Mother-caregivers of Children With Duchenne Muscular Dystrophy

Not Applicable

Completed

• Conditions: Other Diseases or Conditions
• Interventions: Biological: Inflammatory profile; Biological: Hormonal profile; Biological: sleep parameters; Biological: Metabolic profile; Biological: Cardiovascular profile

• Registration Number: NCT01921374
• Lead Sponsor: Monica Levy Andersen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-13
• Study Completion: 2014-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
imflammatory and immunological profile	Inflammatory profile	To assess the inflammatory profile of caregivers-mothers and control mothers
hormonal profile	Hormonal profile	To assess the hormonal profile of caregivers-mothers and control mothers.
sleep parameters	sleep parameters	To assess the sleep parameters.
metabolic profile	Metabolic profile	To assess the health profile of caregivers-mothers and control mothers.
cardiovascular parameters	Cardiovascular profile	To assess the cardiovascular profile of control mothers and caregivers-mothers.

Primary Outcome Measures

Name	Time	Method
sleep patterns of the study population	Baseline	Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular profile	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)
Hormonal profile	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)
Metabolic profile	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
Inflammatory profile	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)

Trial Locations

Locations (1)

University Federal of São Paulo; 🇧🇷 São Paulo, Brazil