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NCT Number: NCT07113119

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

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.

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Key information

Conditions

Psychotic Disorder Behavior Mental Disorders Motor Activity Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline

    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).

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

    Time frame: 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).

  3. Handgrip Strength

    Time frame: Baseline

    Evaluation of the isometric handgrip strength using a hand dynamometer

  4. Handgrip Strength

    Time frame: Follow-up assessment, 12 months post- baseline

    Evaluation of the isometric handgrip strength using a hand dynamometer

  5. Sit-and-Reach Test

    Time frame: Baseline

    Evaluation of flexibility using sit- and- reach test

  6. Sit-and-Reach Test

    Time frame: Follow-up assessment, 12 months post- baseline

    Evaluation of flexibility using sit- and- reach test

  7. 30 -second Sit-to-stand test (STS)

    Time frame: Baseline

    Evaluation of functional capacity and mobility using 30-second STS

  8. 30 -second Sit-to-stand test (STS)

    Time frame: Follow-up assessment, 12 months post- baseline

    Evaluation of functional capacity and mobility using 30-second STS

  9. Six- Minute Walking Test

    Time frame: Baseline

    Estimation of aerobic capacity through six minute walking test

  10. Six- Minute Walking Test

    Time frame: Follow-up assessment, 12 months post- baseline

    Estimation of aerobic capacity through six minute walking test

  11. Berg Balance Scale Test

    Time frame: Baseline

    Evaluation of balance using Berg Balance Scale Test

  12. Berg Balance Scale Test

    Time frame: Follow-up assessment, 12 months post- baseline

    Evaluation of balance using Berg Balance Scale Test

  13. Short form Quality of Life (SF-36)

    Time frame: Baseline

    Assessment of Quality of Life using SF-36

  14. Short form Quality of Life (SF-36)

    Time frame: Follow-up assessment, 12 months post- baseline

    Assessment of Quality of Life using SF-36

Study contacts

Contact information is provided by the study sponsor or research team.

Evangelia Kouidi

CONTACT

[email protected]

+302310992189

Theochari Victoria

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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