Aerobic Training on Lung Function in Fibromyalgia

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia (FM); Respiration Disorders

• Registration Number: NCT06647147
• Lead Sponsor: Middle East University

Brief Summary

Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.

Detailed Description

Eighty women with fibromyalgia will be equally randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. The Ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the CON will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. The lung functions will be assessed by the spirometry testing. The chest expansion will be determined using a tape measurement. Additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. All the outcomes will be examined at baseline, and after 12 weeks of the intervention.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2024-11-25
• Primary Completion: 2025-03-20
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Well controlled fibromyalgia.
• Mild restrictive lung affection.
• Body mass index less than 30kg/m2.
• Moderate level of physical activity.

Exclusion Criteria

• Any chest diseases.
• Musculoskeletal/ neurological limitations to exercise.
• Smokers.
• Pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lung function	At baseline and 12 weeks	Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second will be measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.

Secondary Outcome Measures

Name	Time	Method
Chest expansion	At baseline and 12 weeks	A centimeter tape measure will be used to assess chest expansion, and all measurements will be taken with the patients adopting a straight posture while standing. Two levels of chest expansion will be measured, the axillary level will be evaluated for upper chest expansion assessment, and the xyphoid level will be evaluated for lower chest expansion assessment.
Exercise capacity	At baseline and 12 weeks	Cardiopulmonary exercise test will be conducted for all women at baseline and post-study based on the guidelines set by the American College of Sports Medicine to determine VO2max for each women.