Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Episode of Psychosis (DYNAMO-PSY)

Adapted Physical Activity Program in a Enriched Environment and Virtual Reality - Connected Bike - for Patients Undergoing Antipsychotic Treatment in the Context of a First Episode of Psychosis

The purpose of this PILOT feasibility study is to verify the acceptability, feasibility, and compliance to the DYNAMO-PSY program among young adults treated with antipsychotics for a first episode of psychosis (FEP).

Our hypothesis is that the use of an immersive program of APA, including an EE with VR (connected bikes), will allow good observance to regular physical activity in patients treated with antipsychotics for a FEP. This regular practice of physical activity will prevent the onset of weight gain and metabolic syndrome. In addition, a positive effect on self-esteem, overall and particularly cognitive functioning, quality of life, and adherence to antipsychotic treatment can be expected."

Study Overview

• Status: Not yet recruiting
• Conditions: Schizo Affective Disorder; Schizophrenia; Psychosis; First Episode Psychosis (FEP)
• Intervention / Treatment: Other: Adapted physical activity program involving connected bikes

Detailed Description

Introduction :

Patients suffering from schizophrenia (SCZ) (1% of the general French population) have an increased risk of cardio-metabolic morbidity and mortality, and their life expectancy is reduced by 15 years. In France, the incidence of psychotic disorders is estimated at 15,000 new cases per year among young people aged 15 to 25 years. Psychotic disorders have a significant socio-economic impact, and the emergence of these disorders represents a real break at the individual, social, and family levels. The first clinical signs of the FEP appear in adolescence or early adulthood, particularly because the brain is more vulnerable during this period to environmental risk factors such as substance use and stress.

Early intervention propose appropriate care from the first symptoms, including the introduction of antipsychotic treatment. However, we know that these treatments can lead to weight gain and metabolic syndrome, a risk factor for cardiovascular disease that can generate treatment discontinuation. Moreover, we know that neurocognitive disorders are predisposing factors not only for the development of early psychosis but also for the chronicity of a psychotic pathology.

Alternative approaches have been developed over the past decades to manage daily difficulties of patients with a FEP (e.g., cognitive issues, symptoms, metabolic syndrome), like a lack of physical activity. Indeed, the relationship between physical exercise and functional improvement has catched the attention of the scientific community, which is testing different approaches in healthy subjects and patients with psychotic disorders. The benefits of physical activity are described in patients with SCZ on weight, metabolic syndrome, and cardiovascular risk ; however, physical activity is too little invested in or quickly abandoned. Adapted physical activity (APA) is particularly indicated in psychiatry, and the benefits of APA in patients with SCZ is proven.

The enriched environment (EE) consists of a set of behavioral interventions to maximize stimulations, which can rely on Virtual Reality (VR) technologies. An immersive, realistic, and attractive environment will increase motivation and observance. Furthermore, the training is safer and more controlled than in outdoor conditions. A research combining EE and VR has used stationary bikes connected to a screen to maintain the physical, cognitive, and social capabilities of elderly subjects. To our knowledge, there are no studies using an EE with VR for the practice of APA in patients suffering from a FEP. However, this EE could lead, with its playful and immersive aspect, to a better observance to APA.

An adapted physical activity program usig connected bike with enriched environment (DYNAMO-PSYProgram) could help to prevent weight gain et metabolic syndrome in a population of First Episode Psychosis patients treated with antipsychotic drugs.

This study is a prospective, monocentric PILOT study. The main objective will be to check that at least 70% of the patients can complete the 20 sessions of the program.

Methods

The treatment being studied involves a program (DYNAMO-PSY) of adapted physical activity with an enriched environment (connected bike, visualized and experienced roads in virtual reality) and supervised, with (on average) two sessions per week, a total of 20 sessions to be completed over a maximum of 15 weeks. The usual hygienic-dietetic care is not modified by the study and consists of the care proposed to patients of the GHU Paris Psychiatry and Neuroscience who have had a first psychotic episode and are treated primarily with medication: clinical and biological monitoring

The visits planned by the experimental protocol include:

• a pre-inclusion visit V0, where oral and written information about the study is given to the patient by one of the study investigators
• an inclusion visit = V1 (at least 48 hours after V0, and no more than 15 days later, so that the patient has time to consider participating in the study), with the signing of the informed consent form in the presence of a study investigator.
• an end-of-study visit (= V2), 15 weeks after the inclusion visit V1.

