Clinical trial NCT06824584: Relationship Between Physical Fitness and Psychopathology, Cognition and Quality of Life in Patients Diagnosed With Schizophrenia: a Mixed Method Study.
Official title: Relationship Between Physical Fitness and Psychopathology, Cognition and Quality of Life in Patients Diagnosed With Schizophrenia: a Mixed Method Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Schizophrenia and Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
physical fitness
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Servicio Gallego de Salud
First posted: 2025-02-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. be over 18 years of age diagnosed with schizophrenia or schizoaffective disorder by a specialist physician.
2. be able to understand their involvement in the study when provided with the relevant information.
3. clinically stable, without behavioral disorganization that prevents participation in project activities and without suicidal ideation or suicide risk.
4. 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.

Exclusion Criteria:

1. 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).
2. being pregnant or in the puerperium period.
3. presenting in the last 3 months a moderate to severe comorbid substance abuse disorder that makes safe participation in the study impossible.
4. have been hospitalized for psychiatric or organic reasons in the 3 months prior to inclusion in the project.

Primary outcomes:
measure: The Modified Shuttle Walk Test (MSWT)
timeFrame: At baseline and after 3 months follow-up.
measure: The 5 repetitions Sit to Stand Test (5R STS)
timeFrame: At baseline and after 3 months follow-up.
measure: The handgrip strength
timeFrame: At baseline and after 3 months follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
Study officials:
References: