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Impact of Aerobic Exercise on Metabolic Syndrome, Neurocognition and Empowerment in Individuals With Mental Disorders (EXERTMG)

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ClinicalTrials.gov Identifier: NCT02858102
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Information provided by (Responsible Party):
Benedicto Crespo-Facorro, Fundación Marques de Valdecilla

Brief Summary:
This study aims to develop a program of systematic physical exercise maintained for at least 12 weeks to normalize biomarkers of metabolic syndrome; improve neurocognition and social functioning; increase empowerment, self-esteem and self-efficacy and reduce self-stigma in individuals with severe mental disorder with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Mental Disorders Behavioral: Physical activity program Not Applicable

Detailed Description:

Major depressive disorder has an estimated annual prevalence of 4% in Spain and the risk of a major depressive episode is 10.6%. Although there are few studies available, there is growing evidence regarding the fact that patients with affective disorders have a higher morbidity and mortality in relation to general population. This mortality would be duplicated mainly due to suicides but also by other factors such as increased metabolic risk and cardiovascular diseases. In Europe, depression is one of the leading causes of lost productivity, early retirement and absence from work due to illness and it will be the first cause of disease burden worldwide in 2030 according to World Health Organization. Several reasons could explain it: from the adverse effects of medication, less access to health services, until unhealthy lifestyle options associated with a loss of quality of life related to health.

Bipolar disorder is a serious mental illness that can affect between 2 and 5% of the population. This disease has a major impact on patient functioning and it is in sixth place among all diseases as a global cause of disability. Depending on the studies, metabolic syndrome is present between 8 and 56% of patients with bipolar disorder what this leads to increased morbidity and mortality affecting of their quality of life.

Annual incidence rates of psychosis are from 0.2 to 0.4 per 1000 population and prevalence throughout life is about 1%, being similar between men and women although the start in women is later. The age of onset is between 15 and 30 years and it has a significant economic impact on patient, on his family and society in general. Schizophrenia is a psychotic disorder in which the person suffers from delusions or hallucinations with a disorganized thought or speech and negative symptoms that are not accompanied by insight. Historically it has been associated with greater vulnerability and higher rates of physical comorbidity and excess mortality. In physical comorbidity highlights cardiovascular diseases and they are attributed a 60% mortality together with metabolic syndrome, which is 2-3 times more frequent than in the general population. This increase in morbidity and mortality is related to a style of unhealthy life (bad eating habits and lack of exercise), use of antipsychotic drugs and disease as intrinsic factor.

There has been an increase in interest for the study of metabolic syndrome (MetS) in psychiatric patients in recent decades. Although his description has evolved over time, we can define the MetS as a group of risk factors (abdominal obesity, elevated blood pressure, elevated fasting plasma glucose, high serum triglycerides and low high-density lipoprotein (HDL cholesterol) levels) that predict the onset of coronary heart disease, type 2 diabetes, gallstones, asthma, sleep apnea, fatty liver disease and several cancers. The most commonly used criteria for his diagnosis are the National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III 2003), requires at least three of the following risk factors:

  1. Elevated waist circumference: ≥102 cm in men and ≥88 cm in women.
  2. Elevated serum triglycerides: ≥150 mg/dL or drug treatment.
  3. Reduced HDL cholesterol: <40 mg/dL in men and <50 mg/dL in women or drug treatment.
  4. Elevated blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or drug treatment.
  5. Elevated fasting glucose: ≥100 mg/dL or drug treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact From Aerobic Exercise (a Program of Physical Activity) in the Metabolic Syndrome, Neurocognition and Empowerment in Individuals With Severe Mental Disorders Including Depression, Bipolar Disorder and Psychosis: a Longitudinal Study
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Active treatment group
Physical activity program: 36 sessions of physical activity lasting between 30-60 minutes for 12 weeks, three days per week.
Behavioral: Physical activity program
The intensity of physical activity will be adapted to the possibilities of the participants making individualized proposals to encourage participants to acquire active lifestyle habits to improve their health. All sessions end with a routine of relaxation and passive stretching. Simultaneously self-employment is controlled outside the guided sessions.