The following elements will be collected for all patients at V1 :

• age, sex at birth, gender
• patients sports habits (weekly physical activity duration, type of physical activity), presence or absence of a dietary follow-up, current psychotropic medication, substance use will also be collected.

The following elements will be collected for all patients at V1 and V2 :

• psychiatric symptomes, with CAARMS, PANSS, HAD-A, HAD-D, SNS, STAI A / B.
• self-esteem measured by Rosenberg self-esteem scale (RSES)
• functional impact with the WHO-QOL-BREF (World Health Organization-Quality Of Life) quality of life questionnaire, the SOFAS, and the general functioning score on the Global Assessment of Functioning (GAF) scale
• cognitive tests : Memory with scores at California Verbal Learning Test (CVLT), digit span, Corsi Block, MEM-III, Executive functions with Trail Making Test (TMT), verbal fluencies, Stroop test, 'test des comissions', autoquestionnaire Behavior Rating Inventory of Executive Function (BRIEF) Processing speed with scores at Coding Test and Symbol search. Attention with score at Symbol Searchn coding D2R task.
• adherence to antipsychotic treatment with the MARS (Medication Adherence Rating Scale) questionnaire.

The following cardiometabolic parameters will be recorded at V1 and V2:

• weight (in kg, assessed with a bioimpedance scale)
• body mass index (weight / height^2)
• waist circumference (in cm, measured with a tape measure)
• fasting blood glucose concentration (in mmol/l)
• blood triglyceride levels (mmol/l)
• cholesterol levels (total, HDL, LDL)
• systolic and diastolic blood pressure (in mmHg)

Outcomes :

Primary Outcome is to calculate the proportion of patients who fully complete the DYNAMO-PSY program.

It will be measured by the Completion rate : ie. the number of patients who fully complete the DYNAMO-PSY program.

The completition rate to the DYNAMO-PSY program is calculated as the proportion: number of patients who completed the program / number of patients included in the study.

Secondary Outcomes :

1. Explore the acceptability and compliance to the DYNAMOPSY program, which will be evaluated with :

   • Acceptability rate (number of patients accepting the program / number of eligible patients)
   • compliance rate (number of sessions completed / number of planned sessions).
   • The mean duration of the program.
2. Explore effect of DYNAMOPSY program on psychiatric symptomes (scores at CAARMS, PANSS, HAD-A, HAD-D, and SNS), cognition (memory with scores at CVLT, number memory, corsi task, executive functions with TMT, fluencies, stroop test, 'test des comissions', BRIEF, attention with score at D2R), general status (self-esteem with WHO-QOL-BREF, quality of life with SOFAS, level of functioning scores with GAF), adhesion to antipsychotic treatment (MARS Scale) between V1 and V2.
3. Explore the effect of DYNAMOPSY program on cardiometabolic parameters (weight, body mass index, waist circumference, fasting blood glucose concentration, blood triglyceride levels, cholesterol levels, systolic and diastolic levels (HDL, LDL, total), systolic and diastolic blood presure.
4. Explore the influence of age, sex, sports habits, presence of a dietary follow up, current psychotropic medication, substance use on completing the program.

Statistics :

Statistical analysis will be performed

Sample size :

The sample size was estimated using the confidence interval approach for a proportion (Clopper-Pearson exact test). It is considered that the minimum compliance rate (patients who complete the program/adherent patients) for planning the main study should be at least 70%. Therefore, given the pilot nature of the study, the confidence level (1-alpha) is set at 80% and a bilateral confidence interval equal to 0.18 (CI=0.70-0.88), a necessary sample size of 40 subjects was estimated.

All continuous variables, including changes from baseline, will be summarized with the following statistics:

• Mean
• Standard deviation
• 95% confidence interval
• Median
• Interquartile range (IQR) for asymmetric variables Missing values will be indicated.

The following formulas will be used, depending on how the post-baseline endpoint is defined, for each planned visit and for each time point where both baseline and post-baseline values are available:

• Change from baseline = post-baseline value - baseline value
• Percentage change from baseline = (post-baseline value - baseline value) / baseline value * 100%
• Ratio to baseline = post-baseline value / baseline value

Baseline characteristics: An initial descriptive analysis will be performed for all collected variables, including :

• For all quantitative variables:

  • Absolute, relative, and cumulative frequency
  • 95% confidence interval
  • Interquartile range
  • Indication of missing values

• For all qualitative variables:

  • Absolute, relative, and cumulative frequency
  • 95% confidence interval
  • Indication of missing values

For the evaluation of the primary objective, the percentage of patients who completed the DYNAMO-PSY program according to the protocol will be calculated based on the specified criteria in the primary objective:

• The DYNAMO-PSY program is considered completed when the patient has completed all 20 sessions for a duration of up to 15 weeks.

