Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

NCT05362396 | Completed

• 1 other identifier: Fibro-UFV22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (6)

• 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]

• Pain: Pressure algometry

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

  8 week

• 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

• 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).

  8 week

• 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

• Diaphragm tickness

  Diaphragm muscle thickness will be measured in mm by an ultrasound device

  Change from baseline diaphragm muscle thickness at 8 weeks

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

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

Other: Inspiratory Muscle Training with Powerbreath IMT device.

No training program

NO INTERVENTION

Without inspiratory muscle training. Treatment asusual.

Interventions

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

Inspiratory muscle training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with fibromyalgia

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Davinia Vicente Campos, PhD

  Universidad Francisco de Vitoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

ES (1)