Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

Study Overview
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Brief Summary
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Context/background: people affected by fibromyalgia see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis. Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, lumbar pain, quality of life, phase angle and body composition in patients with Fibromyalgia. The participants of experimental group will conduct 5 sets of 10 inspirations per day, 5 days per week, through 8 weeks.

Detailed Description
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Methods: 40 volunteer patients, female, with fibromyalgia will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 20) and a control group (n = 20). The Maximum Inspiratory Pressure (PIM), the quality of life, lumbar pain, phase angle and body composition will be measured. Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 inspirations, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.

Official Title
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Inspiratory Muscle Training in Respiratory Capacity, Life Quality, Lumbar Pain, Phase Angle and Body Composition in Patients With Fibromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Inspiratory Muscle Training with Powerbreath IMT device.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with fibromyalgia Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training<br>Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual | Other: Inspiratory Muscle Training with Powerbreath IMT device.<br>* Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 repetitions, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP<br>|
| No Intervention: No training program<br>Without inspiratory muscle training. Treatment asusual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MIP | Maximum Inspiratory Pressure. Inspiratory muscle strength will be measured in % by a POWER-breathe device | Change from baseline inspiratory muscle strength at 8 weeks] | 
| Pain: Pressure algometry | Pain will be measured with pressure algometry measured in Kg from 0 to 5kg. | 8 week | 
| Pain :VAS | Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain. | change from baseline after 8 week | 
| phase angle | The phase angle, which is measured via bioelectrical impedance analysis (BIA), InBody 770 ,is a clinically important bioimpedance parameter used for nutritional assessment and evaluating the risk of various diseases. The phase angle was calculated automatically by the BIA device from these two components according to the following formula: phase angle (°) = (reactance/resistance) × (180°/π). | 8 week | 
| Fibromyalgia Impact Questionnaire (S-FIQ) | The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state. | 8 week | 
| Diaphragm tickness | Diaphragm muscle thickness will be measured in mm by an ultrasound device | Change from baseline diaphragm muscle thickness at 8 weeks |