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Mother-caregivers of Children With Duchenne Muscular Dystrophy (DMDK)

2. februar 2016 opdateret af: Monica Levy Andersen

Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • São Paulo, Brasilien, 04024001
        • University Federal of Sao Paulo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Mothers-caregivers of children and adolescents with DMD
  • Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome)

Exclusion Criteria:

  • Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
  • Working mothers of nocturnal period

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: sleep parameters
To assess the sleep parameters.
Biologisk: sleep parameters
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
Andet: cardiovascular parameters
To assess the cardiovascular profile of control mothers and caregivers-mothers.
Biologisk: 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
Andre navne:
  • Homocysteine
  • Myoglobin
  • Cardiac troponin I
  • Creatine kinase (CK)
  • Creatine kinase MB (CKMB)
Eksperimentel: imflammatory and immunological profile
To assess the inflammatory profile of caregivers-mothers and control mothers
Biologisk: 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
Andre navne:
  • Leptin
  • Prostaglandin E2
  • Cystein
  • Interleukin 2
  • C-reactive protein (PCR)
  • Immunoglobulin A (IgA)
  • Immunoglobulin G (IgG)
  • Immunoglobulin M (IgM)
  • Complement (C3)
  • Complement (C4)
  • Interleukin 6
  • Interleukin 10
  • Interleukin 1β
  • Interleukin 4
  • Interleukin 8
  • Interferon-gamma (IFN-γ)
  • Endothelin
  • Intercellular Adhesion Molecule 1 (ICAM)
  • Vascular cell adhesion protein 1 (VCAM)
  • Tumor necrosis factor (TNFα)
  • Adiponectin
  • Lymphocytes subpopulations (T e B)
Eksperimentel: hormonal profile
To assess the hormonal profile of caregivers-mothers and control mothers.
Biologisk: 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.
Andre navne:
  • Kortisol
  • Progesteron
  • Østradiol
  • Insulin
  • Vitamin B12
  • Luteinizing hormone (LH)
  • Follicle-stimulating hormone (FSH)
  • Total Testosterone
  • Adrenocorticotropic hormone (ACTH)
Eksperimentel: metabolic profile
To assess the health profile of caregivers-mothers and control mothers.
Biologisk: 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
Andre navne:
  • Glukose
  • Kreatinin
  • Urinstof
  • Total cholesterol and fractions
  • Triglycerides
  • Uric acid
  • Sodium
  • Potassium
  • Hemogram
  • Erythrocyte sedimentation rate
  • Natriuretic Peptide B

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
sleep patterns of the study population
Tidsramme: Baseline
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hormonal profile
Tidsramme: Baseline

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
Inflammatory profile
Tidsramme: Baseline

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
Tidsramme: Baseline

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
Tidsramme: Baseline

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Monica Levy Andersen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

8. august 2013

Først indsendt, der opfyldte QC-kriterier

9. august 2013

Først opslået (Skøn)

13. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DMDK

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner