Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493955
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Evaluation of the Effectiveness of Extending the Passerelle System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine France
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Evaluation of the Effectiveness of Extending the Passerelle System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine France
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPA-NAQUI
Brief Summary:
Type 2 diabetes is on the increase worldwide Two major risk factors have been identified overweight and physical inactivity National and international recommendations encourage general practitioner to guide patients in changing their lifestyle As regards physical activity in France general practitioner have been able to prescribe adapted physical activity APA for their patients since 2016 In type 2 diabetes it is known that physical activity interventions are cost-effective However these interventions are often too expensive and far removed from real life It is also known that the benefits of intervention increase up to 18 months then diminish to zero at 36 months In Nouvelle-Aquitaine France the PEPS Sport-santé network offers physical activity coaching for patients who are not sufficiently active the Passerelle program Patients can benefit from a weekly physical activity session for 6 months
The investigators would therefore like to assess whether extending the existing Passerelle program by 6 months with one session every 15 days is effective in maintaining the volume of physical activity 12 months after the end of the intervention
The investigators would therefore like to assess whether extending the existing Passerelle program by 6 months with one session every 15 days is effective in maintaining the volume of physical activity 12 months after the end of the intervention
Detailed Description:
Over the last few decades we have witnessed an increasing rise in the prevalence of chronic diseases including type 2 diabetes T2DM Internationally diabetes affected 108 million people in the 1980s compared with 451 million in 2017 reaching epidemic proportions according to the World Health Organization WHO France has not been spared by T2DM with an estimated prevalence of 118 in 2017 and an incidence of 107 cases per 1000 person-years The chronic hyperglycemia of type 2 diabetes is associated with altered macronutrient metabolism with a lack of insulin secretion or reduced insulin sensitivity Insulin resistance impairs the ability of muscle cells to absorb and store glucose Two major modifiable risk factors have been identified overweight and physical inactivity T2DM increases the risk of myocardial infarction and stroke by a factor of 2 to 3 The ENTRED 3 study carried out in 2019 among diabetic patients in mainland France showed that 186 of type 2 diabetic patients had had a coronary complication and 78 a stroke In addition to these two macro-vascular complications diabetes is responsible for micro-vascular complications such as retinopathy and diabetic nephropathy The cost to society of physical inactivity is considerable Worldwide healthcare expenditure linked to T2DM and physical inactivity has been estimated at 376 billion dollars
The management of type 2 diabetic patients aims to reduce morbidity and mortality through glycemic control The latest French recommendations for the management of diabetic patients date from 2014 and encourage doctors to monitor their patients every three months to ensure compliance look for risk factors and comorbidities hypertension smoking and alcohol consumption measure blood pressure weight and calculate BMI HbA1c tests should be carried out between two and four times a year The first recommended hypoglycemic treatment is based on physical activity and diet
More recent recommendations from the American Diabetes Association ADA in 2022 encourage physicians to manage patients using a multifactorial approach First-line management involves lifestyle changes promoting healthier behaviors around diet physical activity promotion substance use such as smoking weight loss and sleep quality
Sport-health networks such as the PEPS network in the Nouvelle-Aquitaine region Prescription dExercice Physique pour la Santé - Prescription of Physical Exercise for Health make it easier for patients to be referred to a suitable structure for supervised exercise
Investigators would like to know whether extending this program with spaced sessions can encourage patients to change their behavior over the long term Spacing out the sessions should enable a smoother transition to independent or associative practice
The research question is as follows What is the effectiveness of a one-year Passerelle program in maintaining the volume of physical activity in T2DM patients in the Nouvelle-Aquitaine region
The management of type 2 diabetic patients aims to reduce morbidity and mortality through glycemic control The latest French recommendations for the management of diabetic patients date from 2014 and encourage doctors to monitor their patients every three months to ensure compliance look for risk factors and comorbidities hypertension smoking and alcohol consumption measure blood pressure weight and calculate BMI HbA1c tests should be carried out between two and four times a year The first recommended hypoglycemic treatment is based on physical activity and diet
More recent recommendations from the American Diabetes Association ADA in 2022 encourage physicians to manage patients using a multifactorial approach First-line management involves lifestyle changes promoting healthier behaviors around diet physical activity promotion substance use such as smoking weight loss and sleep quality
Sport-health networks such as the PEPS network in the Nouvelle-Aquitaine region Prescription dExercice Physique pour la Santé - Prescription of Physical Exercise for Health make it easier for patients to be referred to a suitable structure for supervised exercise
Investigators would like to know whether extending this program with spaced sessions can encourage patients to change their behavior over the long term Spacing out the sessions should enable a smoother transition to independent or associative practice
The research question is as follows What is the effectiveness of a one-year Passerelle program in maintaining the volume of physical activity in T2DM patients in the Nouvelle-Aquitaine region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None