Effects of exercise on health in patients with severe mental illness
Effectiveness of a Multicomponent Exercise Program on Health Status and Health-related Quality of Life in Patients With Severe Mental Illness: Study Protocol for a Randomized Controlled Trial.
This study is testing if a structured exercise program can help improve the physical health and well-being of people with severe mental illnesses living in Navarra.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidad Pública de Navarra Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 2 sites (Pamplona, Navarra and 1 other locations) |
| Trial ID | NCT05834309 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of physical exercise on the health status of individuals diagnosed with severe mental disorders. It aims to address the high mortality rates and comorbidities, particularly metabolic syndrome, prevalent in this population. Participants will be residents of Navarra and will engage in a structured exercise program, with their health outcomes monitored throughout the intervention. The study seeks to determine whether exercise can improve physical health and overall well-being in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are residents of Navarra diagnosed with severe mental disorders such as schizophrenia, bipolar disorder, or major depressive disorder, who also exhibit health maintenance issues.
Not a fit: Patients with severe mental disorders who are not residents of Navarra or do not meet the specific diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the physical health and quality of life for patients with severe mental illness.
How similar studies have performed: Other studies have shown promising results in using exercise as an intervention for improving health outcomes in patients with severe mental disorders, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pamplona, Navarra and 1 other locations
- Complejo Hospitalario de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Fundacion Miguel Servet — Pamplona, Navarra, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Urteaga — Complejo Hospitalario de Navarra
- Study coordinator: Mikel Lopez Saez de Asteasu, PhD
- Email: mikel.lopez.saezdeasteasu@gmail.com
- Phone: +34 848 423199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.