Severe Mental Disorder
Conditions
Brief 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.
Interventions
OTHERPhysical Activity
Physical activity
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients that will complete the study (Acceptability) | 24-26 weeks | to evaluate if participants can be recruited into the study and if they complete the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report sedentary behaviour and physical activity | 24-26 weeks | International Physical Activity Questionnaire (IPAQ) |
| Cardiorespiratory Fitness | 24-26 weeks | 6MWT |
| Sleep behavior | 24-26 weeks | Pittsburgh sleep quality index (PSQI) |
| Anthropometric measures | 24-26 weeks | Body Max Index (BMI), in kg/m\^2 |
| Motivation to engage in physical activity | 24-26 weeks | Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) |
| Psychiatric symptoms | 24-26 weeks | brief psychiatric rating scale (BPRS) |
| Blood samples | 24-26 weeks | HIgh Density Lipoproteins (HDL) |
| Quality of life (QoL) | 24-26 weeks | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) |
Outcome results
None listed