Schizophrenia and Schizoaffective DisorderCOFESQNCT06824584
Relationship Between Physical Fitness and Psychopathology, Cognition and Quality of Life in Patients Diagnosed With Schizophrenia: a Mixed Method Study.
An observational study of Schizophrenia and Schizoaffective Disorder, run by Universidade da Coruña at 1 site in Spain.
Trial summary
The goal of this observational study is to assess the physical fitness and the influence of possible factors (disease symptomatology, cognitive status, patient functioning and degree of perceived quality of life) on patients diagnosed with schizophrenia and schizoaffective disorder older than 18 years in an outpatient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia and Schizoaffective Disorder
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 19 Mar 2024to Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: The study population will be composed of patients diagnosed with schizophrenia or schizoaffective disorder under follow-up in outpatient devices in the health area of Lugo.
Who may be able to join
- be over 18 years of age diagnosed with schizophrenia or schizoaffective disorder by a specialist physician.
- be able to understand their involvement in the study when provided with the relevant information.
- clinically stable, without behavioral disorganization that prevents participation in project activities and without suicidal ideation or suicide risk.
- if they are under pharmacological treatment, they must be stable in the type of drug and its dosage and posology for at least 4 weeks.
Who cannot join
- presenting pathologies that suppose a contraindication for the practice of supervised physical exercise (neurological diseases that suppose a cognitive deterioration such as to hinder the execution of tasks, musculoskeletal diseases that hinder stability and gait, or cardiovascular or metabolic diseases that suppose a risk for the individual).
- being pregnant or in the puerperium period.
- presenting in the last 3 months a moderate to severe comorbid substance abuse disorder that makes safe participation in the study impossible.
- have been hospitalized for psychiatric or organic reasons in the 3 months prior to inclusion in the project.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to assess the physical fitness and the influence of possible factors (disease symptomatology, cognitive status, patient functioning and degree of perceived quality of life) on patients diagnosed with schizophrenia and schizoaffective disorder older than 18 years in an outpatient setting. The main question it aims to answer is:
Do the symptoms of the illness influence the level of physical fitness of patients?
Participants will complete a series of questionnaires assessing their cognitive status, perceived quality of life and disease severity, and physical activity assessments to measure their cardiovascular endurance and muscular power.
Read the detailed description
A mixed-methods research design will be carried out. Two different study designs will be used:
- Stage 1: Cross-sectional study: During the first 3 months, recruitment will start. This task will be carried out by the nurses of the mental health unit and by the director of the psycho-social and labor rehabilitation center of the Alume association, located in Lugo. If the patient agrees to participate, he or she will have to give written consent by signing the patient information sheet provided. If the patient has a legal representative, he or she should also provide written informed consent. Over the next 3 months, participants will be evaluated. Principal investigator will contact them via telephone or online texting (depending on each participant's individual choice) to meet them at the gym where the research team will conduct patients' assessments. An initial anamnesis will be performed containing questions related to the patient's sociodemographic data and to questions related to their illness. Along with this first step, anthropometric measurements will be taken for each individual, both with manual measurements. Then, each participant will complete a self-reported questionnaire on their quality of life and level of physical activity. The remaining assessments of psychopathology, cognitive status and physical fitness will be guided and supervised by members of the research team.
- Stage 2: Longitudinal study of one prospective cohort with pre-post analysis. After this first phase, during the following 3 months, patients will be asked to complete a weekly record reflecting their mood, level of physical activity and medication changes (if applicable). A weekly reminder will be sent to each participant in the format chosen by each individual (message, e-mail or phone call) to complete the required information (through questionnaires in "Forms" format or verbally in the case of a phone call). During these weeks, they will be asked to take a one-week objective measurement of their daily physical activity. Those who accept will wear an accelerometer that will quantify their daily activity. Once the follow-up period is completed, the patients will be scheduled again for three new assessment sessions, in which the same tests and scales as in the previous phase will be executed.
