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

Primary Purpose

Schizophrenia, Physical Activity, Schizo Affective Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity (APA)
Health Education program (HE)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring web, brain imaging, heart rate variability, circadian cycles, cognition, well-being, hippocampus, N acetyl aspartate, white matter, physical activity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

APA in patients

HE in patients

APA in healthy volunteer controls

HE in healthy volunteer controls

Arm Description

patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week

patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week

Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week

Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week

Outcomes

Primary Outcome Measures

hippocampal volumes
The primary endpoint is the right and left hippocampal volumes

Secondary Outcome Measures

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
Physiological variables
neuromuscular, cardiovascular (heart rate variability) and aerobic (VO2)
Circadian rhythms
temperature, actimetry and wake-sleep cycle
Clinical status
severity of symptoms, quality of life, level of activity and physical abilities
Biological variables
fasting glucose, triglycerides, total cholesterol, HDLc, LDLc

Full Information

First Posted
August 16, 2017
Last Updated
March 8, 2022
Sponsor
University Hospital, Caen
Collaborators
Centre Hospitalier du Rouvray
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1. Study Identification

Unique Protocol Identification Number
NCT03261817
Brief Title
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
Acronym
PEPSYV@SI
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
No financial support
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Centre Hospitalier du Rouvray

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Physical Activity, Schizo Affective Disorder
Keywords
web, brain imaging, heart rate variability, circadian cycles, cognition, well-being, hippocampus, N acetyl aspartate, white matter, physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APA in patients
Arm Type
Experimental
Arm Description
patients receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
Arm Title
HE in patients
Arm Type
Sham Comparator
Arm Description
patients receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
Arm Title
APA in healthy volunteer controls
Arm Type
Active Comparator
Arm Description
Healthy volunteers receiving physical activity (APA) by web during 16 weeks with 2 sessions a week
Arm Title
HE in healthy volunteer controls
Arm Type
Sham Comparator
Arm Description
Healthy volunteers receiving Health education program (HE) by web during 16 weeks with 2 sessions a week
Intervention Type
Behavioral
Intervention Name(s)
Physical activity (APA)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health Education program (HE)
Intervention Description
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 Measure Information:
Title
hippocampal volumes
Description
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
Secondary Outcome Measure Information:
Title
Cerebral variables
Description
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
Title
Physiological variables
Description
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
Title
Circadian rhythms
Description
temperature, actimetry and wake-sleep cycle
Time Frame
at Day 127 +/- 8 days or after 10 sessions of APA if premature cessation of treatment
Title
Clinical status
Description
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
Title
Biological variables
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32458107
Citation
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.
Results Reference
derived

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

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