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

March 10, 2026 updated by: Jérôme Bouchan

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • EPHI Platform
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arterial stiffness
Time Frame: 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.
From baseline to 12-weeks follow-up (three time points).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Endothelial Dysfunction
Time Frame: 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
From baseline to 12-weeks follow-up (three time points).
Cardiovascular risk blood biomarkers
Time Frame: 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).
From baseline to 6-weeks (two time points), before and after the intervention.
Inflammatory Blood biomarkers
Time Frame: 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).
From baseline to 6-weeks (two time points), before and after the intervention.
Senescence Blood biomarkers
Time Frame: 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 (%).
From baseline to 6-weeks (two time points), before and after the intervention.
Heart rate
Time Frame: 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).
From baseline to 12-weeks follow-up (three time points).
Heart rate variability
Time Frame: 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.
From baseline to 12-weeks follow-up (three time points).
Blood pressure
Time Frame: 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.
From baseline to 12-weeks follow-up (three time points).
Quality of life level
Time Frame: 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.
From baseline to 6-weeks (two time points), before and after the intervention.
Physical activity level
Time Frame: 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).
From baseline to 6-weeks (two time points), before and after the intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived exertion
Time Frame: From baseline to 12-weeks follow-up (19 time points), at each exercise session.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jérôme Bouchan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire de Besancon
UMR1098, EFS BFC, BESANCON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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