Inspiratory Muscle Training in Respiratory Capacity, Life Quality, Lumbar Pain, Phase Angle and Body Composition in Patients With Fibromyalgia.
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
- Pain :VAS
研究概览
简要总结
Context/background: people affected by fibromyalgia see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.
Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, lumbar pain, quality of life, phase angle and body composition in patients with Fibromyalgia.
The participants of experimental group will conduct 5 sets of 10 inspirations per day, 5 days per week, through 8 weeks.
详细描述
Methods: 40 volunteer patients, female, with fibromyalgia will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 20) and a control group (n = 20). The Maximum Inspiratory Pressure (PIM), the quality of life, lumbar pain, phase angle and body composition will be measured.
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 inspirations, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP
After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with fibromyalgia
排除标准
- 未提供
研究组 & 干预措施
No training program
Without inspiratory muscle training. Treatment asusual.
Inspiratory muscle training
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
干预措施: Inspiratory Muscle Training with Powerbreath IMT device. (Other)
结局指标
主要结局
Pain :VAS
时间窗: change from baseline after 8 week
Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
phase angle
时间窗: 8 week
The phase angle, which is measured via bioelectrical impedance analysis (BIA), InBody 770 ,is a clinically important bioimpedance parameter used for nutritional assessment and evaluating the risk of various diseases. The phase angle was calculated automatically by the BIA device from these two components according to the following formula: phase angle (°) = (reactance/resistance) × (180°/π).
Fibromyalgia Impact Questionnaire (S-FIQ)
时间窗: 8 week
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.
MIP
时间窗: Change from baseline inspiratory muscle strength at 8 weeks]
Maximum Inspiratory Pressure. Inspiratory muscle strength will be measured in % by a POWER-breathe device
Pain: Pressure algometry
时间窗: 8 week
Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.
Diaphragm tickness
时间窗: Change from baseline diaphragm muscle thickness at 8 weeks
Diaphragm muscle thickness will be measured in mm by an ultrasound device
次要结局
未报告次要终点