NCT07113119 Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
| NCT ID | NCT07113119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Psychotic Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-08-04 |
| Primary Completion | 2025-08-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-08-04 with a primary completion date of 2025-08-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mental health represents a fundamental dimension of overall well-being, exerting a significant influence on mortality rates, health-related quality of life (HRQoL), levels of disability, and the strain on healthcare systems. As the interest in mental wellness continues to grow, exercise training (ET) has become increasingly recognized as a validated and effective intervention for individuals experiencing mental health challenges. An expanding body of research underscores the adverse effects of physical inactivity, reinforcing the role of exercise as a viable therapeutic strategy. Well-structured ET interventions have consistently demonstrated benefits across multiple domains, including improvements in physical health, reductions in cardiovascular risk, and enhancements in psychological constructs such as depression, self-esteem, resilience, and self-efficacy. However, the majority of prior studies have been limited to relatively short durations-typically ranging from 4 to 24 weeks, with an average of about 12 weeks. A significant gap in the literature persists regarding the long-term implementation and effectiveness of ET programs, particularly in populations with severe mental illness. Additionally, the small sample sizes commonly seen in previous studies restrict the statistical robustness and generalizability of their outcomes. The aim of the randomized control trial is to examine whether an 1-year mixed type exercise training program within the hospital setting will improve functional capacity and health-related quality of life. Forty- eight participants will be randomly allocated into two groups: Group A (Exercise group) will receive 3 exercise sessions per week for 1-year and Group B (Control Group) will continue their usual care, without participating in organized exercise programs. Prior to the group random allocation, part of the assessment at the baseline and 1 year follow-up will include lower extremity strength test, muscle power using a dynamometer, aerobic capacity test, balance test, body positioning and health- related quality of life.
Eligibility Criteria
Inclusion Criteria: * being an adult * inpatient with a diagnosis of psychotic syndrome * on stable medication * controlled as far as psychosis is concerned * consenting to participate Exclusion Criteria: * adolescents * with other diagnoses * not on stable medication * in an unstable condition * unwilling to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07113119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psychotic Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07113119 currently recruiting?
Yes, NCT07113119 is actively recruiting participants. Contact the research team at kouidi@phed.auth.gr for enrollment information.
Where is the NCT07113119 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT07113119 clinical trial?
NCT07113119 is sponsored by Aristotle University Of Thessaloniki. The trial plans to enroll 48 participants.