Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT04553094
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome
Sponsor:
French Cardiology Society
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome
Status:
COMPLETED
Status Verified Date:
2022-09
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:
MARF'HOME
Brief Summary:
Marfan syndrome (MS) is an autosomal dominant genetic disorder caused by a mutation in the fibrillin-1 gene (FBN1) encoding the protein fibrillin-1. Fibrillin is the main component of microfibrils, elements found in all of the body's tissues, and this pathology is characterized by the multitude of its clinical manifestations. These patients may develop aneurysms in the aortic root and one of the main factors of morbidity in patients with MS is aortic dissection. Prevention mainly involves preventive aortic surgery. However, the repercussions are global and can affect the functioning of other tissues such as skeletal muscle tissue, bone tissue, lung tissue and the eyes. The association of skeletal (scoliosis, hyperlaxity), muscular and ocular disorders is clearly associated with an impairment in the quality of life. These disorders are associated with pain and disability which affect professional activity, leisure and family life.
Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.
Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.
Detailed Description:
The main objective is to show that the quality of life of patients with Marfan syndrome can be improved by personalized training at home. The goal is to be able to offer new non-drug management based on physical activity to these patients.
Improved quality of life; Improvement of muscle strength by a muscle strengthening protocol; Improvement of cardiovascular function parameters. Regular coaching throughout the study.
1. / Assessment of muscular capacities
2. / Assessment of cardiovascular and respiratory capacities
3. / Response to psychometric questionnaires
4. / Participation in a training circuit (training protocol)
Improved quality of life; Improvement of muscle strength by a muscle strengthening protocol; Improvement of cardiovascular function parameters. Regular coaching throughout the study.
1. / Assessment of muscular capacities
2. / Assessment of cardiovascular and respiratory capacities
3. / Response to psychometric questionnaires
4. / Participation in a training circuit (training protocol)
Study Oversight
Has Oversight DMC:
False
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?: