Physical Activity and Cardiovascular Risk

NCT06440369 | Not Yet Recruiting DMC

• 1 other identifier: UnivFranche-Comte
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pulse wave velocity

  The evaluation of central and peripheral arterial compliance will be carried out by measuring the pulse wave velocity on the carotid-femoral and carotid-radial segments respectively. These evaluations are carried out using the Complior device (Complior SP®, Artech Medical, Pantin, France). This system is equipped with an interface between the piezoelectric sensors and the laptop which is used to save the recordings. The search for the best site at the radial, femoral and carotid levels will be done by palpation. Once the sites have been identified, the operator will mark them using a hypoallergenic marker so as to find the same measurement positions during the session (for the experimental and healthy group). The sensors will be held in place with a velcro system or by the operator. After checking the quality of the signal and after leaving the subject to rest for a few minutes, the operator can record the signal.

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

• Reactive hyperemia

  The evaluation of the hyperemic reaction will be carried out by ENDOPAT (Itamar Medical®, Caesarea, Israel). This tool quantifies the peripheral vasodilator response (reactive hyperemia) via an electronic finger cot in a non-invasive manner, following occlusion of vascular flow. The measuring device is made up of two probes with an inflation system placed on the index finger of each hand. On the side of the finger tested, after measuring the basal flow, a cuff positioned at the level of the arm is inflated above the systolic pressure for 5 minutes, then released creating a reflex vasodilation measured by the ENDOPAT. Endothelial function is calculated by the relationship between the average amplitude of reactive hyperemia over a 1 minute period starting 1.5 minutes after cuff deflation and the baseline level.

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

Secondary Outcomes (5)

• Inflammation level

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

• Level of quality of life

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

• Level of physical activity

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

• Systolic pressure (mmHg) and diastolic pressure (mmHg)

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

• Heart rate (HR, bpm)

  Assessment on the same day of the inclusion visit and 6 consecutive weeks later.

Study Arms (3)

Training group

EXPERIMENTAL

Patients will begin the individualized physical activity program during the inclusion visit and will continue it for 6 weeks, with 3 sessions per week (for a total of 18 sessions). At the end, patients will be able to resume their usual activities and will be evaluated again 6 weeks after stopping the program. The training program will be supervised by a physical activity instructor adapted and carried out at the CHRU, in the Nephrology or Rheumatology Department depending on the patient's pathology.

Other: Training group

Physical activity orientation group

ACTIVE COMPARATOR

Patients will be encouraged to engage in physical activity and will receive phone calls for instructions regarding this practice. They will be contacted by telephone each week, for a total of 6 calls, each lasting approximately 10 minutes.

Other: Physical activity orientation group

Control group

NO INTERVENTION

Interventions

Training group OTHER

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.

Training group

Physical activity orientation group OTHER

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.

Physical activity orientation group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject (man or woman) over 50 years old, without diagnosis of chronic disease.
• Patient (man or woman) over 50 years old, with a diagnosis of CKD or RA without other risk factors related to the disease.
• Have a medical certificate of no contraindication to AP.
• Have a glomerular filtration rate between 45 and 29 ml/min/1.73 m2, corresponding to non-dyalized stages III and IV for patients with CKD.
• Have a DAS-28 score ≥ 2.6 points for patients with RA.
• Signature of informed consent.
• Affiliation to a French social security scheme or beneficiary of such a scheme.

You may not qualify if:

• unstabilized corticosteroid therapy and/or \>10 mg of prednisone/day;
• unbalanced high blood pressure;
• pregnant women ;
• alteration of higher functions making understanding and adherence to a conditioning program impossible;
• inability to perform physical exercise, whatever the origin (neurological, central or peripheral, cardiac, vascular or respiratory or musculoskeletal).
• Legal incapacity or limited legal capacity
• Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
• Subject without health insurance

Sponsors & Collaborators

• University of Franche-Comté: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Renal Insufficiency, Chronic; Motor Activity

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; 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; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Control group (CG): Patients will continue their lifestyle. Physical activity orientation group (G0-AP): Patients will be encouraged to practice physical activity and will benefit from telephone calls for instructions regarding this practice. They will be contacted by telephone each week, for a total of 6 calls, each lasting approximately 10 minutes. Training group (GE): Patients will begin the individualized PA program during the inclusion visit and will continue it for 6 weeks, at a rate of 3 sessions per week (for a total of 18 sessions). At the end, patients will be able to resume their usual activities and will be evaluated again 6 weeks after stopping the program. The training program will be supervised by a physical activity instructor adapted and carried out at the CHRU, in the Nephrology or Rheumatology Department depending on the patient's pathology.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 3, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-06