An interventional study of Inspiratory Muscle Training with Powerbreath IMT device. in Fibromyalgia, sponsored by Universidad Francisco de Vitoria. Completed at 1 site in Spain. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Universidad Francisco de Vitoria · Not applicable, Interventional, and Treatment
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universidad Francisco de Vitoria is the lead sponsor of 52 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Other: Inspiratory Muscle Training with Powerbreath IMT device.
Without inspiratory muscle training. Treatment asusual.
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
MIP
Maximum Inspiratory Pressure. Inspiratory muscle strength will be measured in % by a POWER-breathe device
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 8 week
Diaphragm tickness
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Time frame: Change from baseline diaphragm muscle thickness at 8 weeks
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Universidad Francisco de Vitoria