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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00700-49 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Jean Monnet University | OTHER |
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Physical activity appears to be a novel and original adjunctive therapeutic approach in the management of patients with schizophrenia. It may help reduce schizophrenic symptoms, act as a pro-cognitive therapy, improve quality of life, and reduce cardiovascular comorbidities. Moreover, some evidence suggests that physical activity practiced in a natural environment has even more positive effects on mental health compared to physical activity carried out indoors or in urban settings. Indeed, greater exposure to greenery is associated with a better perception of general health and with reduced levels of cortisol, anxiety, and depression. No study has yet attempted to examine the impact of physical activity in green (outdoor) spaces compared to indoor physical activity on the negative symptoms of patients suffering from schizophrenia. The aim of this study is therefore to test this hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INT group | Experimental | 8-week indoor physical activity program (in a gymnasium) |
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| EXT group | Experimental | 8-week outdoor physical activity program |
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| TEM group | No Intervention | Without physical activiy program (no change in routine) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8-week outdoor physical activity program | Other | EXT group will perform aerobic and resistance exercises with a coach in adapted physical activities on a green environment in a parc. Sessions will be typically composed as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Self-evaluation of negative symptoms (SNS) questionnaire | The primary outcome will be the evolution of negative symtoms, assessed using the Self-evaluation of negative symptoms (SNS) questionnaire. The total SNS score ranges from 0 to 40, where higher scores indicate greater severity of negative symptoms. | Weeks 2, 10 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical global Impression (CGI) scale | The patient's overall symptomatology and functioning will be assessed by the Clinical global Impression (CGI) scale. The CGI scale is assessed on a 7-point scale, with the severity of illness rated from 1 (normal) to 7 (very seriously ill). CGI scores range from 1 (much improved) to 7 (much worse). | Weeks 2, 10 and 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medhi HOUSNI, Md | Contact | (0)477127885 | +33 | Mehdi.Housni@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Medhi HOUSNI, Md | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | France | 42055 | France |
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| 8-week indoor physical activity program | Other | INT group will perform aerobic and resistance exercises with a coach in adapted physical activities, inside a conventional gym. Sessions will be typically composed as follows:
|
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| Personal and social performance (PSP) scale | The patient's overall symptomatology and functioning will be assessed by the Personal and social performance (PSP) scale. Higher scores indicate higher levels of perceived stress. | Weeks 2, 10 and 22 |
| Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) | Cognitive disorders reported will be assessed using the French version of the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS). The total score (range 0-84) is calculated as the sum of all items, with higher scores reflecting a greater Self-Appraisals of Cognitive Deficits. | Weeks 2, 10 and 22. |
| VO2 max | VO2 max will be estimated on the basis of heart rate measured during a submaximal test on an ergonomic bicycle. | Weeks 2, 10 and 22. |
| Maximum force | The maximum force produced by the knee extensors will be measured on a dynamometer. | Weeks 2, 10 and 22. |
| Flexibility | Flexibility of the posterior chain will be measured with the sit and reach test. | Weeks 2, 10 and 22. |
| Spatio-temporal coordination | Spatio-temporal coordination will be assessed by measuring individual reaction times. | Weeks 2, 10 and 22. |
| Balance | Balance will be tested by stabilometry on a Winposturo force platform. | Weeks 2, 10 and 22. |
| IPAQ questionnaire | The level of sedentariness will be measured by the IPAQ questionnaire. This questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | Weeks 2, 10 and 22. |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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