- Keywords
- schizophrenia, schizoaffective disorder, physical fitness
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Shuttle Walk Test (MSWT)
requires the patient to walk/run a 10m course (delimited 0.5m from each end by a cone) at a speed that increases 0.6 km/h every minute. The start of the race is marked by a triple beep and each lap is indicated by a single beep. At the conclusion of each level, patients were instructed to increase their speed slightly and reminded that they were free to accelerate at any time during the test. The trial concluded under the following conditions: (1) the participant became too breathless to sustain the prescribed pace, (2) the participant deviated more than 0.5 m from the cone upon the beep, (3) the participant attained a heart rate exceeding 85% of their age-predicted maximum, or (4) in case the patient reported symptoms such as chest pain, angina, dizziness, mental confusion, or severe muscular exhaustion. With the meters performed in the test, we will estimate the maximum oxygen consumption (VO2max), using the formula proposed by Tous-Espelosin et al. in 2021.
Measured: At baseline and after 3 months follow-up.
The 5 repetitions Sit to Stand Test (5R STS)
Participants will be instructed to sit in an armless chair of standard height (48 cm) with a hard seat, placed firmly against a wall. They will be required to cross their arms over their chest and keep their feet flat on the floor, wearing stable footwear throughout the test. Participants will be asked to stand up and sit down, landing firmly on the seat, five times as quickly as possible on the command "go". If the patient performs the test in 30 seconds or more, this time will be noted, and the test score will be recorded as 30 seconds. Using the Powerfrail app, the examiner will record the test performance on video to time the five repetitions, in addition to calculating the muscle power in W/kg.
Measured: At baseline and after 3 months follow-up.
The handgrip strength
will be measured with a dynamometer (Takei model) following a standardized methodology developed by the University of Southampton in 2011, based on the recommendations of the American Society of Hand Therapists (ASHT). The patient will be seated in a chair with legs, backrest and arms fixed, forearms on the arms of the chair and wrist in neutral position with the thumb up. The patient will perform a measurement first with the right hand, then with the left hand and then repeat the procedure 2 more times. The best of the six measurements will be used for statistical analysis.
Measured: At baseline and after 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start19 Mar 2024
- Primary completionJul 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Schizoaffective 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Gallego de Salud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824584
- Sponsor's protocol ID
- 2024/013
- Acronym
- COFESQ
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Physical Fitness and Psychopathology, Cognition and Quality of Life in Patients Diagnosed With Schizophrenia: a Mixed Method Study.
- ClinicalTrials.gov ID
- NCT06824584
- Acronym / sponsor ID
- COFESQ / 2024/013
- Keywords
- schizophrenia, schizoaffective disorder, physical fitness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Servicio Gallego de Salud
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Feb 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.
The goal of this observational study is to assess the physical fitness and the influence of possible factors (disease symptomatology, cognitive status, patient functioning and degree of perceived quality of life) on patients diagnosed with schizophrenia and schizoaffective disorder older than 18 years in an outpatient setting. The main question it aims to answer is:
Do the symptoms of the illness influence the level of physical fitness of patients?
Participants will complete a series of questionnaires assessing their cognitive status, perceived quality of life and disease severity, and physical activity assessments to measure their cardiovascular endurance and muscular power.
Detailed description
A mixed-methods research design will be carried out. Two different study designs will be used:
- Stage 1: Cross-sectional study: During the first 3 months, recruitment will start. This task will be carried out by the nurses of the mental health unit and by the director of the psycho-social and labor rehabilitation center of the Alume association, located in Lugo. If the patient agrees to participate, he or she will have to give written consent by signing the patient information sheet provided. If the patient has a legal representative, he or she should also provide written informed consent. Over the next 3 months, participants will be evaluated. Principal investigator will contact them via telephone or online texting (depending on each participant's individual choice) to meet them at the gym where the research team will conduct patients' assessments. An initial anamnesis will be performed containing questions related to the patient's sociodemographic data and to questions related to their illness. Along with this first step, anthropometric measurements will be taken for each individual, both with manual measurements. Then, each participant will complete a self-reported questionnaire on their quality of life and level of physical activity. The remaining assessments of psychopathology, cognitive status and physical fitness will be guided and supervised by members of the research team.
