Aerobic Exercise, Rhumatoid Arthisis, Chronic Kidney Disease, Cardiovascular (CV) Risk
Conditions
Keywords
Systemic Inflammation, Arterial Stiffness, Hyperemic reactivity, Blood analyses
Brief summary
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: * Does an individualized aerobic exercise program reduce cardiovascular risk, as assessed arterial stiffness and endothelial function ? * What are the effects of this exercise program on inflammation and immunosenescence? 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: * Perform three physical activity sessions per week for six weeks (45-minute sessions at 60-80% of heart rate reserve); * Attend clinic visits at baseline, after the 6-week intervention, and at a 6-week follow-up after the intervention; * Undergo assessments including pulse wave velocity, hyperemic reactivity, and blood analyses.
Interventions
BEHAVIORALTherapeutic education
Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level.
BEHAVIORALAerobic exercise program
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%.
Sponsors
Jérôme Bouchan
UMR1098, EFS BFC, BESANCON
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Chronic Kidney Disease (CKD) or Rheumatoid Arthritis (RA), with no other risk factors related to the disease. * Having a glomerular filtration rate between 45 and 20 ml/min/1.73 m², corresponding to stages III and IV not on dialysis for patients with CKD ; or have a DAS 28 score ≥ 2.6 points for patients with RA. * Have a medical certificate stating that there are no adverse reactions to physical activity. * Affiliation with a French social security scheme or beneficiary of such a scheme.
Exclusion criteria
* Unstabilised corticosteroid therapy and/or \>10mg prednisone/day * Uncontrolled high blood pressure * Pregnant women * Impaired higher functions making it impossible to understand and adhere to an aerobic exercise program * Inability to perform physical exercise, regardless of the cause (neurological, central or peripheral, cardiovascular or respiratory, or musculoskeletal) * Legal incapacity or limited legal capacity * Subject unlikely to cooperate with the study and/or low cooperation anticipated by the investigator * Subject without health insurance * Subject is in the exclusion period of another study involving human subjects that may interfere with the results of this study, particularly by affecting inflammatory status and the cardiovascular system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial stiffness | From baseline to 12-weeks follow-up (three time points). | Arterial stiffness is measured with pulse wave velocity (PWV). The unit is metres per second. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Dysfunction | From baseline to 12-weeks follow-up (three time points). | 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 |
| Cardiovascular risk blood biomarkers | From baseline to 6-weeks (two time points), before and after the intervention. | The blood biomarkers analysed include inflammation cardiovascular risk markers : Galectin-3 and Arginase (unit : ng/mL, nanograms per millilitre). |
| Inflammatory Blood biomarkers | From baseline to 6-weeks (two time points), before and after the intervention. | The blood biomarkers analysed include inflammation markers : TNF, IL6, IL15, IL17 (unit : pg/mL, picograms per millilitre). |
| Senescence Blood biomarkers | From baseline to 6-weeks (two time points), before and after the intervention. | 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 (%). |
| Heart rate | From baseline to 12-weeks follow-up (three time points). | Cardiac parameters are measured using a heart rate monitor to determine the percentage of heart rate reserve during exercise (expressed as a percentage). |
| Heart rate variability | From baseline to 12-weeks follow-up (three time points). | 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. |
| Blood pressure | From baseline to 12-weeks follow-up (three time points). | Blood pressure is assessed using a tensiometer, and expressed in mmHg with systolic pressure and diastolic pressure. |
| Quality of life level | From baseline to 6-weeks (two time points), before and after the intervention. | 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. |
| Physical activity level | From baseline to 6-weeks (two time points), before and after the intervention. | 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). |
Countries
France
Contacts
CONTACTJérôme Bouchan, PhD
Outcome results
None listed