Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295848
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-09-01
Brief Title:
The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients
Sponsor:
Kayseri City Hospital
Organization:
Kayseri City Hospital
Study Overview
Official Title:
The Effects of 6-week Cardiac Rehabilitation Programme on Cardiovascular Disease Risk Systolic and Diastolic Blood Pressure and Disease Activity in Hypertensive Rheumatoid Arthritis Patients A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
CARDIRA
Brief Summary:
The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment
Subjects will be randomly assigned to one of two groups 1 standard of care SOC treatment or 2 SOC plus a 6 week CR program
Subjects will be randomly assigned to one of two groups 1 standard of care SOC treatment or 2 SOC plus a 6 week CR program
Detailed Description:
Rheumatoid arthritis RA is a chronic systemic auto-immune disease characterized by inflammation and structural damage in synovial joints but also has extra-articular involvements such as the cardiovascular system RA patients have higher mortality rates than the general population and approximately half of premature deaths are due to cardiovascular comorbidities Traditional risk factors especially hypertension HTN play a key role in the development of cardiovascular diseases CVD
In chronic inflammatory diseases such as RA autoimmunity is a cause of HTN as well as a result of physical damage to the vascular wall Mild blood pressure elevation caused by specific HTN triggers such as salt retention angiotensin-II or genetic susceptibility leads to neoantigen release through tissue damage These neoantigens are recognized by antigen-presenting cells and lead to the differentiation of CD4 naïve-T lymphocytes into Th1 and Th17 cells IL-17 and IFN-γ expression causes local inflammation in the vascular wall endothelial dysfunction and arterial stiffness Thus HTN causes an increase in CVD risk through a common pathogenesis mechanism with RA
European League Against Rheumatism EULAR recommendations emphasize that rheumatologists should be responsible for CVD risk management in RA However both RA and HTN treatment is generally administered pharmacologically without focusing on CVD risk Patients may be recommended regular exercise and lifestyle changes according to EULAR recommendation guide for CVD risk management One possible intervention that could be used to decrease CVD risk caused by both diseases is cardiac rehabilitation CR program in which regular exercise is one of the main components But RA patients especially those with cardiovascular comorbidities are rarely referred to the CR program
This study will help to clarify the effects of the CR program added to the pharmacological treatment of these patients on cardiovascular mortality risk Framingham risk score and QRISK-3 score blood pressure 24-Hour holter monitoring disease activity DAS28-CRP aerobic capacity VO2max quality of life 36-Item Short Form Survey and psychological state Beck depression inventory
In chronic inflammatory diseases such as RA autoimmunity is a cause of HTN as well as a result of physical damage to the vascular wall Mild blood pressure elevation caused by specific HTN triggers such as salt retention angiotensin-II or genetic susceptibility leads to neoantigen release through tissue damage These neoantigens are recognized by antigen-presenting cells and lead to the differentiation of CD4 naïve-T lymphocytes into Th1 and Th17 cells IL-17 and IFN-γ expression causes local inflammation in the vascular wall endothelial dysfunction and arterial stiffness Thus HTN causes an increase in CVD risk through a common pathogenesis mechanism with RA
European League Against Rheumatism EULAR recommendations emphasize that rheumatologists should be responsible for CVD risk management in RA However both RA and HTN treatment is generally administered pharmacologically without focusing on CVD risk Patients may be recommended regular exercise and lifestyle changes according to EULAR recommendation guide for CVD risk management One possible intervention that could be used to decrease CVD risk caused by both diseases is cardiac rehabilitation CR program in which regular exercise is one of the main components But RA patients especially those with cardiovascular comorbidities are rarely referred to the CR program
This study will help to clarify the effects of the CR program added to the pharmacological treatment of these patients on cardiovascular mortality risk Framingham risk score and QRISK-3 score blood pressure 24-Hour holter monitoring disease activity DAS28-CRP aerobic capacity VO2max quality of life 36-Item Short Form Survey and psychological state Beck depression inventory
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