"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"

University of Roma La Sapienza80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Severe Mental Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24-26 weeks

Secondary Outcomes

Anthropometric measures

Body Max Index (BMI), in kg/m\^2

Time frame: 24-26 weeks

Anthropometric measures

height in centimeters

Time frame: 24-26 weeks

Anthropometric measures

abdominal circumference in centimeters

Time frame: 24-26 weeks

Anthropometric measures

weight in kilograms

Time frame: 24-26 weeks

Self-report sedentary behaviour and physical activity

International Physical Activity Questionnaire (IPAQ)

Time frame: 24-26 weeks

Cardiorespiratory Fitness

6MWT

Time frame: 24-26 weeks

Sleep behavior

Pittsburgh sleep quality index (PSQI)

Time frame: 24-26 weeks

Quality of life (QoL)

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

Time frame: 24-26 weeks

Motivation to engage in physical activity

Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)

Time frame: 24-26 weeks

Psychiatric symptoms

brief psychiatric rating scale (BPRS)

Time frame: 24-26 weeks

Psychiatric symptoms

Hamilton Depression Rating Scale (HAM-D)

Time frame: 24-26 weeks

Blood samples

HIgh Density Lipoproteins (HDL)

Time frame: 24-26 weeks

Blood samples

blood glucose levels

Time frame: 24-26 weeks

Blood samples

insulin levels

Time frame: 24-26 weeks

Blood samples

triglycerides

Time frame: 24-26 weeks

Blood samples

C-reactive Protein (CRP)

Time frame: 24-26 weeks

Blood samples

Low Density Lipoproteins (LDP)

Time frame: 24-26 weeks