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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07113119
Enrollment
48
Registered
2025-08-08
Start date
2024-08-04
Completion date
2025-08-15
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorder

Keywords

Exercise, Functional ability, Quality of life, Pilates

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.

Interventions

OTHERExercise 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.

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg DynamometerBaselineThe 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).
Handgrip StrengthBaselineEvaluation of the isometric handgrip strength using a hand dynamometer
Sit-and-Reach TestBaselineEvaluation of flexibility using sit- and- reach test
30 -second Sit-to-stand test (STS)BaselineEvaluation of functional capacity and mobility using 30-second STS
Six- Minute Walking TestBaselineEstimation of aerobic capacity through six minute walking test
Berg Balance Scale TestBaselineEvaluation of balance using Berg Balance Scale Test
Short form Quality of Life (SF-36)BaselineAssessment of Quality of Life using SF-36

Countries

Greece

Contacts

Primary ContactEvangelia Kouidi
kouidi@phed.auth.gr+302310992189
Backup ContactTheochari Victoria
victoriatheohari@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026