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

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

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

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Physical Activity; Schizo Affective Disorder
• Intervention / Treatment: Behavioral: Physical activity (APA); Behavioral: Health Education program (HE)

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:

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)

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Circadian rhythms	temperature, actimetry and wake-sleep cycle	at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Centre Hospitalier du Rouvray

Publications and helpful links

General Publications

• Trehout M, Leroux E, Bigot L, Jego S, Leconte P, Reboursiere E, Morello R, Chapon PA, Herbinet A, Quarck G, Dollfus S. A web-based adapted physical activity program (e-APA) versus health education program (e-HE) in patients with schizophrenia and healthy volunteers: study protocol for a randomized controlled trial (PEPSY V@Si). Eur Arch Psychiatry Clin Neurosci. 2021 Mar;271(2):325-337. doi: 10.1007/s00406-020-01140-z. Epub 2020 May 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; cognition; well-being; heart rate variability; white matter; web; brain imaging; circadian cycles; hippocampus; N acetyl aspartate
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders
• Other Study ID Numbers: 2016-A00930-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No