Severe Mental Disorder Clinical Trial
Official title:
"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
Verified date | September 2021 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
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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