Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: Inspiratory Muscle Training with Powerbreath IMT device.
- Registration Number
- NCT05362396
- Lead Sponsor
- Universidad Francisco de Vitoria
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- subjects with fibromyalgia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inspiratory muscle training Inspiratory Muscle Training with Powerbreath IMT device. Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
- Primary Outcome Measures
Name Time Method Pain :VAS change from baseline after 8 week Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
phase angle 8 week 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).
Fibromyalgia Impact Questionnaire (S-FIQ) 8 week 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.
MIP Change from baseline inspiratory muscle strength at 8 weeks] Maximum Inspiratory Pressure. Inspiratory muscle strength will be measured in % by a POWER-breathe device
Pain: Pressure algometry 8 week Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.
Diaphragm tickness Change from baseline diaphragm muscle thickness at 8 weeks Diaphragm muscle thickness will be measured in mm by an ultrasound device
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universidad Francisco de Vitoria
🇪🇸Pozuelo De Alarcón, Madrid, Spain