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

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

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.

Study Overview

• Status: Unknown
• Conditions: Mental Disorders; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Physical activity program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • University Hospital Marqués de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in abdominal obesity measured by waist circumference	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dyslipidemia measured by serum triglycerides and/or high-density lipoprotein (HDL cholesterol) levels.	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.	6 months
Change in hypertension measured by blood pressure	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.	6 months
Change in hyperglycemia measured by fasting plasma glucose	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.	6 months
Effect of physical activity intervention on serum biomarkers by using metabolomics	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.	6 months

Collaborators and Investigators

• Sponsor: Fundación Marques de Valdecilla
• Collaborators: Centro de Investigación Biomédica en Red de Salud Mental; Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Schizophrenia; Psychosis; Obesity; Dyslipidemia; Hypertension; Metabolomics; Hyperglycemia; Biomarkers; Bipolar disorder; Neurocognition; Hypertriglyceridemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Disease; Psychotic Disorders; Metabolic Syndrome; Mental Disorders
• Other Study ID Numbers: EXERTMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No