The Effects of Aerobic Exercise on Sleep Quality, Fatigue, Quality of Life, Depression, Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Change from baseline disease activity score (DAS28) at 4th week
研究概览
简要总结
The aim of our study is to investigate the effects of aerobic exercise on sleep quality, fatigue, quality of life, depression and serum BDNF and irisin levels, which are important biomarkers of sleep in patients with rheumatoid arthritis.
详细描述
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized primarily by inflammation of synovial joints and tendon sheaths of synovial nature.
Sleep disturbance in RA patients has a negative impact on their quality of life in addition to their mental and physical health. Exercise has been identified as an important non-pharmacological factor in improving sleep quality and mood in patients with rheumatoid arthritis.
Irisin is a myokine and adipokine that has anti-inflammatory effects and can help regulate energy expenditure. It is secreted from skeletal muscles after exercise, as well as from other tissues such as the liver, nerves, heart, kidneys and skin. It has been observed that serum irisin levels are decreased in RA patients with poor sleep quality compared to RA patients with good sleep quality.
BDNF, one of the biochemical parameters evaluating sleep, is a signal protein encoded by the BDNF gene located on chromosome 11. It belongs to the neurotrophin family, which regulates the survival, development and function of neurons. Neuronal activity is a powerful stimulant that elicits BDNF production. Thus, activation of brain areas associated with motor control during exercise contributes to increased BDNF production in the brain and additionally in plasma. During acute exercise, irisin stimulates BDNF expression in the hippocampus of the brain. In addition to the circadian variation of plasma BDNF, the blood concentration of BDNF has been shown to increase acutely in response to aerobic exercise that does not include resistance exercise. Moreover, it has been reported that people with higher basal serum BDNF concentrations have lower REM sleep and therefore less sleep disturbances.
This investigation was designed as prospective randomized controlled study. Participants were randomized into 3 groups; RA patients receiving aerobic and home exercise, RA patients receiving only home exercise and healthy control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were included in the study
- •Male and female gender between the ages of 20 and 60 who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR diagnostic criteria,
- •Patients with Disease Activity Score (DAS28) ≤3.2 (low disease activity or remission) (no change in anti-rheumatic drugs or steroid dose in the last 3 months),
- •Patients who were being followed at Afyonkarahisar Health Sciences University Department of Physical Medicine and Rehabilitation,
排除标准
- •Active malignancy and/or a history of malignancy within the past 5 years,
- •Uncontrolled cardiopulmonary disease (such as severe hypertension, chronic obstructive pulmonary disease, stage 3 or 4 heart failure, significant left ventricular outflow obstruction, dissecting aneurysm, embolism or thrombophlebitis history),
- •Patients who cannot tolerate cardiorespiratory exercise training due to unstable angina pectoris, dangerous cardiac arrhythmias and myocardial infarction in the last 3 months,
- •Pregnancy or planning a pregnancy in the near future,
- •History of major surgery (including joint surgery) within the last six months,
- •Regular physical activity at least 3 days a week in the last 3 months,
- •Orthopedic, neurological or mental disease that may affect exercise,
结局指标
主要结局
Change from baseline disease activity score (DAS28) at 4th week
时间窗: Up to 4th week
DAS 28 is a scale consisting of 4 parameters; tender and swollen joint counts from 28 joints (shoulders, elbows, wrists, MCFs,PIPs and knee joints), blood sedimentation (mm/hour) or CRP (mg/liter) value and patient global assessment (between 0 and 100; Best imaginable health condition-100, The worst possible health condition -0) A mathematical formula is used to calculate the overall score. DAS28 can range from 0 to 9.4.Generally, a DAS28 score of; * More than 5.1 indicates high disease activity * Between 3.2 and 5.1 indicates moderate disease activity * Between 2.6 and less than 3.2 indicates low disease activity * Lower than 2.6 indicates disease remission It is only applied to Rheumatoid Arthritis patients.
次要结局
- Change from baseline quality of life (short form 36 (SF-36)) at 4th week(Up to 4th week)
- Change from baseline Fatigue Severity Scale (FSS) at 4th week(Up to 4th week)
- Change from baseline Six Minute Walk Test (6MWT) at 4th week(Up to 4th week)
- Change from baseline Beck's Depression Inventory (BDI) at 4th week(Up to 4th week)
- Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 4th week(Up to 4th week)
- Change from baseline Borg Rating Of Perceived Exertion Scale (Borg RPE Scale) at 4th week(Up to 4th week)
研究者
Hatice Kudret Miroğlu
Research Assistant Doctor
Afyonkarahisar Health Sciences University