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

Not Applicable

• Conditions: Severe Mental Disorder
• Interventions: Other: Physical Activity

• Registration Number: NCT05056181
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-18
• Last Update Submitted: 2021-09-18
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Study Start: 2021-10
• Primary Completion: 2023-09
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAI	Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients that will complete the study (Acceptability)	24-26 weeks	to evaluate if participants can be recruited into the study and if they complete the intervention.

Secondary Outcome Measures

Name	Time	Method
Anthropometric measures	24-26 weeks	weight in kilograms
Cardiorespiratory Fitness	24-26 weeks	6MWT
Sleep behavior	24-26 weeks	Pittsburgh sleep quality index (PSQI)
Quality of life (QoL)	24-26 weeks	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Motivation to engage in physical activity	24-26 weeks	Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Psychiatric symptoms	24-26 weeks	Hamilton Depression Rating Scale (HAM-D)
Blood samples	24-26 weeks	Low Density Lipoproteins (LDP)
Self-report sedentary behaviour and physical activity	24-26 weeks	International Physical Activity Questionnaire (IPAQ)