Study Stopped
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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
1 other identifier
interventional
62
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Sep 2017
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedMarch 22, 2022
July 1, 2021
3.7 years
August 16, 2017
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Cerebral variables
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Physiological variables
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Circadian rhythms
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Clinical status
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Biological variables
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Study Arms (4)
APA in patients
EXPERIMENTALpatients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
HE in patients
SHAM COMPARATORpatients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
APA in healthy volunteer controls
ACTIVE COMPARATORHealthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
HE in healthy volunteer controls
SHAM COMPARATORHealthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- Age under 18 or over 60 years old
- Pregnancy
- 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
- Age under 18 or over 60 years old
- Pregnancy
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- Centre Hospitalier du Rouvraycollaborator
Study Sites (1)
Caen University Hospital
Caen, 14033, France
Related Publications (2)
Leroux E, Trehout M, Reboursiere E, de Flores R, Morello R, Guillin O, Quarck G, Dollfus S. Effects of web-based adapted physical activity on hippocampal plasticity, cardiorespiratory fitness, symptoms, and cardiometabolic markers in patients with schizophrenia: a randomized, controlled study. Eur Arch Psychiatry Clin Neurosci. 2024 Sep;274(6):1245-1263. doi: 10.1007/s00406-024-01818-8. Epub 2024 May 13.
PMID: 38740618DERIVEDTrehout 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.
PMID: 32458107DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 25, 2017
Study Start
September 29, 2017
Primary Completion
June 22, 2021
Study Completion
June 22, 2021
Last Updated
March 22, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share