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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAristotle University Of Thessaloniki

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

being an adult

inpatient with a diagnosis of psychotic syndrome

on stable medication

controlled as far as psychosis is concerned

Disqualifiers

adolescents

with other diagnoses

not on stable medication

in an unstable condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise intervention

    Other 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: GROUP A: EXERCISE GROUPExperimental treatment 1 intervention
Group B: GROUP B: CONTROL GROUPNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline
2

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).

Time frame
Follow-up assessment, 12 months post- baseline
3

Handgrip Strength

Evaluation of the isometric handgrip strength using a hand dynamometer

Time frame
Baseline
4

Handgrip Strength

Evaluation of the isometric handgrip strength using a hand dynamometer

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

Secondary outcomes

Other outcomes

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