Physical Activity and Cardiovascular Risk

Summary

Physical activity (PA) is essential for the prevention and treatment of chronic conditions. Despite its benefits, global physical inactivity is prevalent, contributing to chronic diseases and premature mortality. For patients with chronic kidney disease (CKD) and rheumatoid arthritis (RA), PA is particularly beneficial as it improves endothelial health, reduces cardiovascular risk, diminishes inflammation, and enhances quality of life. Given the chronic inflammation and immune system dysregulation in CKD and RA, PA may mitigate these effects and improve patient outcomes. The primary objective of this study is to evaluate the effects of a personalized aerobic exercise program on cardiovascular risk in patients with CKD or RA. The secondary objectives are to assess the effects on inflammation and immunosenescence; investigate the relationship between inflammation, immunosenescence, and various health outcomes; compare the impacts of chronic PA and PA guidance on cardiovascular risk, disease activity, lifestyle habits, cognitive functions, and quality of life.

This study presents an interventional design. A total of 105 subjects are expected to participate in this study, including 45 CKD patients and 45 RA patients. Participants will be stratified by PA level and cardiovascular risk (SCORE 2 scale) and then randomized into three groups: Control Group: 15 CKD and 15 RA patients; Therapeutic Education Group: 15 CKD and 15 RA patients; and Experimental Group: 15 CKD and 15 RA patients.

The inclusion criteria are: age \> 50 years; diagnosed with CKD or RA; glomerular filtration rate between 45 and 29 ml/min/1.73 m² for CKD; DAS-28 score ≥ 2.6 for RA; medical clearance for PA; informed consent and affiliation with French social security. The exclusion criteria are: unstable corticosteroid therapy or \>10 mg prednisone/day; uncontrolled hypertension; pregnancy; cognitive impairment preventing adherence to the program; inability to perform PA; legal incapacity or anticipated poor cooperation; lack of health insurance and participation in an incompatible study.

The primary efficacy criterion of this study is changes in endothelial function (macrovascular arterial stiffness) and the secondary efficacy criteria are: endothelial function (microvascular hyperemia test); levels of inflammation and immunity (blood tests); physical activity levels and quality of life (questionnaires); disease-related functional impairment; disease activity and cognitive function.

Patient screening will begin with the identification of eligible patients in the Nephrology and Rheumatology departments. Day 0 will be the selection visit for participant information and consent. A week after Day 0, the inclusion visit and initial assessment (arterial stiffness, endothelial function, disease impact, and blood markers for immunosenescence and inflammation, blood pressure, heart rate, PA level, quality of life, and cognitive functions) will be conducted for all patients. Next, only the patients in the experimental group will carry out a 47-minute cycling intermittent exercise session, perceived exertion assessment, and post-exercise reassessment. They will redo the assessments after the exercise. They will have another 16 sessions of supervised exercise by a health professional and a final session identical to the first for reassessment. Patients in the physical activity guidance group will not undertake a physical exercise program but will receive one call per week to discuss the physical activities performed and get answers to their questions on the subject. The control group will continue with their usual lifestyle habits.

Conditions

• Rheumatoid Arthritis
• Chronic Kidney Diseases
• Endothelial Dysfunction
• Arterial Stiffness
• Exercise

Interventions

OTHER

Training group

The patient will perform an intermittent exercise which consists of nine 5-minute cycles with a succession of work (top: 1 minute; bottom: 4 minutes). The high-intensity work phase will be adjusted so as to achieve a target Heart Rate (HR) corresponding to resting HR + 80% reserve HR (reserve HR = (200 - age) - resting HR). The low-intensity work phase will be adjusted to achieve a target maximum HR corresponding to resting HR + 60% reserve HR. In total duration, the exercise presents a submaximal intensity, commonly used in exercise rehabilitation studies carried out with various pathologies. It is an intensity capable of promoting benefits on the cardiovascular aspect without representing a severe intensity for the patient. In order to adapt the training and guarantee patient safety, the first exercise session will be carried out with an alternation between a high-intensity work phase of resting HR + 70% reserve HR and a work phase. at low intensity of resting HR + 50% reserve HR.

OTHER

Physical activity orientation group

Every week, for around ten minutes, patients in the AP orientation group will be contacted by telephone. The main objective of this exchange is to provide targeted advice on physical activity, its role, its objectives as well as its different ways of carrying it out. The second objective is to provide each week a personalized objective for each patient which can evolve over the weeks to increase levels of physical activity as far as possible. During each call, the evaluator will practice reflective listening, ask open-ended questions to facilitate the exchange, value and summarize the patient.

Sponsors & Collaborators

• University of Franche-Comté

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2026-10-30

Completion

2026-12-30