Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

Detailed Description
-----------------
Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.

Official Title
-----------------
Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: Strength exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria at least 18 years old Exclusion Criteria: severe comorbidity or any other type of condition that negatively influences participation in the training program cognitive disorders heart problems surgeries or fractures in the last 6 months regular practice of physical exercises in the least 3 months before program.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>8 weeks of strength training. | Other: Strength exercise<br>* The protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days.<br>|
| No Intervention: Control<br>Maintain their usual medical treatment and daily routines | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Force plate | Change from Baseline balance at week 9 | 
| Balance | Force plate | Change from Baseline balance at week 12 | 
| Balance | Force plate | Change from week 9 balance at week 12 | 
| Neuromuscular performance | Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs. | Change from Baseline neuromuscular performance at week 9 | 
| Neuromuscular performance | Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs. | Change from Baseline neuromuscular performance at week 12 | 
| Neuromuscular performance | Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs. | Change from week 9 neuromuscular performance at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia impact questionnaire | Questionnaire to ccess information on the functional capacity and health status of individuals with fibromyalgia. Composed of 20 questions. , the values vary from 0 to 100, in which the higher the value, the greater the impact of fibromyalgia. | Baseline, week 9, week 12 | 
| Pain intensity | Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose. | baseline and everyday until the week 12 | 
| Anxiety | Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose. | baseline and everyday until the week 12 | 
| Quality of sleep | Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose. | baseline and everyday until the week 12 | 
| Fatigue | Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose. | baseline and everyday until the week 12 | 
| Mood state | Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose. | baseline and everyday until the week 12 |