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

NCT07469540 | Recruiting

• 1 other identifier: 2024-A02525-42
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aerobic Exercise; Chronic Kidney Disease; Cardiovascular (CV) Risk; Rhumatoid Arthisis

Keywords

Systemic Inflammation; Arterial Stiffness; Hyperemic reactivity; Blood analyses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Endothelial Dysfunction

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

• Cardiovascular risk blood biomarkers

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

• Inflammatory Blood biomarkers

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

• Senescence Blood biomarkers

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

• Heart rate

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

Other Outcomes (1)

• Perceived exertion

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

Study Arms (3)

Experimental group

EXPERIMENTAL

Aerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise

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

Behavioral: Therapeutic education

Control group

NO INTERVENTION

No intervention group during 6 weeks, participants have to maintain their lifestyle

Interventions

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%.

Experimental group

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.

Physical activity oriented group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jérôme Bouchan: lead
• UMR1098, EFS BFC, BESANCON: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator

Study Sites (1)

EPHI Platform

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jérôme Bouchan, PhD

CONTACT

+33363082323; jerome.bouchan@umlp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher PhD

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 13, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)