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Postural Exercises in Women With Fibromyalgia

2018年4月3日 更新者:Marta Inglés de la Torre、University of Valencia

Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial

In the current study, the investigators aimed to study:

  • The proprioception status of patients with FMS.
  • The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.

研究概览

详细说明

Fibromyalgia syndrome (FMS) is a multisystemic disease, characterized by generalized chronic musculoskeletal pain. In addition, it is usually accompanied by fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function.

It constitutes the second most common rheumatic 36 disorder after osteoarthritis, with a prevalence of 2.9% in Europe and a fivefold times greater incidence among women than men.

Patients with FMS have pain at specific pressure points known as "tender points", with increased sensitivity to painful stimuli (hyperalgesia) and a decreased pain threshold (allodynia), in the absence of abnormalities in the biological or imaging tests. These tender points constitute the basis of the most sensitive and specific criteria for the diagnosis of the disease, this is, the criteria of the American College of Rheumatology. Accordingly, women presenting at least 11 of 18 tender points are diagnosed with FMS.

The etiology of FMS remains unclear. However, the generalized hyperalgesia, widespread pain and spontaneous pain in FMS have been related to central changes, and many studies support a major role for central sensitization in the generation of the symptoms of FMS.

Since it is a chronic disease, the care of this type of patients represents a significant economic burden. They have great health care resource requirements in both direct medical care and indirect costs of staff absenteeism. For these reasons, it is considered a major problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease.

In general, the goal of the treatment should be to improve function. In this regard, some studies have demonstrated the efficacy of low-cost therapeutic measures, such as physical exercise programs, to improve FMS symptoms. Physical exercise has a direct effect on pain, joint and muscle stiffness, generalized sensitivity fatigue, cognitive function. Since there is no standard program, it is difficult to determine which exercise modality is most effective on FMS. Most studies focus on low-impact aerobic exercise performed between 60-70% of maximal heart rate two to three times a week.

On the other hand, it has been proposed that motor control problems, due mainly to an alteration of the central and peripheral system, are associated with muscle strength loss, motor or sensory deficits and suboptimal muscle coordination. The lack of balance may also be due to a disturbance in the perception or interpretation of auditory- vestibular signals. Therefore, postural stability training is recommended to stimulate the neuromuscular system and develop proprioceptive capacity aimed at improving motor control and postural balance among these patients. In this regard, it is important to note that FMS is associated with postural control and balance impairments, the latter being one of the 10 most debilitating symptoms, with a prevalence of 45%.

In the current study, the investigators aimed to study:

  • The proprioception status of patients with FMS.
  • The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.

研究类型

介入性

注册 (实际的)

54

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Valencia、西班牙、46010
        • Faculty of Physiotherapy, University of Valencia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Aged between 30 and 65 years.
  • Meeting ACR 2010 criteria for FMS.

Exclusion Criteria:

  • Medical contraindication for physical activity.
  • Deafness or limited hearing.
  • Vestibular disorders that compromise balance.
  • Low vision or blindness.
  • Psychotic disorder or cognitive impairment.
  • Decompensation or changes in medication.
  • Surgical interventions in the last six months.
  • Rheumatic disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental group 1
Low impact aerobic exercise group. 1hour, twice a week
The intervention will consist of working the muscles that are most affected by FMS through group exercises, which will be dynamic, fluid and aimed at improving functionality. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); games, group dynamics and aerobics (30 minutes); and cool down with stretching for 15 minutes.
实验性的:Experimental group 2
Postural exercises group. 1hour, twice a week
The intervention will consist of performing postural exercises in prone, supine, sitting and standing position, as well as in quadrupedia. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); postural exercises (30 minutes); and cool down with stretching for 15 minutes.
无干预:Control propriocepcion
No exercise, just proprioceptive control.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proprioception
大体时间:8 weeks
Proprioception will be evaluated at baseline and at the end of the study possible differences between women with fibromyalgia and healthy women using an isokinetic device (BIODEX MULTI-JOINT SYSTEM - PRO). The following movements were analized: knee (flexion, extension), hip (flexion, extension, abduction, adduction), ankle (flexion, extension), shoulder (flexion, extension). Joint position sense for knee extension and shoulder flexion will be also performed.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
Balance
大体时间:8 weeks
Evaluated by the Berg Balance Scale. This consists of 14 items, in which static and dynamic balance is assessed. Subjects are asked to perform balance related tasks of varying difficulties (from standing up from a sitting position to monopedal standing). According to the ability to carry out the assessed activity, each task is scored on a 5-point scale (0= lowest level of function, 4= highest level of function). The final measure is the sum of all the scores (maximum=56 points) and higher scores are indicative of greater functional balance. This test has shown excellent intra-rater reliability (ICC = 0.97) and test-retest reliability (ICC = 0.91).
8 weeks
Handgrip strength
大体时间:8 weeks
Grip strength will be measured by a Jamar Analogue Hand Dynamometer with participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position. Subjects were verbally encouraged to produce their maximal grip strength (MGS). Three trials were recorded, consisting of a 3-second maximal contraction, with a 30-second rest period between each trial. The maximal value of the three reproducible trials for each hand was retained for analyses.
8 weeks
Joint range of motion
大体时间:8 weeks
Ranges of movement of different joints were evaluated by a goniometer and an inclinometer: Shoulder (flexion, extension, abduction, adduction, internal and external rotation), hip (flexion, extension, abduction, adduction, internal and external rotation), knee (flexion and extension), ankle (flexion, extension, abduction, adduction, internal rotation and external rotation), cervical spine (flexion, extension, rotations and inclinations). For the measurements, subjects were in underwear or wore comfortable clothes.
8 weeks
Pain
大体时间:8 weeks

