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

Jérôme Bouchan90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aerobic Exercise Rhumatoid Arthisis Chronic Kidney Disease

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

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.

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts