Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
Condition: Severe Mental Disorder; Obesity
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

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.
    

Intervention name(s): Guided physical activity; Standard physical activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): To achieve the European guidelines of 150 minutes by week of moderate intensity physical activity, participants randomized to the GPAG condition were prescribed three 60 minutes exercise sessions (five minutes of warm-up and five minutes of cool-down for a total of sixty minutes per session) per week for 12 weeks. Exercise consisted of brisk walking in urban and rural open spaces during which heart rate monitors were worn and participants were instructed to stay within their moderate intensity range. The incentives were different proposals for specific exercises to train the different musculoskeletal areas more comprehensively. Autonomous exercise was monitored offside the sessions through a series of weekly checkpoints.; Participants randomised to the SPAG performed their usual daily activities and continued with their daily routine.
Both conditions were matched for duration of physical activity. Participants in both conditions were required to attend three on-site sessions by week over 12 weeks that served as checkpoints. Moreover, both conditions were provided with brief healthy lifestyle counseling at baseline.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise; Neurocognition; Inflammation; Oxidative stress; Vascular damage; Metabolic activity; Mental illnesses; Obesity