Metabolic SyndromeEXERTMGNCT02858102
Impact of Aerobic Exercise on Metabolic Syndrome, Neurocognition and Empowerment in Individuals With Mental Disorders
A study testing Physical activity program in people with Metabolic Syndrome and Mental Disorders, run by Fundación Marques de Valdecilla at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Metabolic Syndrome, Mental Disorders
- What is being tested?
- Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
About this study
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
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.
Read the 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:
- Elevated waist circumference: ≥102 cm in men and ≥88 cm in women.
- Elevated serum triglycerides: ≥150 mg/dL or drug treatment.
- Reduced HDL cholesterol: <40 mg/dL in men and <50 mg/dL in women or drug treatment.
- Elevated blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or drug treatment.
- Elevated fasting glucose: ≥100 mg/dL or drug treatment.
- Conditions
- Metabolic Syndrome, Mental Disorders
- Being tested
- Physical activity program
- Keywords
- Schizophrenia, Psychosis, Obesity, Neurocognition, Depression, Bipolar disorder, Metabolomics, Biomarkers, Hypertension, Dyslipidemia, Hyperglycemia, Hypertriglyceridemia
- Medical subject headings
- Metabolic Syndrome, Mental Disorders, Schizophrenia, Psychotic Disorders, Obesity, Depression, Bipolar Disorder, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group | Active comparator | Physical activity program: 36 sessions of physical activity lasting between 30-60 minutes for 12 weeks, three days per week. Receives: Behavioral: Physical activity program |
| Control group | No intervention | No physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Marques de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Responsible party
- Principal investigator, Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
- Investigators
- Benedicto Crespo-Facorro, Professor, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858102
- Sponsor's protocol ID
- EXERTMG
- Acronym
- EXERTMG
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2016
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858102
- Acronym / sponsor ID
- EXERTMG / EXERTMG
- Conditions
- Metabolic Syndrome, Mental Disorders
- Keywords
- Schizophrenia, Psychosis, Obesity, Neurocognition, Depression, Bipolar disorder, Metabolomics, Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundación Marques de ValdecillaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Elevated waist circumference: ≥102 cm in men and ≥88 cm in women.
- Elevated serum triglycerides: ≥150 mg/dL or drug treatment.
- Reduced HDL cholesterol: <40 mg/dL in men and <50 mg/dL in women or drug treatment.
- Elevated blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or drug treatment.
- Elevated fasting glucose: ≥100 mg/dL or drug treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment group | Active comparator | Behavioral: Physical activity programPhysical activity program: 36 sessions of physical activity lasting between 30-60 minutes for 12 weeks, three days per week. |
| Control group | No intervention | –No physical activity program |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programThe 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. | Behavioural | Active treatment group |
Primary outcome
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.
4 secondary outcomes
Change in dyslipidemia measured by serum triglycerides and/or high-density lipoprotein (HDL cholesterol) levels.
Time frame: 6 months
Change in hypertension measured by blood pressure
Time frame: 6 months
Change in hyperglycemia measured by fasting plasma glucose
Time frame: 6 months
Effect of physical activity intervention on serum biomarkers by using metabolomics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedicto Crespo-Facorro, Professor principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Metabolic Syndrome and Mental Disorders, run by Fundación Marques de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedicto Crespo-Facorro, Professor (+34 942202545, benedicto.crespo@unican.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal obesity measured by waist circumference (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.