Physical Activity Level in Psychosis Patients

Psychosis Clinical Trial

Official title:

The Effect of Physical Activity Level on Social Participation, Functioning and Quality of Life in Psychosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06408740
• Other study ID #: 2023-129
• Status: Completed
• Start date: September 20, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis.

Description:

Positive and negative symptoms of schizophrenia will be assessed using the Positive and Negative Syndrome Scale, depression will be assessed using the Calgary Depression in Schizophrenia Scale, medication side effects will be assessed using the Glasgow Antipsychotic Side Effect Rating Scale, physical activity level will be assessed using the International Physical Activity Form, social participation will be assessed using the Social Participation Questionnaire, functioning will be assessed using the Brief Functioning Assessment Scale and quality of life will be assessed using the Nottingham Health Profile. The assessments are planned to last 30 minutes for each participant. Participants will be assessed only once and will not be reassessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with schizophrenia and other psychotic disorders according to DSM-V criteria (brief psychosis disorder, schizophreniform disorder, schizoaffective disorder, other disorder with psychosis within the scope of another defined schizophrenia and other disorders with psychosis, other disorders with psychosis within the scope of undefined schizophrenia and other disorders with psychosis), who have had their first episode, who are receiving outpatient treatment

• Whose duration of illness is longer than 2 years

• Being between the ages of 18-65

• Being literate

Exclusion Criteria:

• The participant is in a period of active illness that makes it difficult to conduct research (Positive and Negative Syndrome Scale>70 scale points, Calgary Depression in Schizophrenia Scale score >11 scale points)

• Comorbid psychiatric illness

• The patient has an acute or chronic physical illness that impairs the general medical condition and a disease that will affect cognitive functions (neurological, neoplastic, endocrine and immune disorders, infection, epilepsy or any neurological disease, etc.).

• The patient has a physical illness (loss of limbs, paralysis, etc.) that requires additional care and causes significant disability

• Alcohol and substance use disorder

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylül University	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale	The scale is a 30-item semi-structured interview scale with a seven-point severity rating. In our study, individuals scoring below 70 points were included to confirm that the participants were not in the active disease period.	6 months
Primary	Calgary Schizophrenia Depression Scale	The scale is an interviewer-rated scale and consists of 9 items in four-point Likert type. The cut-off score for schizophrenia accompanied by depressive disorder was determined as 11/12. In our study, individuals scoring below 11 points were included to confirm that the participants were not in a depressive episode.	6 months
Primary	Glasgow Antipsychotic Side Effect Rating Scale	It is a 22-item self-report scale about the side effects of antipsychotics. An increase in the scale score indicates an increase in the severity of side effects	6 months
Primary	International Physical Activity Form	This form consists of seven questions and provides information on sitting, walking, moderately vigorous activities and time spent in vigorous activities. The calculation of the total score of the short form includes the sum of duration (minutes) and frequency (days) of walking, moderately vigorous activity and vigorous activity. The sitting score (sedentary behavior level) is calculated separately. Physical activity levels are classified as physically inactive/inactive (<600 MET-min/week), physically inactive/minimally active (600-3000 MET-min/week) and physically active/very active (>3000 MET-min/week).	6 months
Primary	Community Participation Survey	It is a method used to observe an individual's participation in the community. It consists of 15 headings. It is used to assess individuals' home, family life, social activities and work activities. Home activity is 10 points; social activity is 12 points and work activity is 7 points. The total score from 0 to 29 is calculated.	6 months
Primary	Brief Functioning Assessment Scale	This scale, which will be used by the researchers, consists of questions designed to measure the extent to which patients experienced difficulties in autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relations, and leisure time activities during the study. The 24-item scale allows the measurement of 6 different domains of specific functioning: autonomy, occupational, cognitive, financial, interpersonal and leisure activities. The scale provides a total score as well as scores specific to sub-functioning domains. Items are scored according to their severity on a scale of 0 to 4. (0) = no difficulty, (1) = mild difficulty, (2) = moderate difficulty, (3) = severe difficulty. Scores on the scale can range from 0 to 72. A total score above 11 indicates a significant loss of functioning.	6 months
Primary	Nottingham Health Profile	It is used to assess the quality of life of individuals. It consists of 2 parts. The first part includes six categories of energy, pain, physical mobility, sleep, emotional reactions and social isolation and consists of 38 different questions with yes or no answers. The second part consists of 7 questions. The questionnaire asks about current complaints. Positive answers to specific areas are used to assess severity or the sum of the six categories can be given as a profile. The total score for each of the 6 sub-parameters is between 0 and 100 and the total score for the total score is between 0 and 600. A high score indicates poor quality of life.	6 months