Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis

ConditionsAerobic Exercise Rhumatoid Arthisis Chronic Kidney Disease Cardiovascular (CV) Risk

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorJérôme Bouchan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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%.
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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Experimental groupExperimental treatment 1 intervention

Group B: Physical activity oriented groupActive comparator 1 intervention

Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Arterial stiffness

Arterial stiffness is measured with pulse wave velocity (PWV). The unit is metres per second.

Time frame

From baseline to 12-weeks follow-up (three time points).

Secondary outcomes

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

Time frame

From baseline to 12-weeks follow-up (three time points).

Cardiovascular risk blood biomarkers

The blood biomarkers analysed include inflammation cardiovascular risk markers : Galectin-3 and Arginase (unit : ng/mL, nanograms per millilitre).

Time frame

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).

Time frame

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 (%).

Time frame

From baseline to 6-weeks (two time points), before and after the intervention.

Other outcomes

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.

Time frame

From baseline to 12-weeks follow-up (19 time points), at each exercise session.