Health Education Programme Through Physical Exercise for People With Severe Mental Disorders (HEPPE-PSMI)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Severe Mental Disorder; Obesity

Treatments: Behavioral: Standard physical activity; Behavioral: Guided physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06069739

Physical exercise programme

Details and patient eligibility

About

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 inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance, related to different physical exercise interventions?
• Do inflammatory, oxidative stress and cardiometabolic biomarkers predict neurocognitive improvement after physical activity training?

Participants will guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG).

If there is a comparison group: Researchers will compare GPAG and SPAG to see if inflammatory, oxidative stress, and cardio-metabolic biomarkers improve neurocognitive performance after physical activity training

Full 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 trial tested the efficacy of aerobic exercise as promoter of neurocognitive improvement across psychiatric disorders and OB comorbid. Participants (n=29) received brief healthy lifestyle counseling and were randomized to 12 weeks of guided-exercise of moderate intensity and frequency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG) (n=10) or 12 weeks of exercise standard physical activity without guided and incentives; standard physical activity group (SPAG) (n=19). Peripheral blood biomarkers of inflammation, oxidative stress, vascular mechanisms and metabolic activity, as well as neurocognitive and functional performance were assessed twice over after and before treatment. Mixed one-way analysis of variance and linear regression analyses were performed.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Guided physical activity group

Experimental group

Description:

Guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist.

Treatment:

Behavioral: Guided physical activity

Standard physical activity group

Active Comparator group

Description:

Standard physical activity without guided and incentives.

Treatment:

Behavioral: Standard physical activity