No Intervention: Control group
No physical activity program



Primary Outcome Measures :
  1. Change in abdominal obesity measured by waist circumference [ Time Frame: 6 months ]

    Abdominal obesity, also known as central obesity, is when excessive abdominal fat around the stomach and abdomen has built up to the extent that it is likely to have a negative impact on health.

    Men are considered to be at high risk from abdominal obesity if their waist measurements are 102 cm or higher, while women are considered to be at high risk if their waist measurements are 88 cm or higher.



Secondary Outcome Measures :
  1. Change in dyslipidemia measured by serum triglycerides and/or high-density lipoprotein (HDL cholesterol) levels. [ Time Frame: 6 months ]

    Dyslipidemia is an abnormal amount of lipids (e.g.,triglycerides, cholesterol and/or fat phospholipids) in the blood.

    The normal triglyceride level is between 30 and 150 mg/dL. The normal HDL cholesterol level is between 40 and 60 mg/dL.


  2. Change in hypertension measured by blood pressure [ Time Frame: 6 months ]

    Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long term medical condition in which the blood pressure in the arteries is persistently elevated.

    Blood pressure is expressed by two measurements, the systolic and diastolic pressures, which are the maximum and minimum pressures, respectively. Normal blood pressure at rest is within the range of 100-130 millimeters mercury (mmHg) systolic and 60-85 mmHg diastolic.


  3. Change in hyperglycemia measured by fasting plasma glucose [ Time Frame: 6 months ]

    Hyperglycemia, or high blood sugar (also spelled hyperglycaemia) is a condition in which an excessive amount of glucose circulates in the blood plasma.

    A subject with a consistent range between 100-126 mg/dl is considered hyperglycemic, while above 126 mg/dl is generally held to have diabetes.


  4. Effect of physical activity intervention on serum biomarkers by using metabolomics [ Time Frame: 6 months ]

    Metabolomics can be defined as the quantitative and qualitative analysis of all metabolites (molecules with a molecular weight of less than 1,500 Da) in a given organism, resulting in the construction of a metabolome or metabolic fingerprint, analogous to the genome or the proteome. Metabolomics is based on high-resolution mass spectrometry coupled to ultra-performance liquid chromatography.

    The following biomarkers will be screened: Cytokines; Irisin, adiponutrin, adiponectin, resistin, leptin; Pro-inflammation status: tumor necrosis factor (TNF-a); Interleukin (IL-1b, IL-6), alpha-1-antitrypsin, serum amyloid A, fibrinogen, C reactive protein; Oxidative stress: LDL-oxidized and anti-LDL-oxidized antibodies.




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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression, bipolar disorder or psychosis (at least 5 years of diagnosis).
  • Meet criteria for metabolic syndrome (NCEP-ATP III 2003).
  • Capable of providing signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation.
  • Women of child-bearing potential must be ready and able to use highly effective methods of birth control.

Exclusion Criteria:

  • Dependence or severe alcohol consumers (>300 g/week).
  • Co-infection with Hepatitis B, C or HIV.
  • Cirrhosis diagnosed or presence of other hepatic comorbidities.
  • Patients participating in a physical intervention program at least 6 months before inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858102


Contacts
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Contact: Benedicto Crespo-Facorro, Professor +34 942202545 benedicto.crespo@unican.es

Locations
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Spain
University Hospital Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Fundación Marques de Valdecilla
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Investigators
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Principal Investigator: Benedicto Crespo-Facorro, Professor University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain

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Responsible Party: Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla
ClinicalTrials.gov Identifier: NCT02858102     History of Changes
Other Study ID Numbers: EXERTMG
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benedicto Crespo-Facorro, Fundación Marques de Valdecilla:
Schizophrenia
Psychosis
Obesity
Neurocognition
Depression
Bipolar disorder
Metabolomics
Biomarkers
Hypertension
Dyslipidemia
Hyperglycemia
Hypertriglyceridemia
Additional relevant MeSH terms:
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Metabolic Syndrome
Disease
Syndrome
Mental Disorders
Psychotic Disorders
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Schizophrenia Spectrum and Other Psychotic Disorders