ClinicalTrials.gov record NCT07129538

Outcomes of Inspiratory Muscle Training in FMF Adolescents

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Outcomes of Inspiratory Muscle Training in FMF Adolescents

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age13 years old to 17 years old
SexAll
LocationEgypt
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A randomized interventional study enrolling adolescents (13–17 years) with Familial Mediterranean Fever (FMF). Participants are assigned to inspiratory muscle retraining (two sessions per day, five days per week) plus their prescribed colchicine, or to colchicine only, for eight weeks. The study measures fatigue, walking distance, lung function, inspiratory strength, and quality-of-life scores after 8 weeks.

What it is studying. Tests the effects of adding inspiratory muscle retraining to daily colchicine on fatigue, exercise tolerance, lung function, inspiratory strength, and quality of life in adolescents with FMF.

What the researchers hope to learn. Aims to measure whether inspiratory muscle retraining affects fatigue levels, six-minute walk distance, pulmonary function (FVC, FEV1, FEV1/FVC), maximal inhalation pressure, and physical and mental quality-of-life scores.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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,

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • inspiratory muscle retraining
  • colchicine only

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be randomly assigned to one of two groups for eight weeks. One group will do inspiratory muscle retraining (IMR): two IMR sessions per day, five days a week, with each session containing three sets of 10 breaths; the other group will receive colchicine only. Both groups will receive their prescribed colchicine medications daily. After the 8‑week period you will complete fatigue and quality‑of‑life questionnaires and perform physical tests such as a six‑minute walk and breathing tests (forced vital capacity, FEV1, FEV1/FVC ratio, and maximum inhalation pressure); the record does not list invasive procedures.

How the study is structured. Randomized, parallel-group interventional study. Adolescents are randomly assigned to two groups for eight weeks: inspiratory muscle retraining plus their regular colchicine, or colchicine only. The study is single-masked. Key outcomes are measured after 8 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 10, 2025
Primary completion
Sep 15, 2025 (estimated)
Study completion
Sep 15, 2025 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Aug 19, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Cairo University
Principal investigator
Ali Mohamed Ali ismail, lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials