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Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory Muscle Training with Powerbreath IMT device.
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects with fibromyalgia

Exclusion Criteria:

-

Sites / Locations

  • Universidad Francisco de Vitoria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inspiratory muscle training

No training program

Arm Description

Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual

Without inspiratory muscle training. Treatment asusual.

Outcomes

Primary Outcome Measures

MIP
Maximum Inspiratory Pressure. Inspiratory muscle strength will be measured in % by a POWER-breathe device
Pain: Pressure algometry
Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.
Pain :VAS
Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
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).
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.
Diaphragm tickness
Diaphragm muscle thickness will be measured in mm by an ultrasound device

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
September 1, 2022
Sponsor
Universidad Francisco de Vitoria
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1. Study Identification

Unique Protocol Identification Number
NCT05362396
Brief Title
Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia
Official Title
Inspiratory Muscle Training in Respiratory Capacity, Life Quality, Lumbar Pain, Phase Angle and Body Composition in Patients With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Treatment as usual
Arm Title
No training program
Arm Type
No Intervention
Arm Description
Without inspiratory muscle training. Treatment asusual.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training with Powerbreath IMT device.
Intervention Description
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
Primary Outcome Measure Information:
Title
MIP
Description
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]
Title
Pain: Pressure algometry
Description
Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.
Time Frame
8 week
Title
Pain :VAS
Description
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
Title
phase angle
Description
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
Title
Fibromyalgia Impact Questionnaire (S-FIQ)
Description
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
Title
Diaphragm tickness
Description
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Time Frame
Change from baseline diaphragm muscle thickness at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects with fibromyalgia Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davinia Vicente Campos, PhD
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

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Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

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