Psychotic DisordersPEPNCT07360665
Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics
A study testing Physical Exercise in people with Psychotic Disorders and Schizophrenia Spectrum Disorders (SSD), run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial summary
People with psychotic disorders, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Schizophrenia Spectrum Disorders (SSD), Severe Mental Illness
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2026to 30 Nov 2026
- 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
- Age 18 years or older;
- Clinical diagnosis of psychosis;
- Currently undergoing treatment with long-acting injectable antipsychotics (LAIs);
- Follow-up at the Antipsychotic Clinic of ULSTMAD;
- Certificate of autonomy issued by the treating psychiatrist, confirming the participant's capacity to engage in the study procedures;
- Ability to provide written informed consent, either personally or through a legal representative;
- (Experimental group only) Residence within a reasonable distance from the physical exercise intervention site to allow attendance at supervised sessions.
Who cannot join
- Attendance below 85% of the supervised exercise sessions (experimental group);
- Failure to complete the four main assessment time points;
- Withdrawal or lack of informed consent at any stage of the study;
- Not prescribed long-acting injectable antipsychotics (LAIs);
- Not affiliated with or followed at the Antipsychotic Clinic of ULSTMAD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Local Health Unit of Trás-os-Montes and Alto Douro
Vila Real, 5000
Dulce Amélia Maia, MD, 259300500, dulcefm@chtmad.min-saude.pt
dulcefm@chtmad.min-saude.pt
About this study
Official title: PEP - Physical Exercise for Psychosis: A Study Protocol
People with psychotic disorders, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Physical exercise has shown potential benefits for mental and physical health in this population; however, structured exercise programs implemented in real-world psychiatric services are still limited.
The purpose of this study is to evaluate the feasibility and clinical impact of a structured, multimodal physical exercise program for adults with psychosis who are receiving long-acting injectable antipsychotic treatment. The study aims to determine whether participation in a supervised exercise program can improve physical functioning, psychological well-being, and selected biological markers related to brain health and metabolism.
Read more
This study will be conducted in an outpatient psychiatric setting in Portugal and will include adults diagnosed with psychosis who are currently treated with long-acting injectable antipsychotics. Participants will be allocated to either an exercise group or a control group receiving usual care. The exercise program will last 24 weeks and will include aerobic, strength, mobility, and flexibility exercises, with supervised sessions conducted by qualified professionals.
Participants will be assessed at baseline, during the intervention, after completion of the program, and at follow-up. Assessments will include measures of physical function, body composition, psychological well-being, quality of life, and blood-based biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators.
The main hypothesis of this study is that individuals who participate in the physical exercise program will show improvements in physical function, mood, and overall well-being compared with those receiving usual care alone. The results of this study are expected to provide practical evidence to support the integration of structured physical exercise as an adjunct to routine psychiatric care for people with psychosis.
- Being tested
- Physical Exercise
- Medical subject headings
- Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Also called Multimodal Physical Exercise
The program will be multimodal, integrating various exercise components. The aerobic component will consist of activities like walking, cycling, and circuit training. The functional strength component will include 2 to 3 exercises for the lower limbs, 2 to 3 exercises for the upper limbs, 1 to 2 exercises for the trunk and abdominal muscles, as well as 1 to 2 multi-joint exercises like burpees, swing kettlebell, among others. Lastly, the program will also incorporate mobility, balance, and flexibility exercises, such as stretching, postures, and joint mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with psychosis who are receiving farmacological treatment and exercise program. | Experimental | Patients aged 18 years or older, diagnosed with psychosis, undergoing treatment with LAIs, and holding a certificate of autonomy issued by their psychiatrist, with the additional requirement for the experimental group to reside near the location of the physical exercise sessions. Receives: Other: Physical Exercise |
| Patients diagnosed with psychosis who are receiving farmacological treatment. | No intervention | Patients aged 18 years or older, diagnosed with psychosis, undergoing treatment with LAIs, and holding a certificate of autonomy issued by their psychiatrist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass/weight
Body mass/weight measured in kilograms using a calibrated scale.
