NCT02858102

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2019

Enrollment Period

4.5 years

First QC Date

August 3, 2016

Last Update Submit

February 6, 2020

Conditions

Metabolic SyndromeMental Disorders

Keywords

SchizophreniaPsychosisObesityNeurocognitionDepressionBipolar disorderMetabolomicsBiomarkersHypertensionDyslipidemiaHyperglycemiaHypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in dyslipidemia measured by serum triglycerides and/or high-density lipoprotein (HDL cholesterol) levels.

    6 months

  • Change in hypertension measured by blood pressure

    6 months

  • Change in hyperglycemia measured by fasting plasma glucose

    6 months

  • Effect of physical activity intervention on serum biomarkers by using metabolomics

    6 months

Study Arms (2)

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.

Behavioral: Physical activity program

Control group

NO INTERVENTION

No physical activity program

Interventions

Physical activity programBEHAVIORAL

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.

Active treatment group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Dependence or severe alcohol consumers (\>300 g/week).
  • Co-infection with Hepatitis B, C or HIV.
  • Cirrhosis diagnosed or presence of other hepatic comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeMental DisordersSchizophreniaPsychotic DisordersObesityDepressionBipolar DisorderHypertensionDyslipidemiasHyperglycemiaHypertriglyceridemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersHyperlipidemias

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedicto Crespo-Facorro, Professor

CONTACT

+34 942202545benedicto.crespo@unican.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 8, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 7, 2020

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)