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Outcomes of Inspiratory Muscle Training in FMF Adolescents

Outcomes of Inspiratory Muscle Training in FMF Adolescents

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07129538
Enrollment
40
Registered
2025-08-19
Start date
2025-05-10
Completion date
2025-09-15
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Mediterranean Fever

Brief summary

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

OTHERinspiratory 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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* cardiac problems * renal problems * liver problems * diabetes * brain problems

Design outcomes

Primary

MeasureTime frameDescription
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of lifeit will be measured after 8 weeksit will assess fatigue perception

Secondary

MeasureTime frameDescription
sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of lifeit will be measured after 8 weeksit will assess fatigue perception during sleep and rest
general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of lifeit will be measured after 8 weeksit will assess general fatigue perception
six minute walk distanceit will be measured after 8 weeksit will assess distance covered by FMF patients in six minutes of ongoing walking
Forced vital capacityit will be measured after 8 weeksit is a pulmonary capacity test
cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of lifeit will be measured after 8 weeksit will assess cognitive fatigue perception
Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacityit will be measured after 8 weeksit is a pulmonary function testing
maximum inhalation pressureit will be measured after 8 weeksit is indicator for inspiratory muscular strength
physical sum of child health qestionnaireit will be measured after 8 weeksit is an indiactor for physical quality of life
mental sum of child health qestionnaireit will be measured after 8 weeksit is an indiactor for mental quality of life
Forced exhalation volume (at first second of exhalation)it will be measured after 8 weeksit is a pulmonary function testing

Countries

Egypt

Contacts

Primary ContactAli MA Ismail, lecturer
ali.mohamed@pt.cu.edu.eg01005154209
Backup ContactIsmail, lecturer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026