Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Marfan Syndrome Moderate Exercise Pilot

NCT04641325

Marfan Syndrome

COMPLETED NA

Myotonic Dystrophy Type 1 Aerobic Exercise Study

NCT04187482

Myotonic Dystrophy 1 Muscular Dystrophies

COMPLETED NA

Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With FSHD : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.

NCT01689480

Muscular Dystrophy, Facioscapulohumeral

COMPLETED

Natural History of Cardiac and Respiration Function in Patients With Muscular Dystrophies on Home Mechanical Ventilation

NCT02501083

Heart, Respiratory, Disease, Functional

UNKNOWN

Resistance Exercise in Barth Syndrome

NCT01629459

Barth Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Marfan Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups of physical training intervention compared with control group

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

No physical training

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Endurance training

Group Type EXPERIMENTAL

Endurance training

Intervention Type OTHER

Aerobic circuit training

Group 3

Muscle building training

Group Type EXPERIMENTAL

Muscle building training

Intervention Type OTHER

Muscle strengthening circuit training

Group 4

Training combining endurance + muscle building

Group Type EXPERIMENTAL

Endurance training

Intervention Type OTHER

Aerobic circuit training

Muscle building training

Intervention Type OTHER

Muscle strengthening circuit training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endurance training

Aerobic circuit training

Intervention Type OTHER

Muscle building training

Muscle strengthening circuit training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patient with Marfan syndrome and followed up at Bichat Claude Bernard hospital, Paris. Marfan syndrome should be diagnosed according to the Ghent nosology revised in 2010
* Patient taking protective treatment for the aorta (beta blocker, calcium channel blocker, ACE inhibitor, angiotensin II receptor antagonist).
* Valid patient, able to return to consultation and carry out functional assessments and personalized physical training at home.
* Patients operated prophylactically on the ascending aorta may be included at a distance \> 6 months from their surgery.

Exclusion Criteria

* Myocardial pathology other than Marfan syndrome.
* Thoracic aorta dissection.
* Aortic diameter \> 45 millimeters.
* Uncontrolled high blood pressure at rest (systolic blood pressure \> 140 Millimeter of mercury and diastolic blood pressure \> 90 Millimeter of mercury)
* Increase in systolic blood pressure \> 160 Millimeter of mercury during exercise.
* Pregnancy at the time of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No