NCT07113119Recruiting
Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 4 Aug 2024
- Primary completion date
- 4 Aug 2025
- Lead sponsor
- Aristotle University Of Thessaloniki
- NCT number
- NCT07113119
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 4 Aug 2024 to the primary completion date, 4 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- not on stable medication
Other illness
- in an unstable condition
Other
- adolescents
- with other diagnoses
- unwilling to participate in the study
Who the study is looking for
- being an adult
- inpatient with a diagnosis of psychotic syndrome
- on stable medication
- controlled as far as psychosis is concerned
- consenting to participate
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sports Medicine Laboratory, Aristotle University of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.