Effectiveness of Exercise Training in Improving Sleep in Patients With Systemic Lupus Erythematosus: A Controlled Randomized Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.
详细描述
This study will test the effectiveness of aerobic exercise on improving sleep in patients with systemic lupus erythematosus. The subjects will do treadmill 2 times per week, from 15-20 min. with low to moderate(55-65% maxCF) intensity exercise, so 30 min. until 4ª week. From the 5ª to 8ª week they will be able to make greater efforts to 35-40 min. totalizing 16 weeks. The control group will not do exercise and will receive education class about disease, health, sleep, 1 time per month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Systemic Lupus Erythematosus (SLE) according American College of Rheumatology (ACR) Criteria revised in 1997;
- •Pittsburgh sleep quality index (PSQI) ≥ 5;
- •Free and Clarified Consent Term signature.
排除标准
- •Patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis), excerpt mild osteoarthritis;
- •Systemic Lupus Erythematosus Disease Assessment Index (SLEDAI) > 8;
- •Untreated diseases: Hypertension, diabetes mellitus (DM), dyslipidemia, thyroid dysfunction, cardiorespiratory diseases, malignancies;
- •Patients who do not accept the study rules as time and/or follow-up exercise program time proposed;
- •Suspected or pregnancy confirmation;
- •* Patients who are taking sleeping medication;
- •Patients who won´t sign the Free and Clarified Consent Term informed;
- •Patients engaged in physical activity (defined as previously sedentary individuals, or that which do not perform any type of regular physical activity at least six months);
结局指标
主要结局
Sleep Efficiency
时间窗: 16 weeks
Sleep efficiency will be evaluate with actigraph. The subject will use it for 15 days before the period of exercise, 15 days at the start of the period of exercise, and then 15 last days in the period of exercise. Complementing the information collected by the device, the patient will complete a sleep diary, with schedules of activities such as: time they go to bed, time they fall asleep, time they get up, times they remove the device (which is not waterproof), times they replace the device, and times they wake up from naps.
Sleep quality
时间窗: 16 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that includes 21 items that assess the quality of sleep during a one-month period. The subject will be asked it, before, during and after the period of exercise. The questionnaire is divided into seven components: subjective sleep quality, sleep latency, sleep duration, sleep effectiveness, sleep disorder, use of sleep medication, and daytime dysfunction. On the PSQI a score ≥ 5 indicates poor quality of sleep, and ≤ 4 indicates good quality of sleep.
次要结局
- Quality of life assessment(16 weeks)
- Disease activity assessment(16 weeks)
- Fatigue assessment(16 weeks)
- Restless Legs Syndrome gravity assessment(16 weeks)
- Pain assessment(16 weeks)
研究者
Lilian K C Reis, Principal Investigator
Principal Investigator
Federal University of São Paulo