NCT07130305

Brief Summary

Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass

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 8, 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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    it is a measure for bone density at 2-4 lumbar vertebrae

    it will be measured after 6 months

Secondary Outcomes (7)

  • z score

    it will be measured after 6 months

  • vitamin D

    it will be measured after 6 months

  • osteoprotegerin

    it will be measured after 6 months

  • quadriceps torque

    it will be measured after 6 months

  • Standing long jump test

    it will be measured after 6 months

  • +2 more secondary outcomes

Study Arms (2)

vibration group

EXPERIMENTAL

vibration group OF FMF will contain 20 FMF adolescent girls. who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive also three sessions of 20-min whole body vibration in the week for 6 months

Other: whole body vibration plus usual care

control group

ACTIVE COMPARATOR

control group of Familial mediterranean fever (20 FMF adolescent girls ) will receive vitamin D and their traditional colchicine doses daily for six months.

Other: usual care

Interventions

Familial mediterranean fever (20 FMF adolescent girls ) will be in this vibration group who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will also receive three sessions of 20-min whole body vibration in the week for 6 months

vibration group

Familial mediterranean fever (20 FMF adolescent girls ) will be in this control group who will receive vitamin D and their traditional colchicine doses daily for six months.

control group

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • FMF adolecent girls 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)

Cairo University

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

Ali Ismail

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
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 8, 2025

Primary Completion

January 8, 2026

Study Completion

January 15, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations