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New program aims to boost muscle in cystic fibrosis patients on trikafta

NCT ID NCT06457451

Disease control Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a one-year program of remote exercise sessions and personalized diet advice can increase lean muscle mass in 100 adults with cystic fibrosis who are already taking the drug Trikafta. The program is designed to address new nutritional challenges, like weight gain and metabolic issues, that can arise with Trikafta. Researchers will measure changes in muscle mass, strength, and endurance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DIAPASOM program (dietary counseling and adapted physical activity)
What this could lead to
If successful, this program could help people with cystic fibrosis build and maintain muscle mass, improving their strength and overall health.
What could go wrong
This is a small, early-stage trial focused on a supportive therapy, not a cure. The program may not lead to significant muscle gain, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject aged 18 or over * Suffering from cystic fibrosis * Treated with Elexacaftor-Tezacaftor-Ivacaftor for at least 6 months * Affiliated to a social security scheme * with a signed Informed Consent form. Exclusion Criteria: * Pregnant and breast-feeding women * Subject under legal protection, guardianship or curatorship * Subject whose physical activity is not medically authorised or whose physical and motor capacities do not allow them to take part in physical activity. * Subject who is unable to comply with the requirements of the DIAPASOM program * Difficulty in understanding the self-questionnaires * Wearing a pacemaker or metal prosthesis * Fluid retention

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff

    RECRUITING

    Roscoff, 29684, France

  • Cystic Fibrosis Resource and Competence Centre, Hospital, Tours

    RECRUITING

    Vannes, 56017, France

  • Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers

    RECRUITING

    Angers, 49033, France

  • Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours

    RECRUITING

    Tours, 37044, France

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