Marfan SyndromeNCT05809323
Marfan Syndrome Moderate Exercise Trial II
A study testing Exercise Intervention Group in people with Marfan Syndrome, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Exercise Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Jul 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)
- Age 10-25 years at enrollment
Who cannot join
- History of aortic surgery
- History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.
- Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)
- Condition limiting the ability to perform moderate exercise.
- Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures.
- Aortic dilation meeting threshold for prophylactic aortic surgical intervention (>/= 4.5 cm in diameter)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Shaine A Morris, MD MPH, 832-826-5682, shainem@bcm.edu
Jennifer Bogardus, PT, MPT, PhD, 713-794-2070, jbogardus@twu.edu
About this study
Official title: Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome
Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.
Read the detailed description
Marfan syndrome (MFS) is a distinctive connective tissue disorder with clinical phenotypes that affect multiple organ systems including the heart, bones, ligaments, and eyes, and are associated with significant risk of aortic dissection. Given anecdotal reports of aortic dissection, limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities, most commonly isometric exercise and contact sports. Published guidelines also suggest restriction from highly dynamic competitive sports. While clinicians may mean to restrict patients only from competitive sports, often children and families interpret this caution as applying to almost all exercise, resulting in a large number of patients with MFS being sedentary. This lack of exercise and deconditioning likely has detrimental effects in increasing weakness and joint pain and decreasing endurance. Depressive symptoms are also not uncommon in patients with these syndromes, and may be triggered or exacerbated by guidance to acutely cease participation in sports at the time of diagnosis.
To date, as far as we are aware, there are no published controlled studies on the effects of dynamic exercise on human subjects. In 2017, Mas-Stachurska et al published a study suggesting that a moderate level of dynamic exercise mitigated progressive degradation of the cardiac structures typically seen in MFS in a rodent sample. This study suggests the possibility that the fears surrounding moderate exercise in humans may be unwarranted. In addition, this study suggests that moderate exercise may actually protect the aorta and myocardium, in addition to the numerous other physical and emotional benefits that have been shown to result from consistent exercise. We have unpublished trial results in a pilot study that also suggest benefit to adolecents and young adults.
Given the significant paucity of data currently existing on effects of exercise in humans with MFS, and the recent optimistic findings in rodent models, we plan to conduct a randomized control trial of moderate dynamic exercise in adolescents and young adults with MFS.
The objective is to:
- Randomize 50 patients with Marfan syndrome from ages 10-25 years to current status and care (controls) versus a moderate dynamic exercise intervention, then 2) allow the control group patients to undergo the exercise intervention.The investigators will then compare outcomes between both the intervention and control groups, and between the baseline and post-intervention states. Specific outcome measures will include cardiovascular assessment: maximal oxygen uptake (max VO2), ambulatory blood pressure, segmental and central aortic stiffness, ventricular mass and volume, and endothelial function, physical assessment by the physical therapist, and quality of life/mental health assessment: health-related quality of life, depression and anxiety screening scales. The hypothesis is that the intervention of a moderate exercise program introduced by a licensed physical therapist will result in improvement in cardiovascular status, muscular health, and mental health without detrimental effects on the aortic wall.
- Conditions
- Marfan Syndrome
- Being tested
- Exercise Intervention Group, Control Group
- Keywords
- Cardiovascular, Moderate Exercise, Physical Therapy
- Medical subject headings
- Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention GroupOther
Patients will be educated on methods of self-evaluating exertion and cardiovascular effort by assessing respiratory rate and perceived exertion. Next, patients will be given options for cardiovascular activities and complete at a moderate level of activity for a minimum of 150 minutes per week. Patients will perform a combination of exercises under the supervision of a physical therapist until a mod intensity level is reached and sustained. Patients will be taught to use the activity tracker to record their heart rate, activity, and PES. Patients will have a phone call every week to assess status, answer questions, and provide guidance on progressing intensity or duration of exercise. At the end of 12 weeks all patients will return for re-assessment.
