NCT07129538

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,

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Familial Mediterranean Fever

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life

    it will assess fatigue perception

    it will be measured after 8 weeks

Secondary Outcomes (10)

  • cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life

    it will be measured after 8 weeks

  • sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life

    it will be measured after 8 weeks

  • general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life

    it will be measured after 8 weeks

  • six minute walk distance

    it will be measured after 8 weeks

  • Forced vital capacity

    it will be measured after 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

IMR group

EXPERIMENTAL

Familial mediterranean fever (FMF adolescents ) in this inspiratory muscle retraining group (IMR group) 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).. also this group will receive their prescribed colchicine medications daily

Other: inspiratory muscle retraining

control group

OTHER

Familial mediterranean fever (FMF adolescents ) will be group of FMF will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily

Other: colchicine only

Interventions

inspiratory muscle retrainingOTHER

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

IMR group
colchicine onlyOTHER

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

control group

Eligibility Criteria

Age13 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ismail, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

May 10, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

EG(1)