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

NCT06069739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-10-06

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Principal Investigators

  • Rafael Tabarés-Seisdedos · Consorcio Centro de Investigación Biomédica en Red (CIBER)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2016-06-30
Completion
2016-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069739 on ClinicalTrials.gov