Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- sleep
研究概览
简要总结
Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep.
This study is a randomized controlled trial of 44 patients with rheumatoid arthritis.
The aim is to investigate the effect of a moderate-to-high intensity aerobic interval training intervention on sleep quality and sleep disturbances in patients with rheumatoid arthritis.
The primary hypothesis is that moderate-to high intensity aerobic exercise will improve objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.
详细描述
Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity, including cardiovascular diseases, diabetes, hypertension, and all-cause mortality. In addition, poor sleep quality is associated with fatigue, pain and physical disability. Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep in healthy people and patients with insomnia.
The present study is a blinded randomized controlled trial of 44 patients with a diagnosis of rheumatoid arthritis.
The aim is to examine the effect of an aerobic exercise intervention, consisting of 18 exercise sessions, on sleep quality and sleep disturbances in patients with rheumatoid arthritis who experience poor sleep quality.
The primary hypothesis is that moderate to high intensity aerobic exercise will improve objective measured (by polysomnography) sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.
The study will provide evidence on the effect of moderate-to-high-intensity aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis. Specifically, the results are expected to provide important evidence about the potential of interval training to improve quality of sleep and sleep disturbances. As such, the study meets a currently unmet need for non-pharmacological treatment initiatives of poor sleep in patients with a systemic inflammatory disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years
- •a clinical diagnosis of rheumatoid arthritis
- •Experience poor sleep quality (PSQI >5)
- •Low disease activity (DAS28<3.2)
- •Understand Danish
排除标准
- •Documented sleep apnea (AHI >15/hour)
- •ECG that does not allow exercise
- •Night work during the period in which the intervention takes place
- •Pregnant or are breast-feeding
- •Treatment with steroid, hypnotics, antidepressants, antipsychotics
- •Cardiac symptoms - NYHA >2
- •Regular physically active (aerobic exercise >3 x per week)
结局指标
主要结局
sleep
时间窗: Change from baseline in objectively measured sleep to 8 weeks
Measured by polysomnography. Polysomnography is a objective measurement of sleep duration, sleep stages and sleep quality.
次要结局
- Health and lifestyle questionnaire(change from baseline in health and lifestyle to 8 weeks)
- Sleep pattern(change from baseline to 8 weeks)
- self reported sleepiness(change from baseline in sleepiness to 8 weeks)
- Disease activity(change from baseline in disease activity to 8 weeks)
- self reported depressive symptoms(change from baseline in depressive symptoms to 8 weeks)
- Plasma(change from baseline in plasma to 8 weeks)
- self reported Health-related quality of life(change from baseline in health related quality of life to 8 weeks)
- Cardiopulmonary fitness(change in baseline in VO2-max to 8 weeks)
- self reported sleep quality and sleep disturbances(change from baseline in selfreported sleep to 8 weeks)
- self reported fatigue(change from baseline in fatigue to 8 weeks)
- physiological outcomes(change from baseline in blood pressure, weight and height to 8 weeks)
- Physical function(change from baseline in HAQ score to 8 weeks)
研究者
Katrine Loeppenthin
PhD student
Glostrup University Hospital, Copenhagen