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

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 Overview

• Status: Not yet recruiting
• Conditions: Severe Mental Disorder
• Intervention / Treatment: Other: Physical Activity

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAI; 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; Physical activity
No Intervention: TAU; 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?

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 872/CE Lazio 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No