Control GroupOther
Also called No Intervention
Patients in the control group will be instructed to continue with baseline physical activities over the duration of the study and be given instructions on the use of the activity tracker. At the end of 12 weeks all patients will return for re-assessment.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group | Experimental | Group of up to 50 patients will randomly allocated into an experimental group at a 4:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) in addition to exercise intervention education, demonstration, and follow up to ensure compliance and safety. Receives: Other: Exercise Intervention Group |
| Control Group | Other | Control group will be randomly allocated at a 4:1 ratio, intervention to controls.. The control group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) and will be instructed to continue with baseline physical activities. They will be asked to return for a reassessment of all baseline procedures (cardiovascular, musculoskeletal, and psychological screening). Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum VO2
Maximum VO2 in ml/kg/minute will be collected via Exercise Stress Test. Range 30-85, higher is better.
Measured: 4 Months
Secondary outcomes (27)
Mean systolic blood pressure
mmHg, range 20-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
Measured: 4 Months
Mean diastolic blood pressure
mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
Measured: 4 Months
Mean pulse pressure
mmHg, systolic blood pressure minus diastolic blood pressure, range 30-70 mmHg, goal is normal range for age and sex
Measured: 4 Months
Weight
kg, range 50-300kg, lower is better, excluding underweight patients
Measured: 4 Months
BMI
kg/m2, lower is better generally, excluding pts with BMI <5% for age
Measured: 4 Months
Left ventricular strain by cardiac MRI
Continuous measure derived from post-processing MRI
Measured: 4 Months
Right ventricular strain by cardiac MRI
Continuous measure derived from post-processing MRI
Measured: 4 Months
Aortic root strain
Continuous measure %, higher is less stiff, Range 0-40
Measured: 4 Months
Aortic Root Distensibility
×10-3 mm Hg-1, Continuous measure, range 0.1-10
Measured: 4 Months
Aortic Root β-Stiffness index
No units, Range 0.1-90
Measured: 4 Months
Maximum aortic root dimension
Measured in cm, range 1-8cm
Measured: 4 Months
Aortic root z-score
No units, based on body surface area published references, range -3 to 25
Measured: 4 Months
Aortic pulse wave velocity from MRI
meters/second, range 0-30
Measured: 4 Months
Pulse wave velocity derived from applanation tonometry
meters/second, range 0-30
Measured: 4 Months
Quality of Life Scale (QOLS) (ages 19-21 y)
16 items, each with 7 point Likert, higher is worse
Measured: 4 Months
Pediatric Quality of Life Scale (PedsQL) scale scores
reported in 3 domains, each reported on Likert scale, scaled to 0-100 scale, lower is worse
Measured: 4 Months
Patient Health Questionnaire-9 (PHQ-9)
Nine-item questionnaire that detects depression and the severity of the depression, scaled from 0-27, higher is worse
Measured: 4 Months
Patient Health Questionnaire-4 (PHQ-4) Subset A: Anxiety
Four-question test for anxiety and depression, scaled from 0-12 Subset A (Anxiety): Questions 1 \& 2, which have a total PHQ 4 score range of 0 to 6. A score of 3 or greater is considered positive for screening purposes.
Measured: 4 Months
Patient Health Questionnaire-4 (PHQ-4) Subset B: Depression
Four-question test for anxiety and depression, scaled from 0-12, Subset B (Depression): Questions 3 \& 4, which have a total PHQ 4 score range of 0 to 6. A score of 3 or greater is considered positive for screening purposes.
Measured: 4 Months
Generalized Anxiety Disorder 7-item (GAD-7)
Seven-item questionnaire that detects generalized anxiety disorder and the severity of the anxiety. GAD-7 total score for the seven items ranges from 0 to 21. Using a cut-off of 8 the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis generalized anxiety disorder.
