Relationship Between Physical Fitness and Psychopathology, Cognition and Quality of Life in Patients Diagnosed With Schizophrenia: a Mixed Method Study.

NCT06824584 | Active Not Recruiting

• 1 other identifier: 2024/013
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; physical fitness

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At baseline and after 3 months follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Servicio Gallego de Salud: collaborator

Study Sites (1)

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 19, 2024
• Primary Completion: July 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

ES (1)