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

Not Applicable

Recruiting

• Conditions: Psychotic Disorder

• Registration Number: NCT07113119
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-04
• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Primary Completion: 2025-08-04
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30 -second Sit-to-stand test (STS)	Follow-up assessment, 12 months post- baseline	Evaluation of functional capacity and mobility using 30-second STS
Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer	Follow-up assessment, 12 months post- baseline	The isometric strength of the lower extremities is evaluated in a semi-squat position using a Baseline Leg Dynamometer, with muscular strength quantified in kilograms (kg).
Handgrip Strength	Follow-up assessment, 12 months post- baseline	Evaluation of the isometric handgrip strength using a hand dynamometer
Six- Minute Walking Test	Follow-up assessment, 12 months post- baseline	Estimation of aerobic capacity through six minute walking test
Short form Quality of Life (SF-36)	Follow-up assessment, 12 months post- baseline	Assessment of Quality of Life using SF-36
Sit-and-Reach Test	Follow-up assessment, 12 months post- baseline	Evaluation of flexibility using sit- and- reach test
Berg Balance Scale Test	Follow-up assessment, 12 months post- baseline	Evaluation of balance using Berg Balance Scale Test

Trial Locations

Locations (1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki; 🇬🇷 Thessaloníki, Thermi, Greece