Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia
Inspiratory Muscle Training in Respiratory Capacity, Life Quality, Lumbar Pain, Phase Angle and Body Composition in Patients With Fibromyalgia.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Pozuelo De Alarcón, Madrid, Spain, 28223
- Universidad Francisco de Vitoria
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- subjects with fibromyalgia
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inspiratory muscle training
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks.
Treatment as usual
|
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
|
|
No Intervention: No training program
Without inspiratory muscle training.
Treatment asusual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MIP
Time Frame: Change from baseline inspiratory muscle strength at 8 weeks]
|
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
Time Frame: 8 week
|
Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.
|
8 week
|
|
Pain :VAS
Time Frame: 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.
|
change from baseline after 8 week
|
|
phase angle
Time Frame: 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).
|
8 week
|
|
Fibromyalgia Impact Questionnaire (S-FIQ)
Time Frame: 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.
|
8 week
|
|
Diaphragm tickness
Time Frame: Change from baseline diaphragm muscle thickness at 8 weeks
|
Diaphragm muscle thickness will be measured in mm by an ultrasound device
|
Change from baseline diaphragm muscle thickness at 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fibro-UFV22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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