Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
ID07129538

Outcomes of Inspiratory Muscle Training in Adolescents with Familial Mediterranean Fever

Led by Cairo University · Updated on 2025-08-19

40

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This research focuses on adolescents aged 13 to 17 years with Familial Mediterranean Fever (FMF), a condition often diagnosed before age 18 and associated with reduced exercise tolerance, lung function, and fatigue tolerance. The study aims to evaluate the effects of inspiratory muscle retraining (IMR) on these symptoms in FMF adolescents. Participants will be randomly assigned to one of two groups: the IMR group or a control group. The IMR group will perform two inspiratory muscle retraining sessions daily, five days a week, for eight weeks. Each session includes three sets of training, with each set consisting of 10 breath cycles. Both groups will continue their prescribed daily colchicine medication throughout the eight-week period. During the study, researchers will assess fatigue levels using the Multidimensional Scale of Fatigue from the pediatric quality of life questionnaire after eight weeks. Additional measurements will include walking distance over six minutes, lung function tests, maximum inhalation pressure, and physical and mental health scores. The total participation duration is eight weeks, with evaluations conducted at the end of this period.

CONDITIONS

Brief Title

Outcomes of Inspiratory Muscle Training in FMF Adolescents

Who Can Participate

Age: 13Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents aged 13 to 17 years
  • Diagnosed with familial Mediterranean fever (FMF)
  • Total of 40 participants to be enrolled
Not Eligible

You will not qualify if you...

  • Presence of cardiac problems
  • Presence of renal (kidney) problems
  • Presence of liver problems
  • Diagnosis of diabetes
  • Presence of brain problems

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants are assigned to either the inspiratory muscle retraining group or the control group and receive their respective interventions alongside daily colchicine medication.

Two IMR sessions daily, five times weekly for the IMR group; colchicine medication daily for all participants

Follow-up

Duration - 1 day

Participants are assessed for various fatigue, physical, and respiratory outcomes after completing the treatment period.

1 visit (in-person) for outcome assessment after 8 weeks

Trial Site Locations

Total: 1 location

1

Faculty of physical therapy

Giza, Dokki, Egypt

Actively Recruiting

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Research Team

A

Ali MA Ismail, lecturer

I

Ismail, lecturer

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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