Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362396
• Other study ID #: Fibro-UFV22
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• subjects with fibromyalgia

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Inspiratory Muscle Training with Powerbreath IMT device.
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

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	Pain: Pressure algometry	Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.	8 week
Primary	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
Primary	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°/p).	8 week
Primary	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
Primary	Diaphragm tickness	Diaphragm muscle thickness will be measured in mm by an ultrasound device	Change from baseline diaphragm muscle thickness at 8 weeks