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
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:
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:
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
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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University Hospital, Caen