A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders (PEPSYV@SI)

Caen University Hospital

Status: Terminated

Conditions: Physical Activity; Schizophrenia; Schizo Affective Disorder

Treatments: Behavioral: Physical activity (APA); Behavioral: Health Education program (HE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03261817

2016-A00930-51

Details and patient eligibility

About

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

Full 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 hippocampus.

The secondary objectives will also be to assess the impact of APA on the SCZ compared to the HV:

1. on other cerebral variables (changes in the different subregions of the hippocampus (Cornu Ammonis (CA: 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
2. on physiological variables (neuromuscular, cardiovascular (heart rate variability) and aerobic)
3. on cognitive variables by measuring working memory, episodic memory, attentional and executive functions
4. on circadian rhythms (temperature, actimetry and wake-sleep cycle)
5. on the clinical status of patients (severity of symptoms, quality of life, level of activity and physical abilities).
6. on biological variables (fasting glucose, triglycerides, total cholesterol, High-density lipoprotein cholesterol (HDLc), Low-density lipoprotein cholesterol (LDLc)

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups

APA in patients

Experimental group

Description:

patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week

Treatment:

Behavioral: Physical activity (APA)

HE in patients

Sham Comparator group

Description:

patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week

Treatment:

Behavioral: Health Education program (HE)

APA in healthy volunteer controls

Active Comparator group

Description:

Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week

Treatment:

Behavioral: Physical activity (APA)

HE in healthy volunteer controls

Sham Comparator group

Description:

Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week

Treatment:

Behavioral: Health Education program (HE)