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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04443374
Other study ID # 24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date August 2, 2020

Study information

Verified date August 2020
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties.


Description:

The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For cross-cultural adaptation and validation procedure, developers' manual in the official site will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of the SIMPAQ to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the International Physical Activity-Short Form (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check the validity.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 2, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Aged between 18 and 60 years Being a volunteer to participate Being an outpatient or inpatient at the place of the study Being diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction according to DSM-5 or ICD.

Exclusion Criteria:

Having cognitive impairment Having disabilities in understanding, speaking and reading Turkish Having vision and / or hearing problems

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Simple Physical Activity Questionnaire The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week). Baseline (First assessment)
Secondary Simple Physical Activity Questionnaire The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week). Within a 5-to-7-day period after the first assessment (Second assessment)
Secondary International Physical Activity Questionnaire-Short Form International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a self-report questionnaire that assesses PA in the last 7 days. IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week. Baseline (First assessment)
Secondary Brief Psychiatric Rating Scale Brief Psychiatric Rating Scale (BPRS) is a valid 18-item quantitative scale for assessing psychopathology and its severity. Each item is measured on a five-point scale (0 = none to 4 = very severe), with lower scores meaning a lower severity of the symptom. Baseline (First assessment)
Secondary DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult (DSM XC) comprises 23 self-rated symptoms that capture 13 mental health domains. Respondents indicate how much (or how often) they have been bothered by each symptom in the prior two weeks using a five-point response scale (none, not at all to severe, nearly every day). A score of 2 or higher in most domains, except substance use (score of 1 or higher) is suggestive of clinically-relevant mental health problems. Baseline (First assessment)
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