- Stage 2: Longitudinal study of one prospective cohort with pre-post analysis. After this first phase, during the following 3 months, patients will be asked to complete a weekly record reflecting their mood, level of physical activity and medication changes (if applicable). A weekly reminder will be sent to each participant in the format chosen by each individual (message, e-mail or phone call) to complete the required information (through questionnaires in "Forms" format or verbally in the case of a phone call). During these weeks, they will be asked to take a one-week objective measurement of their daily physical activity. Those who accept will wear an accelerometer that will quantify their daily activity. Once the follow-up period is completed, the patients will be scheduled again for three new assessment sessions, in which the same tests and scales as in the previous phase will be executed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of patients diagnosed with schizophrenia or schizoaffective disorder under follow-up in outpatient devices in the health area of Lugo.
Key inclusion criteria (4 listed)
- be over 18 years of age diagnosed with schizophrenia or schizoaffective disorder by a specialist physician.
- be able to understand their involvement in the study when provided with the relevant information.
- clinically stable, without behavioral disorganization that prevents participation in project activities and without suicidal ideation or suicide risk.
- if they are under pharmacological treatment, they must be stable in the type of drug and its dosage and posology for at least 4 weeks.
Key exclusion criteria (4 listed)
- presenting pathologies that suppose a contraindication for the practice of supervised physical exercise (neurological diseases that suppose a cognitive deterioration such as to hinder the execution of tasks, musculoskeletal diseases that hinder stability and gait, or cardiovascular or metabolic diseases that suppose a risk for the individual).
- being pregnant or in the puerperium period.
- presenting in the last 3 months a moderate to severe comorbid substance abuse disorder that makes safe participation in the study impossible.
- have been hospitalized for psychiatric or organic reasons in the 3 months prior to inclusion in the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Modified Shuttle Walk Test (MSWT)
Time frame: At baseline and after 3 months follow-up.
requires the patient to walk/run a 10m course (delimited 0.5m from each end by a cone) at a speed that increases 0.6 km/h every minute. The start of the race is marked by a triple beep and each lap is indicated by a single beep. At the conclusion of each level, patients were instructed to increase their speed slightly and reminded that they were free to accelerate at any time during the test. The trial concluded under the following conditions: (1) the participant became too breathless to sustain the prescribed pace, (2) the participant deviated more than 0.5 m from the cone upon the beep, (3) the participant attained a heart rate exceeding 85% of their age-predicted maximum, or (4) in case the patient reported symptoms such as chest pain, angina, dizziness, mental confusion, or severe muscular exhaustion. With the meters performed in the test, we will estimate the maximum oxygen consumption (VO2max), using the formula proposed by Tous-Espelosin et al. in 2021.
The 5 repetitions Sit to Stand Test (5R STS)
Time frame: At baseline and after 3 months follow-up.
Participants will be instructed to sit in an armless chair of standard height (48 cm) with a hard seat, placed firmly against a wall. They will be required to cross their arms over their chest and keep their feet flat on the floor, wearing stable footwear throughout the test. Participants will be asked to stand up and sit down, landing firmly on the seat, five times as quickly as possible on the command "go". If the patient performs the test in 30 seconds or more, this time will be noted, and the test score will be recorded as 30 seconds. Using the Powerfrail app, the examiner will record the test performance on video to time the five repetitions, in addition to calculating the muscle power in W/kg.
The handgrip strength
Time frame: At baseline and after 3 months follow-up.
will be measured with a dynamometer (Takei model) following a standardized methodology developed by the University of Southampton in 2011, based on the recommendations of the American Society of Hand Therapists (ASHT). The patient will be seated in a chair with legs, backrest and arms fixed, forearms on the arms of the chair and wrist in neutral position with the thumb up. The patient will perform a measurement first with the right hand, then with the left hand and then repeat the procedure 2 more times. The best of the six measurements will be used for statistical analysis.
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 13 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Universidade da Coruña at 1 site in Spain.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Modified Shuttle Walk Test (MSWT) (time frame: At baseline and after 3 months follow-up.). The study lists 3 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 13 Feb 2025.