Measured: Every 2 Weeks for 4 Months
Pediatric Symptom Checklist Parent (PSC)
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English \& Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
Measured: 4 Months
Pediatric Symptom Checklist Child (PSC-Y)
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English \& Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
PSC Subscales:
Attention Problems, Internalizing Problems, Externalizing Problems
Measured: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Attention Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English \& Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
PSC Subscales:
Attention Problems Subscale: Children with subscores greater than or equal to 7 usually have significant impairments in attention.
Measured: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Internalizing Problems Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English \& Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
PSC Subscales:
Internalizing Problems Subscale: Children with subscores greater than or equal to 5 usually have significant impairments with anxiety or depression.
Measured: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Externalizing Problems Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English \& Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
PSC Subscales:
Externalizing Problems Subscale: Children with subscores greater than or equal to 7 usually have significant problems with conduct.
Measured: 4 Months
PROMIS Pediatric Self- Reported Psychological Stress
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Better health is a lower score and worse health scores higher.
Measured: 4 Months
PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher score is worse health.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Sep 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study will be conducted as a parallel study model, with 2 groups in total: Exercise Intervention Group (interventional group) and Current Care Group (control group). Baseline and follow up testing will occur in both groups at identical time intervals.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Star Research
- Responsible party
- Principal investigator, Shaine Morris, Baylor College of Medicine
- Investigators
- Shaine A Morris, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809323
- Sponsor's protocol ID
- H-53417
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome
- ClinicalTrials.gov ID
- NCT05809323
- Acronym / sponsor ID
- H-53417
- Conditions
- Marfan Syndrome
- Keywords
- Cardiovascular, Moderate Exercise, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Southern Star Research
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Apr 2023 (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.
Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.
Detailed description
Marfan syndrome (MFS) is a distinctive connective tissue disorder with clinical phenotypes that affect multiple organ systems including the heart, bones, ligaments, and eyes, and are associated with significant risk of aortic dissection. Given anecdotal reports of aortic dissection, limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities, most commonly isometric exercise and contact sports. Published guidelines also suggest restriction from highly dynamic competitive sports. While clinicians may mean to restrict patients only from competitive sports, often children and families interpret this caution as applying to almost all exercise, resulting in a large number of patients with MFS being sedentary. This lack of exercise and deconditioning likely has detrimental effects in increasing weakness and joint pain and decreasing endurance. Depressive symptoms are also not uncommon in patients with these syndromes, and may be triggered or exacerbated by guidance to acutely cease participation in sports at the time of diagnosis.
To date, as far as we are aware, there are no published controlled studies on the effects of dynamic exercise on human subjects. In 2017, Mas-Stachurska et al published a study suggesting that a moderate level of dynamic exercise mitigated progressive degradation of the cardiac structures typically seen in MFS in a rodent sample. This study suggests the possibility that the fears surrounding moderate exercise in humans may be unwarranted. In addition, this study suggests that moderate exercise may actually protect the aorta and myocardium, in addition to the numerous other physical and emotional benefits that have been shown to result from consistent exercise. We have unpublished trial results in a pilot study that also suggest benefit to adolecents and young adults.
Given the significant paucity of data currently existing on effects of exercise in humans with MFS, and the recent optimistic findings in rodent models, we plan to conduct a randomized control trial of moderate dynamic exercise in adolescents and young adults with MFS.
The objective is to:
- Randomize 50 patients with Marfan syndrome from ages 10-25 years to current status and care (controls) versus a moderate dynamic exercise intervention, then 2) allow the control group patients to undergo the exercise intervention.The investigators will then compare outcomes between both the intervention and control groups, and between the baseline and post-intervention states. Specific outcome measures will include cardiovascular assessment: maximal oxygen uptake (max VO2), ambulatory blood pressure, segmental and central aortic stiffness, ventricular mass and volume, and endothelial function, physical assessment by the physical therapist, and quality of life/mental health assessment: health-related quality of life, depression and anxiety screening scales. The hypothesis is that the intervention of a moderate exercise program introduced by a licensed physical therapist will result in improvement in cardiovascular status, muscular health, and mental health without detrimental effects on the aortic wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional study will be conducted as a parallel study model, with 2 groups in total: Exercise Intervention Group (interventional group) and Current Care Group (control group). Baseline and follow up testing will occur in both groups at identical time intervals.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Other: Exercise Intervention GroupGroup of up to 50 patients will randomly allocated into an experimental group at a 4:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) in addition to exercise intervention education, demonstration, and follow up to ensure compliance and safety. |
| Control Group | Other | Other: Control GroupControl group will be randomly allocated at a 4:1 ratio, intervention to controls.. The control group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) and will be instructed to continue with baseline physical activities. They will be asked to return for a reassessment of all baseline procedures (cardiovascular, musculoskeletal, and psychological screening). |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)
- Age 10-25 years at enrollment
Key exclusion criteria (6 listed)
- History of aortic surgery
- History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.
- Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)
- Condition limiting the ability to perform moderate exercise.
- Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures.
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 |
|---|---|---|
| Exercise Intervention GroupPatients will be educated on methods of self-evaluating exertion and cardiovascular effort by assessing respiratory rate and perceived exertion. Next, patients will be given options for cardiovascular activities and complete at a moderate level of activity for a minimum of 150 minutes per week. Patients will perform a combination of exercises under the supervision of a physical therapist until a mod intensity level is reached and sustained. Patients will be taught to use the activity tracker to record their heart rate, activity, and PES. Patients will have a phone call every week to assess status, answer questions, and provide guidance on progressing intensity or duration of exercise. At the end of 12 weeks all patients will return for re-assessment. | Other | Exercise Intervention Group |
| Control GroupAlso: No InterventionPatients in the control group will be instructed to continue with baseline physical activities over the duration of the study and be given instructions on the use of the activity tracker. At the end of 12 weeks all patients will return for re-assessment. | Other | Control Group |
Primary outcome
Maximum VO2
Time frame: 4 Months
Maximum VO2 in ml/kg/minute will be collected via Exercise Stress Test. Range 30-85, higher is better.
27 secondary outcomes
Mean systolic blood pressure
Time frame: 4 Months
Mean diastolic blood pressure
Time frame: 4 Months
Mean pulse pressure
Time frame: 4 Months
Weight
Time frame: 4 Months
BMI
Time frame: 4 Months
Left ventricular strain by cardiac MRI
Time frame: 4 Months
Right ventricular strain by cardiac MRI
Time frame: 4 Months
Aortic root strain
Time frame: 4 Months
Aortic Root Distensibility
Time frame: 4 Months
Aortic Root β-Stiffness index
Time frame: 4 Months
Maximum aortic root dimension
Time frame: 4 Months
Aortic root z-score
Time frame: 4 Months
Aortic pulse wave velocity from MRI
Time frame: 4 Months
Pulse wave velocity derived from applanation tonometry
Time frame: 4 Months
Quality of Life Scale (QOLS) (ages 19-21 y)
Time frame: 4 Months
Pediatric Quality of Life Scale (PedsQL) scale scores
Time frame: 4 Months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 4 Months
Patient Health Questionnaire-4 (PHQ-4) Subset A: Anxiety
Time frame: 4 Months
Patient Health Questionnaire-4 (PHQ-4) Subset B: Depression
Time frame: 4 Months
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Every 2 Weeks for 4 Months
Pediatric Symptom Checklist Parent (PSC)
Time frame: 4 Months
Pediatric Symptom Checklist Child (PSC-Y)
Time frame: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Attention Subscale
Time frame: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Internalizing Problems Subscale
Time frame: 4 Months
Pediatric Symptom Checklist Child (PSC-Y): Externalizing Problems Subscale
Time frame: 4 Months
PROMIS Pediatric Self- Reported Psychological Stress
Time frame: 4 Months
PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
Time frame: 4 Months
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 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Shaine A Morris, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention Group in people with Marfan Syndrome, run by Baylor College of Medicine at 1 site in United States.
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 2 inclusion and 6 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Shaine A Morris, MD, MPH (832-826-5692, shainem@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum VO2 (time frame: 4 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 24 Jan 2024.