Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Combined Protocol Based on Physical Exercise and Muscle Stretching
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pittsburgh sleep quality index
研究概览
简要总结
This study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.
详细描述
Although classically this pathology was characterized by having an unknown etiology, current research suggests that the disease shows several abnormalities in the central pain processing.
Central sensitization is defined as changes in neuroplasticity of central nervous system as a result of persistent and intense sensory information nociceptive generated by peripheral and transmitted to the neurons in the dorsal horn of the cord through the nerves of the peripheral nervous system tissues, through a constant activity of C fibers and A-beta fibers.
In recent years the theory that pain is responsible for other symptoms, is changing, and it is theorized that the quality of sleep directly influences in the symptoms.
The treatment of fibromyalgia is based on trying to reduce pain and associated symptoms described above in order to improve the quality of life of these patients. Almost all revisions studying the effects of physical activity in fibromyalgia agree that it is effective in reducing the overall impact on the disease and its symptoms.
Muscle strength training aim to improve the strength, endurance and muscle power. There are few conclusive studies on the benefits of stretching and flexibility exercises on the impact of fibromyalgia.
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 (Participant, Investigator)
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
- •Be 18 years or more.
- •To be diagnosed with fibromyalgia according to the criteria established by the "American College of Rheumatology", either on the basis of its publication of 1990 or the current revision of
- •Accept to volunteer and give oral consent. Before starting the intervention must be provided written informed consent.
排除标准
- •Do not present any pathology in which physical exercise is contraindicated.
- •Do not suffer another serious somatic illness or severe psychological disorder. Not suffer severe dementia (MMSE <10).
- •Do not be participating at the time of the study in any other intervention of physical or psychological.
结局指标
主要结局
Pittsburgh sleep quality index
时间窗: At the beginning, every two weeks up to 12 weeks
The Pittsburgh Sleep Quality Index, where a lower score (0-21), better sleep quality. Follows a continuous metric scale.
次要结局
- Epworth sleepiness scale(At the beginning, every two weeks up to 12 weeks)
- Sleep scale (medical outcomes study)(At the beginning, every two weeks up to 12 weeks)
- Fibromyalgia impact questionnaire(At the beginning, every two weeks up to 12 weeks)
- Visual analog scale(At the beginning, every two weeks up to 12 weeks)
研究者
Fco. Javier Montanez Aguilera
PhD
Cardenal Herrera University