Status:
TERMINATED
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Centre Hospitalier du Rouvray
Conditions:
Schizophrenia
Physical Activity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 A...
Detailed Description
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 hippo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03261817
Start Date
September 29 2017
End Date
June 22 2021
Last Update
March 22 2022
Active Locations (1)
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1
Caen University Hospital
Caen, France, 14033