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

NCT05056181 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-24

No results posted yet for this study

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

Interventions

OTHER

Physical Activity

Physical activity

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-09-30
Completion
2024-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056181 on ClinicalTrials.gov