Measured: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Body mass index (BMI)
BMI calculated as weight (kg) / height (m²)
Measured: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Body fat percentage
Body fat percentage assessed by electrical bioimpedance analysis
Measured: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Lean body mass
Lean body mass (kg) assessed by electrical bioimpedance analysis
Measured: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Sit-to-Stand Test _ 30s
Used to measure lower limb strength and endurance through the number of repetitions performed in a specific period.
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Handgrip Test
Used to assess upper limb muscle strength
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
European Health Interview Survey - Quality of Life 8-item Index (EUROHIS-QOL-8)
The European Health Interview Survey - Quality of Life 8-item Index (EUROHIS-QOL-8) is an 8-item self-report questionnaire assessing overall quality of life across physical, psychological, social, and environmental domains. Each item is rated on a 5-point Likert scale, resulting in a total score ranging from 8 to 40. Higher total scores indicate better perceived quality of life. The scale demonstrates good psychometric properties and is suitable for use in clinical and research settings.
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Patient Health Questionnaire-9 - PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered questionnaire designed to assess the severity of depressive symptoms based on the diagnostic criteria for major depressive episodes. Each item is scored on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 27. Higher total scores indicate greater severity of depressive symptoms. The PHQ-9 is widely used in clinical and research settings and demonstrates good psychometric properties.
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Positive and Negative Affect Scale (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire designed to assess affective states, comprising two independent 10-item subscales: Positive Affect (PANAS-PA) and Negative Affect (PANAS-NA). Each item is rated on a 5-point Likert scale (1-5), yielding subscale scores ranging from 10 to 50. Higher scores on the Positive Affect subscale indicate higher levels of positive affect, whereas higher scores on the Negative Affect subscale indicate higher levels of negative affect. The PANAS is widely used in clinical and research settings and demonstrates good psychometric properties.
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Serum Brain-Derived Neurotrophic Factor (BDNF) levels
Serum BDNF concentration quantified using standardized Human BDNF ELISA Kit (Abcam). BDNF is a key neurotrophic marker associated with neuroplasticity and treatment-related neurobiological adaptations. Units: ng/mL.
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Serum lipid profile
Assessment of serum lipid parameters including total cholesterol, HDL cholesterol, LDL cholesterol (direct or calculated), and triglycerides, according to hospital laboratory reference standards. Units: mg/dL.
Hospital laboratory references:
- Total cholesterol: < 200 mg/dL
- LDL cholesterol: < 130 mg/dL
- HDL cholesterol: > 60 mg/dL
- Triglycerides: < 150 mg/dL
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Glycemic and metabolic markers
Evaluation of fasting blood glucose and glycated hemoglobin (HbA1c) as indicators of glycemic control and metabolic health.
Units:
- Glucose: mg/dL
- HbA1c: %
Hospital reference values:
- Glucose: 74-106 mg/dL
- HbA1c: 4.0-6.0 %
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Serum Serotonin levels
Quantification of serotonin concentration in serum using standardized laboratory procedures. Higher or lower concentrations will be interpreted as neurochemical modulation potentially associated with the exercise intervention and antipsychotic treatment.
Unit: ng/mL
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Serum Dopamine levels
Quantification of dopamine concentration in serum using standardized laboratory procedures. Changes in dopamine concentration across timepoints will be analyzed as a marker of neurochemical modulation potentially associated with the exercise intervention and antipsychotic treatment.
Unit: ng/mL or pg/mL
Measured: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Secondary outcomes (1)
Height
Height measured in meters using stadiometer (baseline only, if applicable)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De Trás-Os-Montes E Alto Douro, E.P.E.
