Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
Fibromyalgia syndrome is the most common cause of chronic generalized musculoskeletal pain and is characterized by pain associated with generalizad sensitivity, fatigue, sleep disturbances and psychological problems. Due to the chronic nature of the pathology and the great dependence on analgesic drugs that it often entails, in these patients it is considered necessary to provide an individualized approach and provide strategies that allow symptoms to be controlled conservatively and non-pharmacologically.
The objective of this trial is to analyse the immediate effects on pain, mechanical pain sensitivity, impact of fibromyalgia, pain catastrophizing, psychological distress and physical function when a telerehabilitation program based on aerobic exercise is applied in women with fibromyalgia.
For this purpose the investigators conduct a randomized controlled trial single-blind (examiner). The investigators included female patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Thirty-four women with fibromyalgia are included and randomized into 2 groups: telerehabilitation program group based on aerobic exercise and control group. Exercise group receive 2 treatment sessions a week over 15 weeks.
All the variables are measured at the beginning of intervention and after the intervention.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed medically with Fibromyalgia
- •Diagnosed according to the American College of Rheumatology criteria
- •Age between 30 and 75 years old
- •Telerehabilitation equipment including a laptop computer and access to internet
排除标准
- •Any kind of contraindications for physical activity
- •Other physical or psychological therapies in the last 3 months.
- •Medication modifications in the last 3 months
结局指标
主要结局
Pain Intensity
时间窗: Post-intervention, an average 15 weeks
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention. The scale score ranges from 0 to 100 and higher scores indicate greater pain intensity.
次要结局
- Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)(Post-intervention, an average 15 weeks)
- Pressure Pain Threshold(Post-intervention, an average 15 weeks)
- Psychological distress(Post-intervention, an average 15 weeks)
- Mechanical pain sensitivity(Baseline)
- Pain Catastrophizing(Post-intervention, an average 15 weeks)
- Upper limb function(Post-intervention, an average 15 weeks)
- Lower limb function(Post-intervention, an average 15 weeks)
研究者
Ignacio Hernando Garijo
Physiotherapist
University of Valladolid