Actively Recruiting
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
On this page
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
Eligibility Criteria
You may qualify if you...
- Adolescents aged 13 to 17 years
- Diagnosed with familial Mediterranean fever (FMF)
- Total of 40 participants to be enrolled
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
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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