Severe Mental DisorderNCT05056181
"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
A study testing Physical Activity in people with Severe Mental Disorder, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- under the age of 18
- not having a diagnosis of SMI
- be unable to do exercises
- be unable to give informed consent
About this study
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
- Being tested
- Physical Activity
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
Physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-26 weeks
Secondary outcomes (17)
Anthropometric measures
Body Max Index (BMI), in kg/m^2
Measured: 24-26 weeks
Anthropometric measures
height in centimeters
Measured: 24-26 weeks
Anthropometric measures
abdominal circumference in centimeters
Measured: 24-26 weeks
Anthropometric measures
weight in kilograms
Measured: 24-26 weeks
Self-report sedentary behaviour and physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: 24-26 weeks
Cardiorespiratory Fitness
6MWT
Measured: 24-26 weeks
Sleep behavior
Pittsburgh sleep quality index (PSQI)
Measured: 24-26 weeks
Quality of life (QoL)
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Measured: 24-26 weeks
Motivation to engage in physical activity
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Measured: 24-26 weeks
Psychiatric symptoms
brief psychiatric rating scale (BPRS)
Measured: 24-26 weeks
Psychiatric symptoms
Hamilton Depression Rating Scale (HAM-D)
Measured: 24-26 weeks
Blood samples
HIgh Density Lipoproteins (HDL)
Measured: 24-26 weeks
Blood samples
blood glucose levels
Measured: 24-26 weeks
Blood samples
insulin levels
Measured: 24-26 weeks
Blood samples
triglycerides
Measured: 24-26 weeks
Blood samples
C-reactive Protein (CRP)
Measured: 24-26 weeks
Blood samples
Low Density Lipoproteins (LDP)
Measured: 24-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Flocco, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056181
- Sponsor's protocol ID
- 872/CE Lazio 1
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
- ClinicalTrials.gov ID
- NCT05056181
- Acronym / sponsor ID
- 872/CE Lazio 1
- Conditions
- Severe Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAI | Experimental | Other: Physical ActivityParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of any SMI
- Meeting any one of the following criteria as determined by a care co-ordinator:
- Ability to provide informed consent
- Ability to understand Italian
Key exclusion criteria (4 listed)
- under the age of 18
- not having a diagnosis of SMI
- be unable to do exercises
- be unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical activity | Other | PAI |
Primary outcome
Percentage of patients that will complete the study (Acceptability)
Time frame: 24-26 weeks
to evaluate if participants can be recruited into the study and if they complete the intervention.
17 secondary outcomes
Anthropometric measures
Time frame: 24-26 weeks
Anthropometric measures
Time frame: 24-26 weeks
Anthropometric measures
Time frame: 24-26 weeks
Anthropometric measures
Time frame: 24-26 weeks
Self-report sedentary behaviour and physical activity
Time frame: 24-26 weeks
Cardiorespiratory Fitness
Time frame: 24-26 weeks
Sleep behavior
Time frame: 24-26 weeks
Quality of life (QoL)
Time frame: 24-26 weeks
Motivation to engage in physical activity
Time frame: 24-26 weeks
Psychiatric symptoms
Time frame: 24-26 weeks
Psychiatric symptoms
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Blood samples
Time frame: 24-26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Severe Mental Disorder, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that will complete the study (Acceptability) (time frame: 24-26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.