Status:
COMPLETED
Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Severe Mental Disorder
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to \[learn about, test, compare etc.\] in individuals with severe mental disorders and obesity comorbid. The main question\[s\] it aims to answer are: * Are inflam...
Detailed Description
The psychiatric disorders and obesity comorbidity is related to neurocognitive impairment and inflammation. Exercise is crucial to improve and maintain healthy lifestyles. This randomized controlled t...
Eligibility Criteria
Inclusion
- MDD, BD and SZ were diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM-5 (APA, 2014).
- Participants with MDD and BD should meet the remission criteria (Tohen et al., 2009) of an acute affective episode, defined as Young Mania Rating Scale (YMRS) score ≤ 6 and Hamilton Rating Scale for Depression (HRSD) score ≤ 8, and individuals with SZ had to be clinically stable, defined as Positive and Negative Syndrome Scale (PANSS) score ≤ 36.
- The comorbid OB diagnosis was based on World Health Organization (WHO) criteria.
- Ability to understand study procedures and willingness to give written consent was required for participation.
- For recruitment as HC
- Absence of physical illness
- Absence of pharmacological treatments
- Absence of family history of psychiatric disorders in first-degree relatives were required.
- Ability to understand study procedures and willingness to give written consent was required for participation.
Exclusion
- current hospitalization
- documented cognitive impairment not secondary to psychiatric disorder (intellectual disability or major neurocognitive disorder, i.e. dementia)
- disability or inability that prevented understanding of the protocol
- current substance use disorders (except for nicotine)
- pregnancy
- intake of steroids
- corticosteroids, antioxidants, antibiotics, and immunologic therapies
- fever over 38°C
- history of vaccination within 4 weeks of the evaluation
- medical contraindications for exercise
- body mass index ≥ 40
- diastolic/systolic blood pressure ≥ 140/90
- resting heart rate ≥ 100.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06069739
Start Date
March 1 2016
End Date
June 30 2016
Last Update
October 6 2023
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