Aerobic Training on Lung Function in Fibromyalgia

NCT ID: NCT06647147

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2025-05-15

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.

Conditions

Fibromyalgia (FM); Respiration Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

40 women with fibromyalgia will participate in low to moderate intensity aerobic training plus diaphragmatic breathing exercises.

Group Type: ACTIVE_COMPARATOR

Aerobic training

Intervention Type: OTHER

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.

Diaphragmatic breathing exercises

Intervention Type: OTHER

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.

Control group

40 women with fibromyalgia will only participate in diaphragmatic breathing exercises.

Group Type: ACTIVE_COMPARATOR

Diaphragmatic breathing exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Middle East University

OTHER

Sponsor Role: lead

Responsible Party

Saher Lotfy El Gayar

Assistant Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Sayed Saif, Ph.D

Role: STUDY_DIRECTOR

National institute for Gerontology

Central Contacts

Saher Lotfy Elgayar, Ph.D

Role: CONTACT

saherlotfy020@gmail.com

+201020429911

Mohammed Youssef Elhamrawy, Ph.D

Role: CONTACT

dr_melhamrawy@yahoo.com

+201282805567

Other Identifiers

Aerobic Training

Identifier Type: -

Identifier Source: org_study_id