Cystic FibrosisDIAPASOMNCT06457451
Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial
A study testing DIAPASOM program in people with Cystic Fibrosis, run by University Hospital, Tours at 4 sites in France.
Trial summary
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- DIAPASOM program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arnaud DE LUCA, MD contact
France4 sites, 4 recruiting
- Recruiting
Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers
Angers, 49033
Pascaline PRIOU, MD
Pascaline PRIOU, MD
- Recruiting
Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff
Roscoff, 29684
Sophie RAMEL, MD
Sophie RAMEL, MD
- Recruiting
Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours
Tours, 37044
Julie MANKIKIAN, MD
Julie MANKIKIAN, MD
- Recruiting
Cystic Fibrosis Resource and Competence Centre, Hospital, Tours
Vannes, 56017
Baptiste ARNOUAT, MD
Baptiste ARNOUAT, MD
About this study
Official title: Impact d'un Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre d'Adultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor : Essai contrôlé randomisé Multicentrique
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.
Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.
Read more
In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.
Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.
Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.
Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.
Read the detailed description
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.
Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.
In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.
Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.
Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.
Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.
- Conditions
- Cystic Fibrosis
- Being tested
- DIAPASOM program
- Keywords
- Elexacaftor-Tezacaftor-Ivacaftor, Cystic Fibrosis, Adapted Physical Activity, Body composition, Dietetic
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAPASOM programOther
A program of adapted physical activity carried out remotely by a specialist instructor, combined with personalized dietetic care by a dietician for one year.
| Study group | Role | What they receive |
|---|---|---|
| DIAPASOM program | Experimental | Program of adapted physical activity carried out remotely by a specialized instructor for one year:
* Phase 1 (3 months): 2 supervised weekly sessions.
* Phase 2 (3months): 1 supervised weekly session and 1 independent weekly session.
* Phase 3 (6months): 2 independent weekly sessions with monthly telephone follow-up.
Combined with personalized dietetic care by a dietician for one year too:
In person dietetic consultation every 3 months to monitor personalized objectives, with telephone follow-up between each face-to-face consultation to improve compliance. Receives: Other: DIAPASOM program |
| Management as usual | No intervention | Management of nutrition and physical activity as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of percentage of patients lean mass as a percentage of body mass
Impedancemetry
Measured: From randomization, up to 12 months
Secondary outcomes (16)
Evolution of percentage of patients fat mass as a percentage of body mass
impedancemetry
Measured: From randomization, up to 12 months
Weight evolution
Weight measurement
Measured: From randomization, up to 12 months
Body Mass Index (BMI) evolution
Weight and height measurement
Measured: From randomization, up to 12 months
Cardio-respiratory endurance
6-Minute Walk Test (6MWT)
Measured: From randomization, up to 12 months
Bilateral Handgrip strength
Handgrip Test
Measured: From randomization, up to 12 months
Lower limb muscle power
30-second Sit-to-Stand test
Measured: From randomization, up to 12 months
Upper limb muscle power
Pump test
Measured: From randomization, up to 12 months
Static trunck extensors muscle endurance
"Superman" test
Measured: From randomization, up to 12 months
Static trunck flexors muscle endurance
Shirado-Ito test
Measured: From randomization, up to 12 months
Balance between static muscular endurance of extensors and flexors
Calculated using the Shirado-Ito/"Superman" ratio
Measured: From randomization, up to 12 months
Posterior chain flexibility (Hamstring, hips and lower back)
Front trunk flexion test
Measured: From randomization, up to 12 months
Upper limb flexibility
scapulohumeral mobility test
Measured: From randomization, up to 12 months
Forced Expiratory Volume in 1 second (FEV1)
Spirometry
Measured: From randomization, up to 12 months
Physical activity volume and sedentary time
Physical activity and sedentary behavior self-questionnaire (ONAPS-PAQ)
Measured: From randomization, up to 12 months
Evolution of quality of life
Cystic Fibrosis Questionnaire-Revised (CFQR-14)
Measured: From randomization, up to 12 months
Program feedback questionnaire
Self-questionnaire about how patients in the experimental group feel about the program
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Ildys
- Responsible party
- Sponsor
- Investigators
- Julie MANKIKIAN, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457451
- Sponsor's protocol ID
- 2023-A02715-40
- Other IDs
- DR220270
- Acronym
- DIAPASOM
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact d'un Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre d'Adultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor : Essai contrôlé randomisé Multicentrique
- ClinicalTrials.gov ID
- NCT06457451
- Acronym / sponsor ID
- DIAPASOM / 2023-A02715-40
- Conditions
- Cystic Fibrosis
- Keywords
- Elexacaftor-Tezacaftor-Ivacaftor, Cystic Fibrosis, Adapted Physical Activity, Body composition, Dietetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Fondation Ildys
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.
Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.
In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.
Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.
Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.
Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.
Detailed description
Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.
Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.
In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.
Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.
Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.
Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIAPASOM program | Experimental | Other: DIAPASOM programProgram of adapted physical activity carried out remotely by a specialized instructor for one year: * Phase 1 (3 months): 2 supervised weekly sessions. * Phase 2 (3months): 1 supervised weekly session and 1 independent weekly session. * Phase 3 (6months): 2 independent weekly sessions with monthly telephone follow-up. Combined with personalized dietetic care by a dietician for one year too: In person dietetic consultation every 3 months to monitor personalized objectives, with telephone follow-up between each face-to-face consultation to improve compliance. |
| Management as usual | No intervention | –Management of nutrition and physical activity as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIAPASOM programA program of adapted physical activity carried out remotely by a specialist instructor, combined with personalized dietetic care by a dietician for one year. | Other | DIAPASOM program |
Primary outcome
Evolution of percentage of patients lean mass as a percentage of body mass
Time frame: From randomization, up to 12 months
Impedancemetry
16 secondary outcomes
Evolution of percentage of patients fat mass as a percentage of body mass
Time frame: From randomization, up to 12 months
Weight evolution
Time frame: From randomization, up to 12 months
Body Mass Index (BMI) evolution
Time frame: From randomization, up to 12 months
Cardio-respiratory endurance
Time frame: From randomization, up to 12 months
Bilateral Handgrip strength
Time frame: From randomization, up to 12 months
Lower limb muscle power
Time frame: From randomization, up to 12 months
Upper limb muscle power
Time frame: From randomization, up to 12 months
Static trunck extensors muscle endurance
Time frame: From randomization, up to 12 months
Static trunck flexors muscle endurance
Time frame: From randomization, up to 12 months
Balance between static muscular endurance of extensors and flexors
Time frame: From randomization, up to 12 months
Posterior chain flexibility (Hamstring, hips and lower back)
Time frame: From randomization, up to 12 months
Upper limb flexibility
Time frame: From randomization, up to 12 months
Forced Expiratory Volume in 1 second (FEV1)
Time frame: From randomization, up to 12 months
Physical activity volume and sedentary time
Time frame: From randomization, up to 12 months
Evolution of quality of life
Time frame: From randomization, up to 12 months
Program feedback questionnaire
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud DE LUCA, MD contact
Julie MANKIKIAN, MD principal investigator
University Hospital, Tours
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIAPASOM program in people with Cystic Fibrosis, run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie GIBORY (0247474747 ext. +33, a.gibory@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of percentage of patients lean mass as a percentage of body mass (time frame: From randomization, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.