Psychotic DisorderNCT07113119
Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
A study testing Exercise intervention in people with Psychotic Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 4 Aug 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being an adult
- inpatient with a diagnosis of psychotic syndrome
- on stable medication
- controlled as far as psychosis is concerned
- consenting to participate
Who cannot join
- adolescents
- with other diagnoses
- not on stable medication
- in an unstable condition
- unwilling to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Theochari Victoria contact
Greece1 site, 1 recruiting
- Recruiting
Sports Medicine Laboratory, Aristotle University of Thessaloniki
Thessaloniki, Thermi
Evangelia Kouidi, +302310992189, kouidi@phed.auth.gr
Theochari Victoria, victoriatheohari@gmail.com
About this study
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.
- Conditions
- Psychotic Disorder
- Being tested
- Exercise intervention
- Keywords
- Exercise, Functional ability, Quality of life, Pilates
- Medical subject headings
- Psychotic Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A: EXERCISE GROUP | Experimental | Exercise group: 1-year mixed-type exercise training program Receives: Other: Exercise intervention |
| GROUP B: CONTROL GROUP | No intervention | Control Group: 1-year normal physical activity, without participating in organized sports programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
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).
Measured: Follow-up assessment, 12 months post- baseline
Handgrip Strength
Evaluation of the isometric handgrip strength using a hand dynamometer
Measured: Baseline
Handgrip Strength
Evaluation of the isometric handgrip strength using a hand dynamometer
Measured: Follow-up assessment, 12 months post- baseline
Sit-and-Reach Test
Evaluation of flexibility using sit- and- reach test
Measured: Baseline
Sit-and-Reach Test
Evaluation of flexibility using sit- and- reach test
Measured: Follow-up assessment, 12 months post- baseline
30 -second Sit-to-stand test (STS)
Evaluation of functional capacity and mobility using 30-second STS
Measured: Baseline
30 -second Sit-to-stand test (STS)
Evaluation of functional capacity and mobility using 30-second STS
Measured: Follow-up assessment, 12 months post- baseline
Six- Minute Walking Test
Estimation of aerobic capacity through six minute walking test
Measured: Baseline
Six- Minute Walking Test
Estimation of aerobic capacity through six minute walking test
Measured: Follow-up assessment, 12 months post- baseline
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Measured: Baseline
Berg Balance Scale Test
Evaluation of balance using Berg Balance Scale Test
Measured: Follow-up assessment, 12 months post- baseline
Short form Quality of Life (SF-36)
Assessment of Quality of Life using SF-36
Measured: Baseline
Short form Quality of Life (SF-36)
Assessment of Quality of Life using SF-36
Measured: Follow-up assessment, 12 months post- baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start4 Aug 2024
- Primary completion4 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113119
- Sponsor's protocol ID
- EH-44/2021
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT07113119
- Acronym / sponsor ID
- EH-44/2021
- Conditions
- Psychotic Disorder
- Keywords
- Exercise, Functional ability, Quality of life, Pilates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 4 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A: EXERCISE GROUP | Experimental | Other: Exercise interventionExercise group: 1-year mixed-type exercise training program |
| GROUP B: CONTROL GROUP | No intervention | –Control Group: 1-year normal physical activity, without participating in organized sports programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being an adult
- inpatient with a diagnosis of psychotic syndrome
- on stable medication
- controlled as far as psychosis is concerned
- consenting to participate
Key exclusion criteria (5 listed)
- adolescents
- with other diagnoses
- not on stable medication
- in an unstable condition
- unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionPatients 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. | Other | GROUP A: EXERCISE GROUP |
Primary outcome
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).
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).
Handgrip Strength
Time frame: Baseline
Evaluation of the isometric handgrip strength using a hand dynamometer
Handgrip Strength
Time frame: Follow-up assessment, 12 months post- baseline
Evaluation of the isometric handgrip strength using a hand dynamometer
Sit-and-Reach Test
Time frame: Baseline
Evaluation of flexibility using sit- and- reach test
Sit-and-Reach Test
Time frame: Follow-up assessment, 12 months post- baseline
Evaluation of flexibility using sit- and- reach test
30 -second Sit-to-stand test (STS)
Time frame: Baseline
Evaluation of functional capacity and mobility using 30-second STS
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
Six- Minute Walking Test
Time frame: Baseline
Estimation of aerobic capacity through six minute walking test
Six- Minute Walking Test
Time frame: Follow-up assessment, 12 months post- baseline
Estimation of aerobic capacity through six minute walking test
Berg Balance Scale Test
Time frame: Baseline
Evaluation of balance using Berg Balance Scale Test
Berg Balance Scale Test
Time frame: Follow-up assessment, 12 months post- baseline
Evaluation of balance using Berg Balance Scale Test
Short form Quality of Life (SF-36)
Time frame: Baseline
Assessment of Quality of Life using SF-36
Short form Quality of Life (SF-36)
Time frame: Follow-up assessment, 12 months post- baseline
Assessment of Quality of Life using SF-36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theochari Victoria contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Psychotic Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evangelia Kouidi (+302310992189, kouidi@phed.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.