Clinical trial NCT06069739: Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
Official title: Development and Evaluation of a Health Education Programme Through Physical Exercise for the Development of Autonomous Physical Activity Habits in People With Severe Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Mental Disorder
Obesity
Keywords: Exercise
Neurocognition
Inflammation
Oxidative stress
Vascular damage
Metabolic activity
Mental illnesses
Obesity
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants were randomly assigned in a 1:1 ratio to a 12-week program of either; (a) 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). Both groups followed the same randomized recruitment procedure, data collection and follow-up. All treatment sessions were conducted from March to June 2016. To maintain the rigor of the research, possible risks that could question the internal and external validity of the study results were identified and strategies were proposed to eliminate them.
Primary purpose: TREATMENT

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 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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Verbal learning and memory
timeFrame: 4 months
measure: Cognitive flexibility
timeFrame: 4 months
measure: Verbal fluency
timeFrame: 4 months
measure: Working memory
timeFrame: 4 months
measure: Short-term memory
timeFrame: 4 months
measure: Visual memory
timeFrame: 4 months
measure: Processing speed
timeFrame: 4 months
measure: Functional Assessment Short Test
timeFrame: 4 months
measure: Short Form-36 Health Survey questionnaire
timeFrame: 4 months
measure: World Health Organization Quality of Life brief scale
timeFrame: 4 months
measure: Inflammatory markers
timeFrame: 4 months
measure: Oxidative stress markers
timeFrame: 4 months
measure: Adhesion molecules markers
timeFrame: 4 months
measure: Metabolic markers
timeFrame: 4 months
measure: Maximum heart rate
timeFrame: 4 months
measure: Systolic pressure/diastolic pressure
timeFrame: 4 months
measure: Waist circumference
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Rafael Tabarés-Seisdedos
role: PRINCIPAL_INVESTIGATOR
References: