Improving Sleep in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions
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
- 否
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)。
研究组 & 干预措施
Aerobic Exercise
The exercise intervention will last 16 weeks, comprised of home-based exercise with weekly telephone counselling to encourage participants to continue to exercise, supplemented with 8 supervised exercise sessions (2 sessions per month). Each session will last for an hour. The supervised exercise sessions will be provided by professional exercise specialists twice in the first week in each month throughout the intervention period, an hour each time. Exercise trainers will lead the classes. Each class will include both aerobic exercise and resistance exercise. They are encouraged to do aerobic exercise for at least 150 min weekly at a moderate intensity level, as well as perform resistance exercises alternate day. Participants are also provided an exercise diary, containing details of their weekly prescribed exercises and the scales they have to refer to.
干预措施: Aerobic Exercise, Tai chi (Behavioral)
Tai chi
Our tai-chi classes will be based on a 16-form tai-chi exercise set. The classes will run twice a week for 16 weeks with each session lasting approximately 60 minutes. Classes will be taught by an experienced tai-chi master, who will explain the theory behind tai-chi and the principles of the techniques. The supervised session includes a warm up, self-massage and a guided run through of the movements, breathing techniques, and relaxation in tai-chi. The tai-chi master will guide participants to practice the tai-chi they learn in the classes at home each day. Upon completion of the 16 weeks course, participants will be encouraged to continue their tai-chi practice, given guidance on local services and programmes they may join if they wish to.
干预措施: Aerobic Exercise, Tai chi (Behavioral)
Self Management Group
Participants randomised to the control group shall receive written information on health levels of physical activity, which they can participate in at home (self-management) and continue to receive their usual care, participants will be followed up with an assessment at 16 weeks and one year. At the end of the evaluation stage of the study, survivors in the control group will be invited to take part in an intervention of their choice.
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
- Physical functioning- timed up and go test(Baseline, 16-week, 1 year)
- Physical functioning-sit to stand test(Baseline, 16-week, 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)
- One-year survival rate(1 year)
- Circadian rhythms- melatonin rhythms(Baseline, and 1 year)
- Physical functioning- Get Active Questionnaire(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
Professor Chia-Chin Lin
Professor and Head
The University of Hong Kong