Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in the Treatment of Patients With Fibromyalgia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Fibromyalgia impact
研究概览
简要总结
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
详细描述
Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercise in the treatment of patients with fibromyalgia. For this, the following outcomes of 98 patients will be evaluated by a blinded evaluator at baseline, 8 weeks, 6 and 12 months after randomization: fibromyalgia impact assessed by the Fibromyalgia Impact Questionnaire, pain intensity assessed by the Pain Numerical Rating Scale, kinesiophobia assessed by the Tampa Scale for Kinesiophobia, specific disability assessed by the Patient-Specific Functional Scale, functional capacity assessed by the 6-minute Walk Test, quality of sleep assessed by the Pittsburgh Sleep Quality Index, and health-related quality of life assessed by the EQ-5D-3L and SF-6D questionnaires. Participants will be randomly divided into Aerobic Group, who will perform aerobic exercises on treadmills and/or stationary bikes, and Pilates Group, which will perform exercises of the modified Pilates method. Both groups will be treated for eight weeks, twice a week. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that meet the criteria for classification of fibromyalgia according to the criteria of the American College of Rheumatology 2010; and
- •Pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale
排除标准
- •Contraindications to physical exercise
- •Pregnancy
- •Uncontrolled systemic diseases (diabetes mellitus, systemic arterial hypertension and thyroid dysfunctions);
- •Neurological, cardiorespiratory and musculoskeletal conditions that interfere with treatment such as: paralysis, significant changes in sensitivity, changes in level of consciousness and understanding, advanced joint diseases (severe arthrosis, hip or knee arthroplasty, severe rheumatoid arthritis), cervicalgia with irradiation to the upper limbs, among others;
- •Injury or severe pain in the lower limbs that limit the performance of aerobic exercises: meniscus injury, plantar fasciitis, among others;
- •Partial or total muscular ruptures;
- •Amputations;
- •Recent postoperative; and
- •Inability to understand the writing and speaking of the Portuguese language.
结局指标
主要结局
Fibromyalgia impact
时间窗: Eight weeks after randomization
This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items. Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never). In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days. Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
次要结局
- Pain intensity(Eigth weeks, before and after each intervention session)
- Specific disability(Eight weeks, six and twelve months after randomization)
- Kinesiophobia(Eight weeks, six and twelve months after randomization)
- Quality of sleep(Eight weeks, six and twelve months after randomization)
- Health-related quality of life using the SF-6D(Eight weeks, six and twelve months after randomization)
- Health-related quality of life using the EQ-5D-3L(Eight weeks, six and twelve months after randomization)
- Fibromyalgia impact(Six and twelve months after randomization)
- Functional capacity(Eight weeks after randomization)
研究者
Cristina Maria Nunes Cabral
Professor
Universidade Cidade de Sao Paulo