Not provided
Not provided
Not provided
Not provided
No financial support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Hospitalier du Rouvray | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
In this study, an APA program by web (e-APA) will be offered to two groups of participants (21 patients and 21 healthy volunteers (HV)) in remote video (use of the SAPATIC (Santé Activités Physiques Adaptées utilisant les Technologies de l'Information et de la Communication) platform developed by the company V@SI). At the same time, two control groups, a group of 21 patients and a group of 21 HV will undergo an health education program (HE) through the collaborative SAPATIC health platform of V@Si and will constitute the control groups. The content of the APA sessions will be administered by V@Si. This program offers content aimed to improve aerobic capacity and muscular strength while relying on the motivation of the participants
The main objective is to demonstrate that APA can improve cerebral plasticity in patients with schizophrenic or schizoaffective disorders (SCZ), reflected by an increase in the overall volume of hippocampus.
The secondary objectives will also be to assess the impact of APA on the SCZ compared to the HV:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APA in patients | Experimental | patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week |
|
| HE in patients | Sham Comparator | patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week |
|
| APA in healthy volunteer controls | Active Comparator | Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week |
|
| HE in healthy volunteer controls | Sham Comparator | Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity (APA) | Behavioral | 2 sessions a week of 1 hour during 16 weeks. APA exercises by web will be aerobic type associated with muscle toning program; Activities will combine relaxation techniques, body expression and muscle relaxation (yoga, stretching, relaxation, step etc ...). The intensity of the activities will be individualized for each participant according to his/her physical condition |
| Measure | Description | Time Frame |
|---|---|---|
| hippocampal volumes | The primary endpoint is the right and left hippocampal volumes | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral variables | changes in the different subregions of the hippocampus (CA1, CA2-3-4, subiculum and dentate gyrus, cortical thickness, N-acetyl aspartate (NAA) and glutamate as well as changes in the white matter through the diffusion markers (fractional anisotropy, radial diffusivity and mean diffusivity in the frontomedial-hippocampal fibers) and cerebral irrigation | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
Not provided
Inclusion Criteria:
Patients:
Healthy Volunteers:
Exclusion Criteria:
Patients with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
Healthy Volunteers
Participants with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38740618 | Derived | Leroux E, Trehout M, Reboursiere E, de Flores R, Morello R, Guillin O, Quarck G, Dollfus S. Effects of web-based adapted physical activity on hippocampal plasticity, cardiorespiratory fitness, symptoms, and cardiometabolic markers in patients with schizophrenia: a randomized, controlled study. Eur Arch Psychiatry Clin Neurosci. 2024 Sep;274(6):1245-1263. doi: 10.1007/s00406-024-01818-8. Epub 2024 May 13. | |
| 32458107 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009043 | Motor Activity |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D043384 | Glutamyl Aminopeptidase |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Randomization will be centralized and will be established for SCZ; Healthy Controls (HV) will be recruited by being matched to patients on age (according to 4 categories (18-25 years, 25-35 years, 35-50 years and> 50 years), gender and level of activity estimated by the self-administered questionnaire of Ricci and Gagnon.
Randomization will be carried out in two arms:
Not provided
Not provided
Not provided
Not provided
|
| Health Education program (HE) | Behavioral | 2 sessions a week of 1 hour during 16 weeks HE by web will be delivered and was composed of information on the main mental disorders, the benefits of physical activity, healthy lifestyle (dietary balance, sleep cycle, stress management), alcohol, drug, tobacco and cardiovascular risk factors |
|
| Physiological variables | neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2) | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
| Circadian rhythms | temperature, actimetry and wake-sleep cycle | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
| Clinical status | severity of symptoms, quality of life, level of activity and physical abilities | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
| Biological variables | fasting glucose, triglycerides, total cholesterol, HDLc, LDLc | at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment |
| Derived |
| Trehout M, Leroux E, Bigot L, Jego S, Leconte P, Reboursiere E, Morello R, Chapon PA, Herbinet A, Quarck G, Dollfus S. A web-based adapted physical activity program (e-APA) versus health education program (e-HE) in patients with schizophrenia and healthy volunteers: study protocol for a randomized controlled trial (PEPSY V@Si). Eur Arch Psychiatry Clin Neurosci. 2021 Mar;271(2):325-337. doi: 10.1007/s00406-020-01140-z. Epub 2020 May 26. |
| D000626 | Aminopeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |