"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Severe Mental Disorder
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 80
- Primary Endpoint
- Percentage of patients that will complete the study (Acceptability)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Paolo Flocco
adjunct professor
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of any SMI
- •Meeting any one of the following criteria as determined by a care co-ordinator:
- •At risk for or have type 2 diabetes mellitus
- •In the clinician's view, have a sedentary lifestyle
- •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
Outcomes
Primary Outcomes
Percentage of patients that will complete the study (Acceptability)
Time Frame: 24-26 weeks
to evaluate if participants can be recruited into the study and if they complete the intervention.
Secondary Outcomes
- Anthropometric measures(24-26 weeks)
- Cardiorespiratory Fitness(24-26 weeks)
- Sleep behavior(24-26 weeks)
- Quality of life (QoL)(24-26 weeks)
- Motivation to engage in physical activity(24-26 weeks)
- Psychiatric symptoms(24-26 weeks)
- Blood samples(24-26 weeks)
- Self-report sedentary behaviour and physical activity(24-26 weeks)