Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
NCT ID: NCT07113119
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2024-08-04
2025-08-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GROUP A: EXERCISE GROUP
Exercise group: 1-year mixed-type exercise training program
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.
GROUP B: CONTROL GROUP
Control Group: 1-year normal physical activity, without participating in organized sports programs
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* inpatient with a diagnosis of psychotic syndrome
* on stable medication
* controlled as far as psychosis is concerned
* consenting to participate
Exclusion Criteria
* with other diagnoses
* not on stable medication
* in an unstable condition
* unwilling to participate in the study
18 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Evangelia Kouidi
Professor of Sports Medicine
Locations
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Sports Medicine Laboratory, Aristotle University of Thessaloniki
Thessaloniki, Thermi, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EH-44/2021
Identifier Type: -
Identifier Source: org_study_id
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