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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05056181
Other study ID # 872/CE Lazio 1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date July 2024

Study information

Verified date September 2021
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this project is to establish the acceptability of the PAI (physical activity intervention) to service users by evaluating if participants can be recruited into the study and if they complete the intervention. Secondary aims are to estimate if, compared with treatment as usual (TAU), the PAI intervention (1) positively impacts on subjects' psychiatric symptoms (2) succeeds in improving cardiovascular fitness performance. In addition, will be considered the impact of the PAI versus TAU on sleep behavior, quality of life, drug consumption, reduces sedentary behaviour and unscheduled readmissions to the department within 30 days and within 7 days after their dismission.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 2024
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of any SMI - Meeting any one of the following criteria as determined by a care co-ordinator: 1. Overweight 2. At risk for or have type 2 diabetes mellitus 3. In the clinician's view, have a sedentary lifestyle 4. Smoke tobacco - Ability to provide informed consent - Ability to understand Italian Exclusion Criteria: - under the age of 18 - not having a diagnosis of SMI - be unable to do exercises - be unable to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Activity
Physical activity

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients that will complete the study (Acceptability) to evaluate if participants can be recruited into the study and if they complete the intervention. 24-26 weeks
Secondary Anthropometric measures Body Max Index (BMI), in kg/m^2 24-26 weeks
Secondary Anthropometric measures height in centimeters 24-26 weeks
Secondary Anthropometric measures abdominal circumference in centimeters 24-26 weeks
Secondary Anthropometric measures weight in kilograms 24-26 weeks
Secondary Self-report sedentary behaviour and physical activity International Physical Activity Questionnaire (IPAQ) 24-26 weeks
Secondary Cardiorespiratory Fitness 6MWT 24-26 weeks
Secondary Sleep behavior Pittsburgh sleep quality index (PSQI) 24-26 weeks
Secondary Quality of life (QoL) The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) 24-26 weeks
Secondary Motivation to engage in physical activity Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) 24-26 weeks
Secondary Psychiatric symptoms brief psychiatric rating scale (BPRS) 24-26 weeks
Secondary Psychiatric symptoms Hamilton Depression Rating Scale (HAM-D) 24-26 weeks
Secondary Blood samples HIgh Density Lipoproteins (HDL) 24-26 weeks
Secondary Blood samples blood glucose levels 24-26 weeks
Secondary Blood samples insulin levels 24-26 weeks
Secondary Blood samples triglycerides 24-26 weeks
Secondary Blood samples C-reactive Protein (CRP) 24-26 weeks
Secondary Blood samples Low Density Lipoproteins (LDP) 24-26 weeks
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