depression Score(Baseline, 16-week, 1 year)
  • Circadian rhythms- melatonin rhythms(Baseline, and 1 year)
  • Physical functioning- timed up and go test(Baseline, 16-week, 1 year)
  • Physical functioning- Get Active Questionnaire(Baseline, 16-week, 1 year)
  • Physical functioning-sit to stand test(Baseline, 16-week, 1 year)
  • Fatigue- Brief Fatigue Inventory(Baseline, 16-week, 1 year)
  • Fried frailty Criteria(Baseline, 16-week, 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Chia-Chin Lin

Professor and Head

The University of Hong Kong

研究点 (1)

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