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

Primary Purpose

Severe Mental Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Mental Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PAI

    TAU

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Anthropometric measures
    Body Max Index (BMI), in kg/m^2
    Anthropometric measures
    height in centimeters
    Anthropometric measures
    abdominal circumference in centimeters
    Anthropometric measures
    weight in kilograms
    Self-report sedentary behaviour and physical activity
    International Physical Activity Questionnaire (IPAQ)
    Cardiorespiratory Fitness
    6MWT
    Sleep behavior
    Pittsburgh sleep quality index (PSQI)
    Quality of life (QoL)
    The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
    Motivation to engage in physical activity
    Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
    Psychiatric symptoms
    brief psychiatric rating scale (BPRS)
    Psychiatric symptoms
    Hamilton Depression Rating Scale (HAM-D)
    Blood samples
    HIgh Density Lipoproteins (HDL)
    Blood samples
    blood glucose levels
    Blood samples
    insulin levels
    Blood samples
    triglycerides
    Blood samples
    C-reactive Protein (CRP)
    Blood samples
    Low Density Lipoproteins (LDP)

    Full Information

    First Posted
    September 13, 2021
    Last Updated
    September 18, 2021
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05056181
    Brief Title
    "MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
    Official Title
    "MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Mental Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PAI
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    TAU
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Physical Activity
    Intervention Description
    Physical activity
    Primary Outcome Measure Information:
    Title
    Percentage of patients that will complete the study (Acceptability)
    Description
    to evaluate if participants can be recruited into the study and if they complete the intervention.
    Time Frame
    24-26 weeks
    Secondary Outcome Measure Information:
    Title
    Anthropometric measures
    Description
    Body Max Index (BMI), in kg/m^2
    Time Frame
    24-26 weeks
    Title
    Anthropometric measures
    Description
    height in centimeters
    Time Frame
    24-26 weeks
    Title
    Anthropometric measures
    Description
    abdominal circumference in centimeters
    Time Frame
    24-26 weeks
    Title
    Anthropometric measures
    Description
    weight in kilograms
    Time Frame
    24-26 weeks
    Title
    Self-report sedentary behaviour and physical activity
    Description
    International Physical Activity Questionnaire (IPAQ)
    Time Frame
    24-26 weeks
    Title
    Cardiorespiratory Fitness
    Description
    6MWT
    Time Frame
    24-26 weeks
    Title
    Sleep behavior
    Description
    Pittsburgh sleep quality index (PSQI)
    Time Frame
    24-26 weeks
    Title
    Quality of life (QoL)
    Description
    The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
    Time Frame
    24-26 weeks
    Title
    Motivation to engage in physical activity
    Description
    Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
    Time Frame
    24-26 weeks
    Title
    Psychiatric symptoms
    Description
    brief psychiatric rating scale (BPRS)
    Time Frame
    24-26 weeks
    Title
    Psychiatric symptoms
    Description
    Hamilton Depression Rating Scale (HAM-D)
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    HIgh Density Lipoproteins (HDL)
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    blood glucose levels
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    insulin levels
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    triglycerides
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    C-reactive Protein (CRP)
    Time Frame
    24-26 weeks
    Title
    Blood samples
    Description
    Low Density Lipoproteins (LDP)
    Time Frame
    24-26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: under the age of 18 not having a diagnosis of SMI be unable to do exercises be unable to give informed consent

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs