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

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 Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Aerobic Exercise; Rhumatoid Arthisis; Cardiovascular (CV) Risk
• Intervention / Treatment: Behavioral: Aerobic exercise program; Behavioral: Therapeutic education

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme Bouchan, PhD; Phone Number: +33363082323; Email: jerome.bouchan@umlp.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • EPHI Platform
    • Contact: Jérôme Bouchan, PhD; Phone Number: +33363082323; Email: jerome.bouchan@umlp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Aerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise	Behavioral: Aerobic 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%.
Active Comparator: Physical activity oriented group; Therapeutic education during 6 weeks (1 phone call / week), with advice and exchanges to improve physical activity	Behavioral: Therapeutic education; Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level.
No Intervention: Control group; No intervention group during 6 weeks, participants have to maintain their lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Jérôme Bouchan
• Collaborators: Centre Hospitalier Universitaire de Besancon; UMR1098, EFS BFC, BESANCON

Study record dates

Study Major Dates

• Study Start (Estimated): March 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Arterial Stiffness; Systemic Inflammation; Hyperemic reactivity; Blood analyses
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2024-A02525-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No