Evaluated by the McGill Pain Questionnaire (MPQ). The MPQ includes 4 main measures:

  1. Pain location. On a drawing of the human body with both anterior and posterior sides, participants indicate the areas of their bodies that have pain. The number of pain sites is summed as in indicator of the sensory pain dimension.
  2. Pain intensity. From a list of 6 words, the patient selects the one best word describing the intensity of pain: 0 = none, 1= mild, 2 = discomforting, 3 = distressing, 4 = horrible and 5 = excruciating.
  3. Pain quality. Participants respond to the question, "What does your pain feel like?" by selecting from 78 descriptors in 20 subclasses. The quantitative data is summed to form the Pain Rating Index (PRI) (score 0 no pain- 78 worst possible pain).
  4. Pain pattern. Participants respond to the question, "How does your pain change with time?" by selecting from 9 words.
8 weeks
Leisure Time Physical Activity
大体时间:8 weeks
Evaluated by the Leisure Time Physical Activity Instrument (LTPAI). It is an instrument assessing the amount of physical activity performed during a typical week. The physical activities are divided into three categories: light, moderate, and heavy activities. The LTPAI total score is the sum of hours in all three categories.
8 weeks
Impact on quality of life
大体时间:8 weeks
Evaluated by the Fibromyalgia Impact Questionnaire (FIQ). This is a multidimensional self-administered questionnaire with 10 items that evaluates the status of the patient the week before the test is completed, and it assesses the aspects that tend to be more affected in people with FMS. The first item contains 10 sub-items, ranging from four points (from 0= always to 3 = never) and assesses the patient's functional capacity in activities of daily living. The second and third items refer to days of the week and the rest are visual analog scales from 0 to 10. The score ranges from 0 to 100, where 0 represents the maximal functional capacity quality of life and 100 the minimum. This scale was validated in its Spanish version by Salgueiro and García-Leiva in 2013, and it showed an excellent internal consistency (Cronbach's alpha = 0.95).
8 weeks
Anxiety and Depression
大体时间:8 weeks
Assessed by the Hospital Anxiety and Depression Scale (HADS). This is a valid and reliable self-rating scale with 14 items that measures anxiety and depression (7 of the items relate to anxiety and 7 relate to depression). Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression, with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.
8 weeks
Fatigue
大体时间:8 weeks
Fatigue Severity Scale (FSS). The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items.
8 weeks
Sleep disorders
大体时间:8 weeks
Evaluated by the Pittsburgh Sleep Quality Index (PSQI). It is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Marta Inglés, PhD、Faculty of Physiotherapy. University of Valencia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月4日

初级完成 (实际的)

2017年11月10日

研究完成 (实际的)

2017年12月29日

研究注册日期

首次提交

2017年5月23日

首先提交符合 QC 标准的

2017年5月23日

首次发布 (实际的)

2017年5月25日

研究记录更新

最后更新发布 (实际的)

2018年4月4日

上次提交的符合 QC 标准的更新

2018年4月3日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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