The hypothesis assumes a non-inferior completion rate of 70%. A 95% confidence interval around the percentage of patients who completed the program will be provided.

Secondary objectives:

1. For acceptance rate (number of patients accepting the program / number of eligible patients) and compliance rate (number of completed sessions / number of planned sessions), the percentage and 95% confidence interval will be provided.

2. Regarding the comparison of psychiatric symptoms, general status (self-esteem, quality of life, overall functioning), neurocognition, cardiometamolic parameters before and after the DYNAMO-PSY program, the following exploratory analyses will be conducted:

   • Quantitative data will be compared between completers and non-completers using Student's t-tests or ANOVA, or non-parametric tests (Wilcoxon, Mann-Whitney, Kruskal-Wallis) if the distribution remains asymmetric even after appropriate transformation (e.g., Tukey's power transformation scale).
   • Paired tests will be used for comparing repeated measurements within the same patients.
   • Qualitative data will be compared using Chi-squared tests or Fisher's exact tests for independent groups, and McNemar's tests for paired groups (repeated measurements).
3. The influence of age, sex, current psychotropic medication, substance use, dietery follow up, sport habbit on completing the program will be analyzed with chi square tests.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphaëlle LEROUX AUGER, DR; Phone Number: +33 145 652 130; Email: r.leroux_auger@ghu-paris.fr
• Study Contact Backup: Name: ALEXANDRA PHAM, DR; Phone Number: 01 45 65 83 70; Email: A.PHAM@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patient suffering or having suffered from a FEP, corresponding to the criteria of brief psychotic episode or schizoaffective disorder in the DSM-5, within the last two years.

Or suffering from schizophrenia or a schizoaffective disorder, evolving for less than two years.

• Aged 18 to 30 years.
• Male or female.
• inpatient or outpatient.
• Treated with antipsychotic (typical or atypical).
• Willing to participate in the study and having signed the informed consent form after oral and written information.
• Affiliated or beneficiary of a health insurance scheme.

Exclusion Criteria:

• Patient not fluent in French.
• Patient in detention or under protective measures.
• Patient hospitalized without consent
• Medical contraindication to cycling (notably ventricular arrhythmia, or prolonged QT interval), validated by a medical opinion.
• Known epilepsy.
• Pregnant or breastfeeding women.

Specific Contraindications to Virtual Reality:

• High susceptibility to motion sickness.
• Vestibular disorders.
• Anomalies in postural statics and/or dynamic balance with proprioception disorders.
• Uncorrected ocular or oculomotor disorders.
• Frequent migraines.
• Severe anxiety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DYNAMO-PSY program; This is a feasibility study. Therfore, there is only one arm, the experimental one, where participants will be enrolled in the DYNAMO-PSY program.

