Aerobic Training on Lung Function in Fibromyalgia

Impact of Aerobic Training on Lung Function in Women With Fibromyalgia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Respiration Disorders; Fibromyalgia (FM)
• Intervention / Treatment: Other: Aerobic training; Other: Diaphragmatic breathing exercises

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Lotfy Elgayar, Ph.D; Phone Number: +201020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Youssef Elhamrawy, Ph.D; Phone Number: +201282805567; Email: dr_melhamrawy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; 40 women with fibromyalgia will participate in low to moderate intensity aerobic training plus diaphragmatic breathing exercises.	Other: Aerobic training; For twelve weeks, the women in the study group will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down.; Other: Diaphragmatic breathing exercises; From the hook-lying position, the women will receive instructions to position their hands on the rectus abdominis muscle located under the anterior chest wall. They will be advised to inhale slowly and deeply, expanding their abdomen without causing any movement in their upper chest, while simultaneously relaxing their shoulders. Slowly, the women will expel every breath. Air will be inhaled via the nose, swelling the abdomen. After the breath ceased, the women will purse her lips and exhale from his mouth with half-opened lips and a hollow belly. A single respiratory cycle consists of a three-second intake, followed by a three-second pause, and concluding with a six-second expiration phase.
Active Comparator: Control group; 40 women with fibromyalgia will only participate in diaphragmatic breathing exercises.	Other: Diaphragmatic breathing exercises; From the hook-lying position, the women will receive instructions to position their hands on the rectus abdominis muscle located under the anterior chest wall. They will be advised to inhale slowly and deeply, expanding their abdomen without causing any movement in their upper chest, while simultaneously relaxing their shoulders. Slowly, the women will expel every breath. Air will be inhaled via the nose, swelling the abdomen. After the breath ceased, the women will purse her lips and exhale from his mouth with half-opened lips and a hollow belly. A single respiratory cycle consists of a three-second intake, followed by a three-second pause, and concluding with a six-second expiration phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	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.	At baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest expansion	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.	At baseline and 12 weeks
Exercise capacity	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.	At baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Middle East University
• Investigators: Study Director: Mohammed Sayed Saif, Ph.D, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2024
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Respiration Disorders
• Other Study ID Numbers: Aerobic Training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No