Aerobic ExercisePARCANCT07469540
Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis
A study testing Aerobic exercise program and Therapeutic education in people with Aerobic Exercise and Rhumatoid Arthisis, run by Jérôme Bouchan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aerobic Exercise, Rhumatoid Arthisis, Chronic Kidney Disease
- What is being tested?
- Aerobic exercise program and Therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
EPHI Platform
Besançon, 25000
Jérôme Bouchan, PhD, +33363082323, jerome.bouchan@umlp.fr
About this study
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:
Read more
- 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.
- Being tested
- Aerobic exercise program, Therapeutic education
- Keywords
- Systemic Inflammation, Arterial Stiffness, Hyperemic reactivity, Blood analyses
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programBehavioural
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 educationBehavioural
Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Aerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise Receives: Behavioral: Aerobic exercise program |
| Physical activity oriented group | Active comparator | Therapeutic education during 6 weeks (1 phone call / week), with advice and exchanges to improve physical activity Receives: Behavioral: Therapeutic education |
| Control group | No intervention | No intervention group during 6 weeks, participants have to maintain their lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Arterial stiffness is measured with pulse wave velocity (PWV). The unit is metres per second.
Measured: From baseline to 12-weeks follow-up (three time points).
Secondary outcomes (9)
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
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From baseline to 6-weeks (two time points), before and after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jérôme Bouchan
- Sponsor type
- University, hospital or other
- Collaborators
- UMR1098, EFS BFC, BESANCON, Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor-investigator, Jérôme Bouchan, University of Franche-Comté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469540
- Sponsor's protocol ID
- 2024-A02525-42
- Acronym
- PARCA
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07469540
- Acronym / sponsor ID
- PARCA / 2024-A02525-42
- Keywords
- Systemic Inflammation, Arterial Stiffness, Hyperemic reactivity, Blood analyses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jérôme BouchanUniversity, hospital or other
- Collaborators
- UMR1098, EFS BFC, BESANCON, Centre Hospitalier Universitaire de Besancon
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Aerobic exercise programAerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise |
| Physical activity oriented group | Active comparator | Behavioral: Therapeutic educationTherapeutic education during 6 weeks (1 phone call / week), with advice and exchanges to improve physical activity |
| Control group | No intervention | –No intervention group during 6 weeks, participants have to maintain their lifestyle |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise programAerobic 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%. | Behavioural | Experimental group |
| Therapeutic educationTherapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level. | Behavioural | Physical activity oriented group |
Primary outcome
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.
9 secondary outcomes
Endothelial Dysfunction
Time frame: 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.
Inflammatory Blood biomarkers
Time frame: 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.
Heart rate
Time frame: 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).
Blood pressure
Time frame: 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.
Physical activity level
Time frame: From baseline to 6-weeks (two time points), before and after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise program and Therapeutic education in people with Aerobic Exercise and Rhumatoid Arthisis, run by Jérôme Bouchan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Bouchan, PhD (+33363082323, jerome.bouchan@umlp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: From baseline to 12-weeks follow-up (three time points).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.