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

University of Roma La Sapienza

Status: Not yet enrolling

Conditions: Severe Mental Disorder

Treatments: Other: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05056181

872/CE Lazio 1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

PAI

Experimental group

Description:

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.

Treatment:

Other: Physical Activity

TAU

No Intervention group

Description:

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.