MenPhys: Intervention Protocol for Physical Wellness in Mental Health

Study Overview
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Brief Summary
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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.

Official Title
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MenPhys: Intervention Protocol for Physical Wellness in Mental Health

Conditions
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Severe Mental Disorder

Intervention / Treatment
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* Other: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of any SMI Meeting any one of the following criteria as determined by a care co-ordinator: Overweight 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAI<br>Participants assigned to the PAI arm will receive brief information on the benefits of being more active and will be given information about the best way to training. They will receive conventional medical treatment. They will also participate in 2 weeks of training (12 sessions), plus telematic assistance of a specialized practitioner who will follow them during the post-discharge training sessions for a period of 12 weeks, with 3 workouts per week. | Other: Physical Activity<br>* Physical activity<br>|
| No Intervention: TAU<br>Participants assigned to the TAU arm will receive brief information on the benefits of being more active and will be given information about the best way to training. They will also receive conventional medical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measures | Body Max Index (BMI), in kg/m^2 | 24-26 weeks | 
| Anthropometric measures | height in centimeters | 24-26 weeks | 
| Anthropometric measures | abdominal circumference in centimeters | 24-26 weeks | 
| Anthropometric measures | weight in kilograms | 24-26 weeks | 
| Self-report sedentary behaviour and physical activity | International Physical Activity Questionnaire (IPAQ) | 24-26 weeks | 
| Cardiorespiratory Fitness | 6MWT | 24-26 weeks | 
| Sleep behavior | Pittsburgh sleep quality index (PSQI) | 24-26 weeks | 
| Quality of life (QoL) | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | 24-26 weeks | 
| Motivation to engage in physical activity | Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) | 24-26 weeks | 
| Psychiatric symptoms | brief psychiatric rating scale (BPRS) | 24-26 weeks | 
| Psychiatric symptoms | Hamilton Depression Rating Scale (HAM-D) | 24-26 weeks | 
| Blood samples | HIgh Density Lipoproteins (HDL) | 24-26 weeks | 
| Blood samples | blood glucose levels | 24-26 weeks | 
| Blood samples | insulin levels | 24-26 weeks | 
| Blood samples | triglycerides | 24-26 weeks | 
| Blood samples | C-reactive Protein (CRP) | 24-26 weeks | 
| Blood samples | Low Density Lipoproteins (LDP) | 24-26 weeks |