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Recruiting NCT07129538

Outcomes of Inspiratory Muscle Training in FMF Adolescents

No phase Interventional Familial Mediterranean Fever

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inspiratory muscle retraining, colchicine only.
Who it may be relevant to
Registry conditions: Familial Mediterranean Fever. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance,

Detailed description

Familial mediterranean fever (FMF adolescents ) will be collected to be cateogarized to inspiratory muscle retraining group (IMR group) or control waitlist grouping. every group OF FMF will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. both groups will receive their prescribed colchicine medications daily

Interventions

  • Other inspiratory muscle retraining
    Familial mediterranean fever (FMF adolescents ) will be inspiratory muscle retraining group (IMR group) that will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. this group will receive their prescribed colchicine medications daily
  • Other colchicine only
    Familial mediterranean fever (FMF adolescents ) will be collected in this group OF FMF that will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily for eight weeks

Primary outcome measures

  • Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life [Time frame: it will be measured after 8 weeks]
Secondary outcome measures (10)
  • cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life [Time frame: it will be measured after 8 weeks]
  • sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life [Time frame: it will be measured after 8 weeks]
  • general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life [Time frame: it will be measured after 8 weeks]
  • six minute walk distance [Time frame: it will be measured after 8 weeks]
  • Forced vital capacity [Time frame: it will be measured after 8 weeks]
  • Forced exhalation volume (at first second of exhalation) [Time frame: it will be measured after 8 weeks]
  • Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacity [Time frame: it will be measured after 8 weeks]
  • maximum inhalation pressure [Time frame: it will be measured after 8 weeks]
  • physical sum of child health qestionnaire [Time frame: it will be measured after 8 weeks]
  • mental sum of child health qestionnaire [Time frame: it will be measured after 8 weeks]

Eligibility criteria

Inclusion criteria

  • FMF adolecents
  • ages 13 -17 years
  • forty patients

Exclusion criteria

  • cardiac problems
  • renal problems
  • liver problems
  • diabetes
  • brain problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of physical therapy — Giza

Identifiers

NCT: NCT07129538 · IRB00014233-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