FReSH-50257-draft-en
Impact of adapted physical activity on the quality of life of patients with type 2 diabetes
ACTI-DIAB
| Name | Country code |
|---|---|
| France | fr |
| Åland islands | ax |
This prospective observational study aims to evaluate the impact of a 12-week adapted physical activity program on the quality of life of adult patients with type 2 diabetes. Clinical and biological data, as well as quality of life scores (SF-36), are collected at baseline and at the end of the program in order to analyze changes in HbA1c, physical activity levels, and overall well-being among participants.
['Clinical data']
Individus
| Topic | Vocabulary |
|---|---|
| Addiction medicine | health theme |
| Infectious disease medicine | health theme |
| Diabetes mellitus, type unspecified | cim-11 |
| Type 2 diabetes mellitus | cim-11 |
| Environmental determinants | health determinant |
| Healthcare system determinants | health determinant |
['Grand Est','Nouvelle-Aquitaine']
{
"level_sex_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D005260"
},
"value": "Female"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008297"
},
"value": "Male"
}
],
"level_age_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000293"
},
"value": "Adolescent (13 to 18 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D055815"
},
"value": "Young Adult (19 to 24 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008875"
},
"value": "Middle Aged (45 to 64 years)"
}
],
"level_type_clusion_I": "General population",
"level_type_clusion_other": "",
"clusion_I": "Adults aged 18 to 70 years old Confirmed diagnosis of type 2 diabetes for at least 6 months\r\n\r\nHbA1c between 6.5% and 9.5% at inclusion Medical ability to perform appropriate physical activity Free, informed, and signed consent Affiliation with a social security system",
"clusion_E": "Type 1 diabetes or gestational diabetes Severe uncontrolled diabetes complications (cardiac, renal, neurological) Medical contraindication to physical activity Simultaneous participation in another interventional study\r\n\r\nPregnancy or breastfeeding Inability to understand the study information or comply with the protocol"
}
| Name |
|---|
| Saif;AGHAR |
| Name | Role |
|---|---|
| ARCELOR LUXEMBOURG | sponsor |
| Name |
|---|
| AG2R AGIRC-ARRCO (UGRR) |
| Name |
|---|
| Sarah;JONSHON |
| AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE) |
| Agency name |
|---|
| ANSM |
| Other |
['Through independent healthcare practitioners','Other']
['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}']
The aggregated, anonymized, and standardized data will be made available to academic partners and competent authorities via a secure platform or CSV/PDF files. Access is restricted to authorized users after authentication and confidentiality agreement, and reports are provided at the end of each analysis phase or upon request, in compliance with regulations.
Interventional Study
| Start | End |
|---|---|
| 2026-05-12 | 2026-08-30 |
monthly
| Standard |
|---|
| ['ICD-10: for coding pathologies and comorbidities.','LOINC: for the standardization of biological analyses and laboratory results.'] |
['Internal SOPs (Standard Operating Procedures) for the collection and entry of clinical and biological data.','Quality control and double entry into the secure database, with data verification and validation prior to analysis']
The data is stored securely in a centralized electronic database, hosted on servers that comply with security and confidentiality standards (GDPR). Physical and electronic access is strictly reserved for authorized members of the research team.
All data files are checked to ensure that all required variables are complete, that there are no duplicates, and that the records are consistent. Missing data is flagged and documented, and only complete and validated information is used for statistical analysis.
| Name | |
|---|---|
| Assistance;FRESH | assitanceIHdev@impactgroup.tech |
| Confidentiality declaration text |
|---|
| All users authorized to access data must sign a confidentiality agreement specifying their obligations regarding protection, non-disclosure, and compliance with regulations (GDPR, good clinical practices). This agreement governs the use, storage, and dissemination of data, ensuring the security and confidentiality of participants' information. |
Access to data is restricted to authorized investigators and personnel via secure login credentials. Any use of the data requires compliance with confidentiality protocols, the GDPR, and, where applicable, prior approval from the scientific committee or study sponsor.
OBLIIII
The results and analyses from the study must be sent to the sponsor and, where applicable, to the competent authorities in accordance with the deadlines set out in the protocol. Any external publication or dissemination requires the prior consent of the sponsor and compliance with the conditions of confidentiality and data ownership.
{"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_abf2"},"value":"Open access"}
| Indicate if special permissions are required to access a resource | Special permissions description |
|---|---|
| Yes | https://pdad.hostnet.solutions |
Access to data is restricted to authorized investigators and personnel via secure login credentials. Any use of the data requires compliance with confidentiality protocols, the GDPR, and, where applicable, prior approval from the scientific committee or study sponsor.
www.data-gouv.com
| Name | |
|---|---|
| Saif;AGHAR | sagefemme8@impact-dev.tn |
| Sarah;JONSHON | sarah.jonhson@impactgroup.tech |
FReSH-50257-draft-en
| Name | Affiliation |
|---|---|
| Walma GHARBI | INSERM TRANSFERT |