NCT06647147

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 16, 2024

Last Update Submit

October 16, 2024

Conditions

Fibromyalgia (FM)Respiration Disorders

Outcome Measures

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.

    At baseline and 12 weeks

Secondary Outcomes (2)

  • Chest expansion

    At baseline and 12 weeks

  • Exercise capacity

    At baseline and 12 weeks

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Other: Aerobic trainingOther: Diaphragmatic breathing exercises

Control group

ACTIVE COMPARATOR

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

Other: Diaphragmatic breathing exercises

Interventions

Aerobic trainingOTHER

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.

Study group
Diaphragmatic breathing exercisesOTHER

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 groupStudy group

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibromyalgiaRespiration Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesRespiratory Tract Diseases

Study Officials

  • Mohammed Sayed Saif, Ph.D

    National institute for Gerontology

    STUDY DIRECTOR

Central Study Contacts

Saher Lotfy Elgayar, Ph.D

CONTACT

+201020429911saherlotfy020@gmail.com

Mohammed Youssef Elhamrawy, Ph.D

CONTACT

+201282805567dr_melhamrawy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 17, 2024

Study Start

November 25, 2024

Primary Completion

March 20, 2025

Study Completion

May 15, 2025

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share