ClinicalTrials.gg
Not yet recruitingNCT06647147Updated Oct 17, 2024

Aerobic Training on Lung Function in Fibromyalgia

An interventional study of Aerobic training and Diaphragmatic breathing exercises in Fibromyalgia (FM) and Respiration Disorders, sponsored by Middle East University. Not yet recruiting. Open to female participants aged 30 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Middle East University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Fibromyalgia (FM)
  • Respiration Disorders
03

In context

Fibromyalgia

1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Middle East University is the lead sponsor of 19 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any chest diseases.
  • Musculoskeletal/ neurological limitations to exercise.
  • Smokers.
  • Pregnant.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Study group

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

    Other: Aerobic training · Other: Diaphragmatic breathing exercises

  • Active comparator
    Control group

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

    Other: Diaphragmatic breathing exercises

Interventions

  • OtherAerobic 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.

  • OtherDiaphragmatic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline and 12 weeks

Secondary outcomes

  1. 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.

    Time frame: At baseline and 12 weeks

  2. 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.

    Time frame: At baseline and 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06647147
Lead sponsor
Middle East University
Responsible party
Saher Lotfy El Gayar (Assistant Professor of Physiotherapy, Kasr El Aini Hospital) — Principal investigator
First posted
Oct 17, 2024
Start date
Nov 25, 2024 (estimated)
Primary completion
Mar 20, 2025 (estimated)
Completion
May 15, 2025 (estimated)
Last update
Oct 17, 2024

Study contacts

Saher Lotfy Elgayar, Ph.D
Contact
saherlotfy020@gmail.com
+201020429911
Mohammed Youssef Elhamrawy, Ph.D
Contact
dr_melhamrawy@yahoo.com
+201282805567
Mohammed Sayed Saif, Ph.D
study director · National institute for Gerontology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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