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

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ClinicalTrials.gov Identifier: NCT03261817
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Centre Hospitalier du Rouvray
Information provided by (Responsible Party):
University Hospital, Caen

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

Condition or disease Intervention/treatment Phase
Schizophrenia Physical Activity Schizo Affective Disorder Behavioral: Physical activity (APA) Behavioral: Health Education program (HE) Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cerebral variables [ Time Frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment ]
    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

  2. Physiological variables [ Time Frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment ]
    neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2)

  3. Circadian rhythms [ Time Frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment ]
    temperature, actimetry and wake-sleep cycle

  4. Clinical status [ Time Frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment ]
    severity of symptoms, quality of life, level of activity and physical abilities

  5. Biological variables [ Time Frame: at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment ]
    fasting glucose, triglycerides, total cholesterol, HDLc, LDLc



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261817


Contacts
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Contact: Sonia Dollfus, Prof +33231065018 dollfus-s@chu-caen.fr
Contact: Cathy Gaillard, MD gaillard-c@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France, 14033
Contact: Sonia Dollfus, MD, PhD    + 33 2 31 06 5018    dollfus-s@chu-caen.fr   
Principal Investigator: Sonia Dollfus, MD, PhD         
Sponsors and Collaborators
University Hospital, Caen
Centre Hospitalier du Rouvray

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03261817     History of Changes
Other Study ID Numbers: 2016-A00930-51
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Caen:
web
brain imaging
heart rate variability
circadian cycles
cognition
well-being
hippocampus
N acetyl aspartate
white matter
physical activity

Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders