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

NCT07113119 | Recruiting

• 1 other identifier: EH-44/2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorder

Keywords

Exercise; Functional ability; Quality of life; Pilates

Outcome Measures

Primary Outcomes (14)

• Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer

  The isometric strength of the lower extremities is evaluated in a semi-squat position using a Baseline Leg Dynamometer, with musclular strength quantified in kilograms (kg).

  Baseline

• Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer

  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).

  Follow-up assessment, 12 months post- baseline

• Handgrip Strength

  Evaluation of the isometric handgrip strength using a hand dynamometer

  Baseline

• Handgrip Strength

  Evaluation of the isometric handgrip strength using a hand dynamometer

  Follow-up assessment, 12 months post- baseline

• Sit-and-Reach Test

  Evaluation of flexibility using sit- and- reach test

  Baseline

• Sit-and-Reach Test

  Evaluation of flexibility using sit- and- reach test

  Follow-up assessment, 12 months post- baseline

• 30 -second Sit-to-stand test (STS)

  Evaluation of functional capacity and mobility using 30-second STS

  Baseline

• 30 -second Sit-to-stand test (STS)

  Evaluation of functional capacity and mobility using 30-second STS

  Follow-up assessment, 12 months post- baseline

• Six- Minute Walking Test

  Estimation of aerobic capacity through six minute walking test

  Baseline

• Six- Minute Walking Test

  Estimation of aerobic capacity through six minute walking test

  Follow-up assessment, 12 months post- baseline

• Berg Balance Scale Test

  Evaluation of balance using Berg Balance Scale Test

  Baseline

• Berg Balance Scale Test

  Evaluation of balance using Berg Balance Scale Test

  Follow-up assessment, 12 months post- baseline

• Short form Quality of Life (SF-36)

  Assessment of Quality of Life using SF-36

  Baseline

• Short form Quality of Life (SF-36)

  Assessment of Quality of Life using SF-36

  Follow-up assessment, 12 months post- baseline

Study Arms (2)

GROUP A: EXERCISE GROUP

EXPERIMENTAL

Exercise group: 1-year mixed-type exercise training program

Other: Exercise intervention

GROUP B: CONTROL GROUP

NO INTERVENTION

Control Group: 1-year normal physical activity, without participating in organized sports programs

Interventions

Exercise intervention OTHER

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.

GROUP A: EXERCISE GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being an adult
• inpatient with a diagnosis of psychotic syndrome
• on stable medication
• controlled as far as psychosis is concerned
• consenting to participate

You may not qualify if:

• adolescents
• with other diagnoses
• not on stable medication
• in an unstable condition
• unwilling to participate in the study

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, Thermi, Greece

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Central Study Contacts

Evangelia Kouidi

CONTACT

+302310992189; kouidi@phed.auth.gr

Theochari Victoria

CONTACT

victoriatheohari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Sports Medicine

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 8, 2025
• Study Start: August 4, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 15, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

GR (1)