SchizophreniaPEPSYV@SINCT03261817
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
A study testing Physical activity (APA) and Health Education program (HE) in people with Schizophrenia and Physical Activity, run by University Hospital, Caen at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Physical Activity, Schizo Affective Disorder
- What is being tested?
- Physical activity (APA) and Health Education program (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2017to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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)
- Conditions
- Schizophrenia, Physical Activity, Schizo Affective Disorder
- Being tested
- Physical activity (APA), Health Education program (HE)
- Keywords
- web, brain imaging, heart rate variability, circadian cycles, cognition, well-being, hippocampus, N acetyl aspartate, white matter, physical activity
- Medical subject headings
- Schizophrenia, Motor Activity, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity (APA)Behavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| APA in patients | Experimental | patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week Receives: Behavioral: Physical activity (APA) |
| HE in patients | Sham comparator | patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week Receives: Behavioral: Health Education program (HE) |
| APA in healthy volunteer controls | Active comparator | Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week Receives: Behavioral: Physical activity (APA) |
| HE in healthy volunteer controls | Sham comparator | Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week Receives: Behavioral: Health Education program (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hippocampal volumes
The primary endpoint is the right and left hippocampal volumes
Measured: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Secondary outcomes (5)
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
Measured: 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)
Measured: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Circadian rhythms
temperature, actimetry and wake-sleep cycle
Measured: 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
Measured: 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
Measured: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start29 Sep 2017
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Why it stopped: No financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier du Rouvray
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261817
- Sponsor's protocol ID
- 2016-A00930-51
- Acronym
- PEPSYV@SI
- Status last verified
- Jul 2021
- First submitted
- 16 Aug 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38740618Trehout 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.
PubMed 32458107
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03261817
- Acronym / sponsor ID
- PEPSYV@SI / 2016-A00930-51
- Conditions
- Schizophrenia, Physical Activity, Schizo Affective Disorder
- Keywords
- web, brain imaging, heart rate variability, circadian cycles, cognition, well-being, hippocampus, N acetyl aspartate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No financial support
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Hospitalier du Rouvray
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| APA in patients | Experimental | Behavioral: Physical activity (APA)patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week |
| HE in patients | Sham comparator | Behavioral: Health Education program (HE)patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week |
| APA in healthy volunteer controls | Active comparator | Behavioral: Physical activity (APA)Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week |
| HE in healthy volunteer controls | Sham comparator | Behavioral: Health Education program (HE)Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | APA in healthy volunteer controls, APA in patients |
| 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 | Behavioural | HE in healthy volunteer controls, HE in patients |
Primary outcome
hippocampal volumes
Time frame: 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
5 secondary outcomes
Cerebral variables
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Physiological variables
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Circadian rhythms
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Clinical status
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Biological variables
Time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Results and safety
The study was stopped early (reason given: No financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 38740618Leroux 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.
- Derived from this study: PubMed 32458107Trehout 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity (APA) and Health Education program (HE) in people with Schizophrenia and Physical Activity, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hippocampal volumes (time frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.