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

Sponsor

University Hospital, Caen (Other)

Overall Status

Terminated

CT.gov ID

NCT03261817

Collaborator

Centre Hospitalier du Rouvray (Other)

Enrollment

Location

Arms

44.7

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Physical Activity Schizo Affective Disorder	Behavioral: Physical activity (APA) Behavioral: Health Education program (HE)	N/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 hippocampus.

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

HV:

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
on physiological variables (neuromuscular, cardiovascular (heart rate variability) and aerobic)
on cognitive variables by measuring working memory, episodic memory, attentional and executive functions
on circadian rhythms (temperature, actimetry and wake-sleep cycle)
on the clinical status of patients (severity of symptoms, quality of life, level of activity and physical abilities).
on biological variables (fasting glucose, triglycerides, total cholesterol, High-density lipoprotein cholesterol (HDLc), Low-density lipoprotein cholesterol (LDLc)

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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: interventional (adapted physical activity APA) control (health education program)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:interventional (adapted physical activity APA) control (health education program)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Clinical and Brain Effects of Remote Web-based Adapted Physical Activity (e-APA) in Patients With Psychotic Disorders and Healthy Subjects: A Controlled, Multicenter Study

Actual Study Start Date :

Sep 29, 2017

Actual Primary Completion Date :

Jun 22, 2021

Actual Study Completion Date :

Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: APA in patients patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week	Behavioral: Physical activity (APA) 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
Sham Comparator: HE in patients patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week	Behavioral: Health Education program (HE) 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
Active Comparator: APA in healthy volunteer controls Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week	Behavioral: Physical activity (APA) 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
Sham Comparator: HE in healthy volunteer controls Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week	Behavioral: Health Education program (HE) 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

Outcome Measures

Primary Outcome Measures

hippocampal volumes [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
The primary endpoint is the right and left hippocampal volumes

Secondary Outcome Measures

Cerebral variables [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
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
Physiological variables [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2)
Circadian rhythms [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
temperature, actimetry and wake-sleep cycle
Clinical status [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
severity of symptoms, quality of life, level of activity and physical abilities
Biological variables [at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment]
fasting glucose, triglycerides, total cholesterol, HDLc, LDLc

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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