- Responsible party
- Principal investigator, Sofia Silva, University of Trás-os-Montes and Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360665
- Sponsor's protocol ID
- 2024.04489.BDANA
- Other IDs
- CES REG. 1612
- Acronym
- PEP
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The dataset includes sensitive clinical, functional, and health-related information collected in a hospital setting. Data will be used exclusively for the purposes defined in the approved study protocol and in accordance with institutional ethical approval and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEP - Physical Exercise for Psychosis: A Study Protocol
- ClinicalTrials.gov ID
- NCT07360665
- Acronym / sponsor ID
- PEP / 2024.04489.BDANA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Collaborators
- Centro Hospitalar De Trás-Os-Montes E Alto Douro, E.P.E.
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
People with psychotic disorders, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Physical exercise has shown potential benefits for mental and physical health in this population; however, structured exercise programs implemented in real-world psychiatric services are still limited.
The purpose of this study is to evaluate the feasibility and clinical impact of a structured, multimodal physical exercise program for adults with psychosis who are receiving long-acting injectable antipsychotic treatment. The study aims to determine whether participation in a supervised exercise program can improve physical functioning, psychological well-being, and selected biological markers related to brain health and metabolism.
This study will be conducted in an outpatient psychiatric setting in Portugal and will include adults diagnosed with psychosis who are currently treated with long-acting injectable antipsychotics. Participants will be allocated to either an exercise group or a control group receiving usual care. The exercise program will last 24 weeks and will include aerobic, strength, mobility, and flexibility exercises, with supervised sessions conducted by qualified professionals.
Participants will be assessed at baseline, during the intervention, after completion of the program, and at follow-up. Assessments will include measures of physical function, body composition, psychological well-being, quality of life, and blood-based biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators.
The main hypothesis of this study is that individuals who participate in the physical exercise program will show improvements in physical function, mood, and overall well-being compared with those receiving usual care alone. The results of this study are expected to provide practical evidence to support the integration of structured physical exercise as an adjunct to routine psychiatric care for people with psychosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with psychosis who are receiving farmacological treatment and exercise program. | Experimental | Other: Physical ExercisePatients aged 18 years or older, diagnosed with psychosis, undergoing treatment with LAIs, and holding a certificate of autonomy issued by their psychiatrist, with the additional requirement for the experimental group to reside near the location of the physical exercise sessions. |
| Patients diagnosed with psychosis who are receiving farmacological treatment. | No intervention | –Patients aged 18 years or older, diagnosed with psychosis, undergoing treatment with LAIs, and holding a certificate of autonomy issued by their psychiatrist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older;
- Clinical diagnosis of psychosis;
- Currently undergoing treatment with long-acting injectable antipsychotics (LAIs);
- Follow-up at the Antipsychotic Clinic of ULSTMAD;
- Certificate of autonomy issued by the treating psychiatrist, confirming the participant's capacity to engage in the study procedures;
Key exclusion criteria (5 listed)
- Attendance below 85% of the supervised exercise sessions (experimental group);
- Failure to complete the four main assessment time points;
- Withdrawal or lack of informed consent at any stage of the study;
- Not prescribed long-acting injectable antipsychotics (LAIs);
- Not affiliated with or followed at the Antipsychotic Clinic of ULSTMAD.
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 |
|---|---|---|
| Physical ExerciseAlso: Multimodal Physical ExerciseThe program will be multimodal, integrating various exercise components. The aerobic component will consist of activities like walking, cycling, and circuit training. The functional strength component will include 2 to 3 exercises for the lower limbs, 2 to 3 exercises for the upper limbs, 1 to 2 exercises for the trunk and abdominal muscles, as well as 1 to 2 multi-joint exercises like burpees, swing kettlebell, among others. Lastly, the program will also incorporate mobility, balance, and flexibility exercises, such as stretching, postures, and joint mobilization. | Other | Patients diagnosed with psychosis who are receiving farmacological treatment and exercise program. |
Primary outcome
Body mass/weight
Time frame: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Body mass/weight measured in kilograms using a calibrated scale.
