An interventional study of Physical activity (APA) and Health Education program (HE) in Schizophrenia, Physical Activity and Schizo Affective Disorder, sponsored by University Hospital, Caen. Terminated at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Supportive care
Among 240 studies in Schizophrenia with a site in France — 54 open to participants now, 55 under way, 1 of them phase 3. Schizophrenia · France.
Among the 240 studies in Schizophrenia with a site in France, this one is the 142nd largest by enrollment of the 201 interventional ones that give a count, is one of 14 that started in 2017, is one of 144 with no phase, and was the 142nd registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
Browse Schizophrenia studies →54 of the 240 studies in Schizophrenia with a site in France are open now. Recruiting first, the newest first:
University Hospital, Toulouse · Sites in France
Centre Hospitalier St Anne · Sites in France
Centre Hospitalier Henri Laborit · Sites in France
Fondation FondaMental · Sites in France
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in France, United States, Australia and 8 more countries
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
240 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 13 · Phase 3 36 · Phase 4 8
First in 1983; this study’s year is marked. 14 started in 2017.
This study's enrollment of 62 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Median enrollment 110 across the 201 interventional studies, 92 across the 39 observational. Of the 149 that completed or were terminated, 31 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
58 of 240 have an industry lead sponsor. The 10 most frequent:
University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
University Hospital, Caen has 9 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
19 of the studies in Schizophrenia with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07316803Centre hospitalier de Ville-Evrard, FranceGroup Intervention for Romantic Relationships in Young Adults With Severe Mental Illness | 2026-11-30 |
| NCT05550155University Hospital, CaenEfficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations | 2026-12-30 |
| NCT06634446Centre Hospitalier St AnneSelf-administered COgnitive Personalized Training in Early Psychosis | 2026-12-30 |
| NCT05813457Centre Hospitalier Universitaire de Saint EtienneImpact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis | 2027-02 |
| NCT05349513Centre Hospitalier Henri LaboritInterest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders | 2027-02 |
Among the 240 studies in Schizophrenia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Healthy Volunteers:
Exclusion Criteria:
Patients with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
Healthy Volunteers
Participants with only one of the non-inclusion criteria may not be eligible to participate in the research. These criteria are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
Behavioral: Physical activity (APA)
patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
Behavioral: Health Education program (HE)
Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
Behavioral: Physical activity (APA)
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. 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
hippocampal volumes
The primary endpoint is the right and left hippocampal volumes
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
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
Time frame: 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)
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Circadian rhythms
temperature, actimetry and wake-sleep cycle
Time frame: 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
Time frame: 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
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Plan to share: No
Ran from Sep 2017 to primary completion in Jun 2021, 44 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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