Other: Adapted physical activity program involving connected bikes; The treatment being studied involves a program (DYNAMO-PSY) of adapted physical activity with an enriched environment (connected bike, visualized and experienced routes in virtual reality) and is supervised, comprising (on average) two sessions per week, a total of 20 sessions to be completed over a maximum of 15 weeks. Each session will last 60 minutes and will be supervised by a case manager. They will be composed of a warm up, session on the bike (around 30 minutes of bicycling) and stretching. They will take place in an adequate room in the clinical research department of Saint Anne Hospital. The usual hygienic-dietetic care is not modified by the study and consists of the care proposed to patients of the GHU Paris Psychiatry and Neuroscience who have had a first psychotic episode and are treated primarily with medication: clinical and biological monitoring, dietary consultations, therapeutic education group concerning diet and lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of the DYNAMO-PSY program	The main objective will be to assess the completion rate of the dynamopsy program. Then, the primary outcome measure will be the completion of the program by the participant (Yes/No). For each patient included in the study, the number of sessions completed will be recorded. The DYNAMO-PSY program consists of 20 sessions in total. The DYNAMO-PSY program is considered completed when the patient has completed 20 sessions (otherwise, the program is considered abandoned). The completion rate to the DYNAMO-PSY program will be calculated as the proportion : number of patients who completed the program / number of patients included in the study.	From enrollment to the end of the program at 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social and Occupational Functioning	Total score at SOFAS (Social and Occupational Functioning Assessment Scale)	at enrollment and at 15 weeks
Global Functionning	Total score at Global Assessment of Functioning (GAF) scale	at enrollment and at 15 weeks
Executive functions - Inhibition	Score at Stroop Test	at the enrollment and at 15 weeks
Executive functions : Cognitive flexibility	Score at Trail Making Test	at the enrollment and at 15 weeks
Executive functions - symptoms inventory	Composite executive globale Score (CEG) at the BRIEF questionnaire ( Behavior Rating Inventory of Executive Function ). Questionnaire fulfilled by the patient himself.	at the enrollment and at 15 weeks
Memory : Digit Span	Total score at Digit Span task	at enrollment and at 15 weeks
Memory : visuospatial working memory	Total score at Corsi block - taping task	at enrollment and at 15 weeks
Memory : Episodic memory	Total Score at MEM III task	at enrollment and at 15 weeks
Memory : Processing speed (visual perception)	Total score at Symbol Search task	at enrollment and at 15 weeks
Attention	Total score at D2R task	at enrollment and at 15 weeks
Adherence to antipsychotic treatment	Total score at MARS (Medication Adherence Rating Scale) autoquestionnaire	at enrollment and at 15 weeks
Weight	Weight (in kg, assessed with a bioimpedance scale)	at enrollment and at 15 weeks
Body mass index	Calculated as : weight / height^2	at enrollment and at 15 weeks
waist circumference	in cm, measured with a tape measure	at enrollment and at 15 weeks
fasting blood glucose concentration	fasting blood glucose concentration (in mmol/l)	at enrollment and at 15 weeks
blood triglyceride levels	blood triglyceride levels (mmol/l)	at enrollment and at 15 weeks
Total cholesterol level	Total cholesterol blood level in mmol/L	at enrollment and at 15 weeks
HDL cholesterol level	HDL cholesterol blood level in mmol/L	at enrollment and at 15 weeks
LDL cholesterol level	LDL cholesterol blood level in mmol/L	at enrollment and at 15 weeks
Systolic blood pressure	Systolic blood pressure in mmHg	at enrollment and at 15 weeks
diastolic blood pressure	diastolic blood pressure in mmHg	at enrollment and at 15 weeks
Quality of life as assessed by WHO-QOL-BREF	Total Score at WHO-QOL-BREF (World Health Organization-Quality Of Life) questionnaire	at enrollment and at 15 weeks
Psychotic symptomes as measured with the PANSS	Psychotic symptomes measured with the PANSS (Positive and negative symptomes scale). We will measure three outcomes : Positive symptomes : total score at the positive symptomes subscale of the PANSS; Negative symptomes : total score at the positive symptomes subscale of the PANSS; General symptomes : total score at the general symptomes subscale of the PANSS	at the enrollment and at 15 weeks
Memory - Verbal Learning	Total score at California Verbal Learning Test (CVLT)	at enrollment and at 15 weeks
Executive functions Verbal fluencies	Total score at verbal fluencies task	at the enrollment and at 15 weeks
Acceptibility rate of the DYNAMO-PSY program	We will calculate the acceptibility rate as followed : Number of patients included / number of eligible patients	From enrollment to the end of the program at 20 weeks
Compliance of participants to the DYNAMO-PSY program	For each participants, we will measure how many sessions have been completed. The compliance rate will be measured as followed : Number of sessions completed by the participant / 20 (number of planned sessions)	From enrollment to the end of the program at 15 weeks
Negative psychotic symptoms as measured by SNS	Total score at self evaluation of negative symptoms scale (autoquestionnaire).	at enrollment and at 15 weeks
Memory : Number memory	Score at number memory task	at the enrollment and at 15 weeks
Executive functions : Planification	Score at the french test -test des comissions-	at the enrollment and at 15 weeks
Depression symptomes as measured with HAD-D	Score at the -depression- subscale of the HAD scale (autoquestionnaire)	at enrollment and at 15 weeks
Mean duration of the program	For each participants that completed the DYNAMO-PSY program, we will measure time (in days) between the first and the last session (ie the 20th) of the DYNAMOPSY program. We will calculate the mean duration of the program among participants that completed the program.	at the first and at the last session of the DYNAMO-PSY program
Anxiety symptoms as measured by HAD-A	Score at anxiety subscale of Hospital anxiety and depression scale (HAD-A) (autoquestionnaire)	at enrollment and at 15 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Raphaëlle LEROUX AUGER, DR, Pôle PEPIT - Centre d évaluation pour Jeunes Adultes et Adolescents (CJAAD)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Early Intervention; Adapted physical activity; Metabolic Syndrom; First Episode psychosis
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders
• Other Study ID Numbers: D23-P009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No