NCT07113119

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

Recruiting now NA Last updated 8 August 2025

What this trial tests

NA trial testing Exercise intervention in Psychotic Disorder in 48 participants. Currently enrolling.

Timeline

4 August 2024

Primary endpoint
4 August 2025

15 August 2025

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	4 August 2024
Primary completion	4 August 2025
Estimated completion	15 August 2025
Sites	1 location across Greece

Drugs / interventions tested

• Exercise intervention

Conditions studied

• Psychotic Disorder — all drugs for Psychotic Disorder →

Sponsor

Aristotle University Of Thessaloniki

Who can join

18 and older, any sex, with Psychotic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of a Long-Term Exercise Training Program on the Functional Capacity and Health-Related Quality of Life in Inpatients with Psychotic Disorders: A Randomized Controlled Trial.
   Theochari V, Mameletzi D, Teloudi A, Kaprinis S, et al · · 2025 · PMID 41133591 · DOI 10.3390/jfmk10040401