RecruitingNot ApplicableNCT07113119

Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders


Sponsor

Aristotle University Of Thessaloniki

Enrollment

48 participants

Start Date

Aug 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a long-term structured exercise program can improve physical fitness and brain health in adults hospitalized with psychosis. People with psychotic disorders are often physically inactive and at higher risk for metabolic health problems. The study aims to show that regular exercise is feasible and beneficial in this population. **You may be eligible if...** - You are an adult (18 or older) - You are an inpatient with a diagnosis of a psychotic syndrome - You are on a stable medication regimen - Your psychosis is currently controlled (stable phase) - You are willing to participate **You may NOT be eligible if...** - You are an adolescent (under 18) - You have a different primary diagnosis - You are not on stable medication - Your psychosis is currently unstable - You are unwilling to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise intervention

Patients that will be randomly assigned in the group A will be invited to attent 1-year exercise sessions, with frequency 3 sessions per week. The program included 30 minutes of Pilates exercises, strengthening, balance and flexibility exercises, which are performed with rubber bands, mobility sticks and balls.


Locations(1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece

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NCT07113119


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