Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise intervention.
- Who it may be relevant to
- Registry conditions: Psychotic Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Exercise 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.
Primary outcome measures
- Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer [Time frame: Baseline]
- Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer [Time frame: Follow-up assessment, 12 months post- baseline]
- Handgrip Strength [Time frame: Baseline]
- Handgrip Strength [Time frame: Follow-up assessment, 12 months post- baseline]
- Sit-and-Reach Test [Time frame: Baseline]
- Sit-and-Reach Test [Time frame: Follow-up assessment, 12 months post- baseline]
- 30 -second Sit-to-stand test (STS) [Time frame: Baseline]
- 30 -second Sit-to-stand test (STS) [Time frame: Follow-up assessment, 12 months post- baseline]
- Six- Minute Walking Test [Time frame: Baseline]
- Six- Minute Walking Test [Time frame: Follow-up assessment, 12 months post- baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- Sports Medicine Laboratory, Aristotle University of Thessaloniki — Thessaloniki
Identifiers
NCT: NCT07113119 · EH-44/2021