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

Severe Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05056181
• Other study ID #: 872/CE Lazio 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: July 2024

Study information

• Verified date: September 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Mental Disorders
• Severe Mental Disorder

Intervention

Other:
• Physical Activity
Physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

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