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

NCT ID: NCT05056181

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-07-31

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.

Conditions

Severe Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: OTHER

Physical activity

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity

Physical activity

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Paolo Flocco

adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

872/CE Lazio 1

Identifier Type: -

Identifier Source: org_study_id