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Completed

NCT Number: NCT05362396

Inspiratory Muscle Training With Powerbreath Device 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects with fibromyalgia

Exclusion criteria

-

Treatment and study plan

Inspiratory Muscle Training with Powerbreath IMT device.

Other

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 outcomes

  1. 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

  2. Pain: Pressure algometry

    Time frame: 8 week

    Pain will be measured with pressure algometry measured in Kg from 0 to 5kg.

  3. 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.

  4. 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).

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 5, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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