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

Schizophrenia Clinical Trial

— PEPSYV@SI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03261817
• Other study ID #: 2016-A00930-51
• Status: Terminated
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: June 22, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mood Disorders
• Physical Activity
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

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
• 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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre Hospitalier du Rouvray

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	Circadian rhythms	temperature, actimetry and wake-sleep cycle	at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Secondary	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
Secondary	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