NCT06069739

Health Education Programme Through Physical Exercise for People With Severe Mental Disorders

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Severe Mental Disorder
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Guided physical activity	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.
BEHAVIORAL	Standard physical activity	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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2023-10-06
• Last updated: 2023-10-06