Fibromyalgia Clinical Trial
Official title:
Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial
Verified date | April 2018 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | December 29, 2017 |
Est. primary completion date | November 10, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Physiotherapy, University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proprioception | 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 | |
Secondary | Balance | 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 | |
Secondary | Handgrip strength | 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 | |
Secondary | Joint range of motion | 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 | |
Secondary | Pain | Evaluated by the McGill Pain Questionnaire (MPQ). The MPQ includes 4 main measures: 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. 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. 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). Pain pattern. Participants respond to the question, "How does your pain change with time?" by selecting from 9 words. |
8 weeks | |
Secondary | Leisure Time Physical Activity | 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 | |
Secondary | Impact on quality of life | 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 GarcĂa-Leiva in 2013, and it showed an excellent internal consistency (Cronbach's alpha = 0.95). | 8 weeks | |
Secondary | Anxiety and Depression | 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 | |
Secondary | Fatigue | 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 | |
Secondary | Sleep disorders | 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 |
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