Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643871
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-16
Brief Title:
Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Episode of Psychosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMO-PSY
Brief Summary:
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 expectedampampampampampampampampamp34
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 expectedampampampampampampampampamp34
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 15000 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 eg 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 height2
waist circumference in cm measured with a tape measure
fasting blood glucose concentration in mmoll
blood triglyceride levels mmoll
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 programadherent 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 018 CI070-088 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 Students t-tests or ANOVA or non-parametric tests Wilcoxon Mann-Whitney Kruskal-Wallis if the distribution remains asymmetric even after appropriate transformation eg Tukeys 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 Fishers exact tests for independent groups and McNemars 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
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 15000 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 eg 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 height2
waist circumference in cm measured with a tape measure
fasting blood glucose concentration in mmoll
blood triglyceride levels mmoll
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 programadherent 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 018 CI070-088 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 Students t-tests or ANOVA or non-parametric tests Wilcoxon Mann-Whitney Kruskal-Wallis if the distribution remains asymmetric even after appropriate transformation eg Tukeys 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 Fishers exact tests for independent groups and McNemars 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None