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

NCT05056181 | Unknown

• 1 other identifier: 872/CE Lazio 1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Anthropometric measures

  24-26 weeks

• Anthropometric measures

  24-26 weeks

• Anthropometric measures

  24-26 weeks

• Anthropometric measures

  24-26 weeks

• Self-report sedentary behaviour and physical activity

  24-26 weeks

Study Arms (2)

PAI

EXPERIMENTAL

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

TAU

NO INTERVENTION

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.

Interventions

Physical Activity OTHER

Physical activity

PAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of any SMI
• Meeting any one of the following criteria as determined by a care co-ordinator:
• Overweight
• At risk for or have type 2 diabetes mellitus
• In the clinician's view, have a sedentary lifestyle
• Smoke tobacco
• Ability to provide informed consent
• Ability to understand Italian

You may not qualify if:

• under the age of 18
• not having a diagnosis of SMI
• be unable to do exercises
• be unable to give informed consent

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 24, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: July 1, 2024
• Last Updated: September 24, 2021

Record last verified: 2021-09