Clinical trial NCT02858102: Impact of Aerobic Exercise on Metabolic Syndrome, Neurocognition and Empowerment in Individuals With Mental Disorders
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Mental Disorders
Keywords: Schizophrenia
Psychosis
Obesity
Neurocognition
Depression
Bipolar disorder
Metabolomics
Biomarkers
Hypertension
Dyslipidemia
Hyperglycemia
Hypertriglyceridemia
Lead sponsor: Fundación Marques de Valdecilla
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Salud Mental
name: Instituto de Investigación Marqués de Valdecilla
First posted: 2016-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in abdominal obesity measured by waist circumference
timeFrame: 6 months
Secondary outcomes:
measure: Change in dyslipidemia measured by serum triglycerides and/or high-density lipoprotein (HDL cholesterol) levels.
timeFrame: 6 months
measure: Change in hypertension measured by blood pressure
timeFrame: 6 months
measure: Change in hyperglycemia measured by fasting plasma glucose
timeFrame: 6 months
measure: Effect of physical activity intervention on serum biomarkers by using metabolomics
timeFrame: 6 months
Other outcomes:
Locations:
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
state: Cantabria
Study officials:
affiliation: 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
name: Benedicto Crespo-Facorro, Professor
role: PRINCIPAL_INVESTIGATOR
References: