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| Name | Class |
|---|---|
| UMR1098, EFS BFC, BESANCON | UNKNOWN |
| Centre Hospitalier Universitaire de Besancon | OTHER |
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The goal of this clinical trial is to determine whether an aerobic exercise program can reduce cardiovascular risk in patients with systemic inflammation, such as those with rheumatoid arthritis and chronic kidney disease.
The main questions this study aims to address are:
Researchers will compare an individualized aerobic exercise program with a therapeutic education program (consisting of educational phone calls only) and a control group with no intervention.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Aerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise |
|
| Physical activity oriented group | Active Comparator | Therapeutic education during 6 weeks (1 phone call / week), with advice and exchanges to improve physical activity |
|
| Control group | No Intervention | No intervention group during 6 weeks, participants have to maintain their lifestyle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise program | Behavioral | Aerobic exercise program during 6 weeks, with 3 sessions / week. Each session includes 45 minutes of ergocycle, with 9 cycles of 4 minutes at 60% of heart rate and 1 minute at 80%. |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness | Arterial stiffness is measured with pulse wave velocity (PWV). The unit is metres per second. | From baseline to 12-weeks follow-up (three time points). |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Dysfunction | Endothelial Dysfunction is measured with hyperemic reactivity. The reactive hyperemia index (RHI) was used to assess endothelial function, while RHI < 1.67 defined as endothelial dysfunction | From baseline to 12-weeks follow-up (three time points). |
| Cardiovascular risk blood biomarkers |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived exertion | Perceived exertion is measured with Borg's scale (6-20 scale). Scores range from 6 to 20, with higher scores representing a greater perception of effort. | From baseline to 12-weeks follow-up (19 time points), at each exercise session. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérôme Bouchan, PhD | Contact | +33363082323 | jerome.bouchan@umlp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPHI Platform | Recruiting | Besançon | 25000 | France |
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| Therapeutic education | Behavioral | Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level. |
|
The blood biomarkers analysed include inflammation cardiovascular risk markers : Galectin-3 and Arginase (unit : ng/mL, nanograms per millilitre). |
| From baseline to 6-weeks (two time points), before and after the intervention. |
| Inflammatory Blood biomarkers | The blood biomarkers analysed include inflammation markers : TNF, IL6, IL15, IL17 (unit : pg/mL, picograms per millilitre). | From baseline to 6-weeks (two time points), before and after the intervention. |
| Senescence Blood biomarkers | The blood biomarkers analysed include senescence markers : CD45, CD4, CD8. These markers were presented with number of cells (absolute value, cellules/µL) and with the percentage (%). | From baseline to 6-weeks (two time points), before and after the intervention. |
| Heart rate | Cardiac parameters are measured using a heart rate monitor to determine the percentage of heart rate reserve during exercise (expressed as a percentage). | From baseline to 12-weeks follow-up (three time points). |
| Heart rate variability | Cardiac parameters are measured using a heart rate monitor to determine the heart rate variability (based on R-R intervals). Two main parameters were used: RMSSD and LF/HF ratio. | From baseline to 12-weeks follow-up (three time points). |
| Blood pressure | Blood pressure is assessed using a tensiometer, and expressed in mmHg with systolic pressure and diastolic pressure. | From baseline to 12-weeks follow-up (three time points). |
| Quality of life level | The quality of life was assessed with 36-Item Short Form Survey Instrument (SF-36 questionnaire), with physical composite score (0-100) and mental composite score (0-100) outputs. A higher score corresponds to a better quality of life. | From baseline to 6-weeks (two time points), before and after the intervention. |
| Physical activity level | The level of physical activity was assessed with short International Physical Activity Questionnaire (IPAQ, 7 items). Two indicators are then used with the overall level of physical activity (3 modalities) and the energy expenditure associated with this physical activity (in MET.h/week). | From baseline to 6-weeks (two time points), before and after the intervention. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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