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Postural Exercises in Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low impact aerobic exercise
Postural exercises
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia,postural exercises

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Physiotherapy, University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group 1

Experimental group 2

Control propriocepcion

Arm Description

Low impact aerobic exercise group. 1hour, twice a week

Postural exercises group. 1hour, twice a week

No exercise, just proprioceptive control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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 García-Leiva in 2013, and it showed an excellent internal consistency (Cronbach's alpha = 0.95).
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.
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.
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.

Full Information

First Posted
May 23, 2017
Last Updated
April 3, 2018
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03166995
Brief Title
Postural Exercises in Women With Fibromyalgia
Official Title
Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia,postural exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Low impact aerobic exercise group. 1hour, twice a week
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Postural exercises group. 1hour, twice a week
Arm Title
Control propriocepcion
Arm Type
No Intervention
Arm Description
No exercise, just proprioceptive control.
Intervention Type
Other
Intervention Name(s)
Low impact aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Postural exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proprioception
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Balance
Description
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).
Time Frame
8 weeks
Title
Handgrip strength
Description
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.
Time Frame
8 weeks
Title
Joint range of motion
Description
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.
Time Frame
8 weeks
Title
Pain
Description
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.
Time Frame
8 weeks
Title
Leisure Time Physical Activity
Description
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.
Time Frame
8 weeks
Title
Impact on quality of life
Description
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).
Time Frame
8 weeks
Title
Anxiety and Depression
Description
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.
Time Frame
8 weeks
Title
Fatigue
Description
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.
Time Frame
8 weeks
Title
Sleep disorders
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Inglés, PhD
Organizational Affiliation
Faculty of Physiotherapy. University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy, University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Postural Exercises in Women With Fibromyalgia

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