Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
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
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Impact dun Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre dAdultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor Essai contrôlé randomisé Multicentrique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAPASOM
Brief 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
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 andor 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 dieteticadapted 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
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 andor 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 dieteticadapted 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 andor 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 dieteticadapted 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
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 andor 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 dieteticadapted 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DR220270 | OTHER | Sponsor | None |