Body mass index (BMI)
Time frame: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
BMI calculated as weight (kg) / height (m²)
Body fat percentage
Time frame: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Body fat percentage assessed by electrical bioimpedance analysis
Lean body mass
Time frame: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up
Lean body mass (kg) assessed by electrical bioimpedance analysis
Sit-to-Stand Test _ 30s
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Used to measure lower limb strength and endurance through the number of repetitions performed in a specific period.
Handgrip Test
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Used to assess upper limb muscle strength
European Health Interview Survey - Quality of Life 8-item Index (EUROHIS-QOL-8)
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
The European Health Interview Survey - Quality of Life 8-item Index (EUROHIS-QOL-8) is an 8-item self-report questionnaire assessing overall quality of life across physical, psychological, social, and environmental domains. Each item is rated on a 5-point Likert scale, resulting in a total score ranging from 8 to 40. Higher total scores indicate better perceived quality of life. The scale demonstrates good psychometric properties and is suitable for use in clinical and research settings.
Patient Health Questionnaire-9 - PHQ-9
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered questionnaire designed to assess the severity of depressive symptoms based on the diagnostic criteria for major depressive episodes. Each item is scored on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 27. Higher total scores indicate greater severity of depressive symptoms. The PHQ-9 is widely used in clinical and research settings and demonstrates good psychometric properties.
Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire designed to assess affective states, comprising two independent 10-item subscales: Positive Affect (PANAS-PA) and Negative Affect (PANAS-NA). Each item is rated on a 5-point Likert scale (1-5), yielding subscale scores ranging from 10 to 50. Higher scores on the Positive Affect subscale indicate higher levels of positive affect, whereas higher scores on the Negative Affect subscale indicate higher levels of negative affect. The PANAS is widely used in clinical and research settings and demonstrates good psychometric properties.
Serum Brain-Derived Neurotrophic Factor (BDNF) levels
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Serum BDNF concentration quantified using standardized Human BDNF ELISA Kit (Abcam). BDNF is a key neurotrophic marker associated with neuroplasticity and treatment-related neurobiological adaptations. Units: ng/mL.
Serum lipid profile
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Assessment of serum lipid parameters including total cholesterol, HDL cholesterol, LDL cholesterol (direct or calculated), and triglycerides, according to hospital laboratory reference standards. Units: mg/dL. Hospital laboratory references: * Total cholesterol: < 200 mg/dL * LDL cholesterol: < 130 mg/dL * HDL cholesterol: > 60 mg/dL * Triglycerides: < 150 mg/dL
Glycemic and metabolic markers
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Evaluation of fasting blood glucose and glycated hemoglobin (HbA1c) as indicators of glycemic control and metabolic health. Units: * Glucose: mg/dL * HbA1c: % Hospital reference values: * Glucose: 74-106 mg/dL * HbA1c: 4.0-6.0 %
Serum Serotonin levels
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Quantification of serotonin concentration in serum using standardized laboratory procedures. Higher or lower concentrations will be interpreted as neurochemical modulation potentially associated with the exercise intervention and antipsychotic treatment. Unit: ng/mL
Serum Dopamine levels
Time frame: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up
Quantification of dopamine concentration in serum using standardized laboratory procedures. Changes in dopamine concentration across timepoints will be analyzed as a marker of neurochemical modulation potentially associated with the exercise intervention and antipsychotic treatment. Unit: ng/mL or pg/mL
1 secondary outcome
Height
Time frame: Baseline
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 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The dataset includes sensitive clinical, functional, and health-related information collected in a hospital setting. Data will be used exclusively for the purposes defined in the approved study protocol and in accordance with institutional ethical approval and data protection regulations.
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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.
Local Health Unit of Trás-os-Montes and Alto Douro
Vila Real, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Psychotic Disorders and Schizophrenia Spectrum Disorders (SSD), run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
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 7 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 29 Apr 2026. 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 Portugal. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass/weight (time frame: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up). 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 29 Apr 2026.