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Search / Trial NCT05834309

Exercise Effects on Health Status in Patients With Severe Mental Illness

Launched by UNIVERSIDAD PÚBLICA DE NAVARRA · Apr 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring how exercise can improve health for people with severe mental illnesses, such as schizophrenia and bipolar disorder. Research shows that individuals with these conditions often face higher health risks, particularly related to heart disease and metabolic issues. The study aims to determine how a structured exercise program, combined with regular mental health care, can enhance physical fitness, mental well-being, and overall quality of life.

To participate, individuals aged 18 to 65 who live in Navarra and have a diagnosed severe mental disorder may be eligible, especially if they also face challenges like poor nutrition or lack of physical activity. Participants will be divided into two groups: one will receive standard care, while the other will join a 6-week exercise program that meets twice a week. Throughout the study, the researchers will evaluate various health aspects, including physical strength, mood, and lifestyle habits. This trial is an important step in understanding how exercise can be a beneficial part of treatment for those facing severe mental health challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • resident in Navarra
  • diagnosis of severe mental disorder (DSM 5: Schizophrenia 295.90, Tr. Schizoaffective Disorder 295.70, Schizotypal Personality Disorder 301.22, Schizoid Personality Disorder 301.20, Schizophreniform Personality Disorder 295.40, Psychotic Disorder with Delusional Ideas 295.40, Psychotic Disorder with Delusional Ideas 295.40. Schizophreniform 295.40, Psychotic disorder with delusions 293.81, Psychotic disorder with hallucinations 293.82, Major depressive disorder 296.33, Bipolar disorder type I 296.44, Bipolar disorder type II 296.89, Obsessive Compulsive Disorder 300.
  • primary nursing diagnosis NANDA and Virginia Henderson NOC 0099 Ineffective Health Maintenance
  • at least one of the secondary nursing diagnoses 001 Nutritional Imbalance due to Excess, 003 Risk of Nutritional Imbalance due to Excess, 00096 Sleep Deprivation, 00146 Anxiety or 00168 Sedentary
  • willing to voluntarily participate in the randomly assigned intervention, after signing the informed consent form.
  • Exclusion Criteria:
  • acute illness that does not allow physical exercise sessions or assessments during the study
  • medical contraindication that prevents physical exercise
  • treatment with Interleukin-6 receptor antagonists (tocilizumab) during the last month due to drug interference with adaptations to cardiopulmonary exercise
  • refusal to sign the informed consent form by the study subject
  • impossibility of follow-up.

About Universidad Pública De Navarra

The Universidad Pública de Navarra (UPNA) is a prestigious public institution committed to advancing research and education in various fields, including health sciences. As a clinical trial sponsor, UPNA leverages its academic expertise and state-of-the-art facilities to facilitate innovative research initiatives aimed at improving patient outcomes and enhancing medical knowledge. The university fosters collaboration among multidisciplinary teams, ensuring rigorous adherence to ethical standards and regulatory requirements while promoting scientific excellence. Through its clinical trials, UPNA contributes significantly to the advancement of healthcare practices and the development of new therapeutic interventions.

Locations

Pamplona, Navarra, Spain

Pamplona, Navarra, Spain

Patients applied

0 patients applied

Trial Officials

Ana Urteaga

Principal Investigator

Complejo Hospitalario de Navarra

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported