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The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.
The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sleep parameters | Experimental | To assess the sleep parameters. |
|
| cardiovascular parameters | Other | To assess the cardiovascular profile of control mothers and caregivers-mothers. |
|
| imflammatory and immunological profile | Experimental | To assess the inflammatory profile of caregivers-mothers and control mothers |
|
| hormonal profile | Experimental | To assess the hormonal profile of caregivers-mothers and control mothers. |
|
| metabolic profile | Experimental | To assess the health profile of caregivers-mothers and control mothers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sleep parameters | Biological | Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern. |
|
| Measure | Description | Time Frame |
|---|---|---|
| sleep patterns of the study population | Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Insulin Cortisol Luteinizing hormone (LH) Follicle-stimulating hormone (FSH) Total Testosterone Estradiol Progesterone Vitamin B12 Adrenocorticotropic hormone (ACTH) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Federal of São Paulo | São Paulo | São Paulo | 04024001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19160150 | Background | Donders J, Taneja C. Neurobehavioral characteristics of children with Duchenne muscular dystrophy. Child Neuropsychol. 2009 May;15(3):295-304. doi: 10.1080/09297040802665777. Epub 2009 Jan 22. | |
| 1512385 | Background | Draper BM, Poulos CJ, Cole AM, Poulos RG, Ehrlich F. A comparison of caregivers for elderly stroke and dementia victims. J Am Geriatr Soc. 1992 Sep;40(9):896-901. doi: 10.1111/j.1532-5415.1992.tb01986.x. |
| Label | URL |
|---|---|
| Sleep research society | View source |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D006854 | Hydrocortisone |
| D007986 | Luteinizing Hormone |
| D005640 | Follicle Stimulating Hormone |
| D013739 | Testosterone |
| D004958 | Estradiol |
| D011374 | Progesterone |
| D014805 | Vitamin B 12 |
| D000324 | Adrenocorticotropic Hormone |
| D002097 | C-Reactive Protein |
| D016133 | Polymerase Chain Reaction |
| D007070 | Immunoglobulin A |
| D007074 | Immunoglobulin G |
| D007075 | Immunoglobulin M |
| D003176 | Complement C3 |
| D003181 | Complement C4 |
| D015850 | Interleukin-6 |
| D016753 | Interleukin-10 |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Hormonal profile | Biological | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters. |
|
|
| Inflammatory profile | Biological | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters |
|
|
| Cardiovascular profile | Biological | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters |
|
|
| Metabolic profile | Biological | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters |
|
|
| Inflammatory profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: C-reactive protein (PCR) Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Complement (C3) Complement (C4) Interleukin 6 Interleukin 10 Interleukin 1β Interleukin 2 Interleukin 4 Interleukin 8 Interferon-gamma (IFN-γ) Endothelin Prostaglandin E2 Intercellular Adhesion Molecule 1 (ICAM) Vascular cell adhesion protein 1 (VCAM) Tumor necrosis factor (TNFα) Adiponectin Leptin Cysteine Lymphocytes subpopulations (T e B) | Baseline |
| Cardiovascular profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Homocysteine Myoglobin Cardiac troponin I Creatine kinase (CK) Creatine kinase MB (CKMB) | Baseline |
| Metabolic profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Glucose Total cholesterol and fractions Triglycerides Uric acid Creatinine Urea Sodium Potassium Hemogram Erythrocyte sedimentation rate Natriuretic Peptide B | Baseline |
| 22008789 | Background | Fee RJ, Hinton VJ. Resilience in children diagnosed with a chronic neuromuscular disorder. J Dev Behav Pediatr. 2011 Nov;32(9):644-50. doi: 10.1097/DBP.0b013e318235d614. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007376 |
| Interleukin-2 |
| D015847 | Interleukin-4 |
| D016209 | Interleukin-8 |
| D007371 | Interferon-gamma |
| D016232 | Endothelins |
| D015232 | Dinoprostone |
| D018799 | Intercellular Adhesion Molecule-1 |
| D019010 | Vascular Cell Adhesion Molecule-1 |
| D014409 | Tumor Necrosis Factor-alpha |
| D052242 | Adiponectin |
| D020738 | Leptin |
| D003545 | Cysteine |
| D006710 | Homocysteine |
| D009211 | Myoglobin |
| C545832 | Tnni3k protein, mouse |
| D003402 | Creatine Kinase |
| D052279 | Creatine Kinase, MB Form |
| D055442 | Metabolome |
| D005947 | Glucose |
| D002784 | Cholesterol |
| D014280 | Triglycerides |
| D014527 | Uric Acid |
| D003404 | Creatinine |
| D014508 | Urea |
| D012964 | Sodium |
| D011188 | Potassium |
| D001799 | Blood Sedimentation |
| C058176 | 5-nitro-2-(3-phenylpropylamino)benzoic acid |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D015065 | 17-Hydroxycorticosteroids |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000418 | Albumins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D007162 | Immunoproteins |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003165 | Complement System Proteins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
| D008222 | Lymphokines |
| D019743 | Chemokines, CXC |
| D018925 | Chemokines |
| D002630 | Chemotactic Factors |
| D018836 | Inflammation Mediators |
| D007372 | Interferons |
| D016215 | Macrophage-Activating Factors |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D015846 | Monokines |
| D048069 | Tumor Necrosis Factors |
| D054392 | Adipokines |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D009124 | Muscle Proteins |
| D003285 | Contractile Proteins |
| D005914 | Globins |
| D006420 | Hemeproteins |
| D017852 | Phosphotransferases (Nitrogenous Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D008660 | Metabolism |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D005989 | Glycerides |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D007093 | Imidazoles |
| D000577 | Amides |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |