A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders (PEPSYV@SI)
Schizophrenia, Physical Activity, Schizo Affective Disorder
About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring web, brain imaging, heart rate variability, circadian cycles, cognition, well-being, hippocampus, N acetyl aspartate, white matter, physical activity
Eligibility Criteria
Inclusion Criteria:
Patients:
- Be over 18 years of age and under 60 years of age
- with schizophrenia or schizoaffective disorder according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition) criteria established with a semi-structured interview (Mini International Neuropsychiatric Interview, French version 5.0.0).
- The possibility of receiving each of the 2 interventions (APA or HE)
- No change in psychotropic drugs (antidepressants, antipsychotics or mood regulators) during the 2 months prior to inclusion for patients.
- Collecting the signature of informed consent.
- The need to be affiliated to a medical welfare
- The agreement of the guardian or trustee in case of a protected major
Healthy Volunteers:
- between 18 and 60 years old
- The possibility of receiving each of the 2 interventions (APA or HE)
- Collecting the signature of informed consent.
- The need to be affiliated to a medical welfare
Exclusion Criteria:
Patients with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
- Age under 18 or over 60 years old
- Pregnancy
- The inclusion of the patient in another biomedical research protocol (during the present study)
- Patients with progressive neurological disease
- Patients with contraindications to MRI (including electronic or metal implants)
- Patients who refused to wear earplugs during the MRI examination
- Patients with a physical contraindication to physical activity (moderate to severe heart failure, severe valvular disease, unstable coronary disease, acute pulmonary embolism or untreated deep venous thrombosis, uncontrolled hypertension, pulmonary arterial hypertension, treaty)
- Neuromuscular pathologies, severe sensory and / or motor neuropathy
- Rheumatic and articular pathologies; Rheumatologic / orthopedic problems or bone lesions at risk of fracture contraindicating physical activity
- History of stroke or myocardial infarction less than 6 months old at the selection visit
Healthy Volunteers
Participants with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
- Age under 18 or over 60 years old
- Pregnancy
- Inclusion of the participant in another biomedical research protocol (during this study)
- Participants with progressive neurological disease
- Participants with a contraindication to MRI (including electronic or metal implants)
- Participants refused to wear ear plugs during the MRI examination
- Participants with life-long schizophrenia or schizoaffective disorder according to the DSM-IV criteria established with a semi-structured interview (Mini International Neuropsychiatric Interview, MINI; French version 5.0.0).
- Presence of cardiovascular pathologies contraindicating physical activity (moderate to severe heart failure, severe valvular disease, unstable coronary disease, acute pulmonary embolism or untreated deep venous thrombosis, uncontrolled hypertension, pulmonary arterial hypertension, rhythm disorder untreated)
- Neuromuscular pathologies, severe sensory and / or motor neuropathy
- Rheumatic and articular diseases, rheumatological / orthopedic problems or fracture risk bone lesions
- History of stroke or myocardial infarction less than 6 months old at the selection visit
Sites / Locations
- Caen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Active Comparator
Sham Comparator
APA in patients
HE in patients
APA in healthy volunteer controls
HE in healthy volunteer controls
patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week