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

NCT ID: NCT03261817

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2021-06-22

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:

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)

Conditions

Schizophrenia; Physical Activity; Schizo Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

APA in patients

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

Group Type: EXPERIMENTAL

Physical activity (APA)

Intervention Type: BEHAVIORAL

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

HE in patients

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

Group Type: SHAM_COMPARATOR

Health Education program (HE)

Intervention Type: BEHAVIORAL

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

APA in healthy volunteer controls

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

Group Type: ACTIVE_COMPARATOR

Physical activity (APA)

Intervention Type: BEHAVIORAL

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

HE in healthy volunteer controls

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

Group Type: SHAM_COMPARATOR

Health Education program (HE)

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier du Rouvray

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caen University Hospital

Caen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38740618 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32458107 (View on PubMed)

Other Identifiers

2016-A00930-51

Identifier Type: -

Identifier Source: org_study_id