Faculty of physical therapy
Giza, Dokki, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT07129538
Outcomes of Inspiratory Muscle Training in FMF Adolescents
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,
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
13 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- FMF adolecents
- ages 13 -17 years
- forty patients
Exclusion criteria
- cardiac problems
- renal problems
- liver problems
- diabetes
- brain problems
Treatment and study plan
inspiratory muscle retraining
OtherFamilial 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
colchicine only
OtherFamilial 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 outcomes
-
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life
Time frame: it will be measured after 8 weeks
it will assess fatigue perception
Secondary outcomes
-
cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
it will assess cognitive fatigue perception
-
sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
it will assess fatigue perception during sleep and rest
-
general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
it will assess general fatigue perception
-
six minute walk distance
Time frame: it will be measured after 8 weeks
it will assess distance covered by FMF patients in six minutes of ongoing walking
-
Forced vital capacity
Time frame: it will be measured after 8 weeks
it is a pulmonary capacity test
-
Forced exhalation volume (at first second of exhalation)
Time frame: it will be measured after 8 weeks
it is a pulmonary function testing
-
Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacity
Time frame: it will be measured after 8 weeks
it is a pulmonary function testing
-
maximum inhalation pressure
Time frame: it will be measured after 8 weeks
it is indicator for inspiratory muscular strength
-
physical sum of child health qestionnaire
Time frame: it will be measured after 8 weeks
it is an indiactor for physical quality of life
-
mental sum of child health qestionnaire
Time frame: it will be measured after 8 weeks
it is an indiactor for mental quality of life
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 19, 2025
- Registry last updated
- Aug 19, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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