Rheumatoid Arthritis Clinical Trial
— PREXCRIMOfficial title:
Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis
Verified date | April 2019 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to analyze the long-term effects of a physical exercise program on the cardiovascular system of people with Rheumatoid Arthritis (RA). Indeed, it is recognized that RA patients have cardiovascular problems and that regular physical exercise (exercise training) may be beneficial for the disease complications, incluse the cardiovascular risk. Unfortunately, these patients do not exercise enough for fear of joint pain or for fear of deteriorating their general physical condition. It is known that intermittent exercises, ie combining low and high intensity work phases, are particularly effective in the cardiovascular field. As it is possible that the high intensity phases be more difficult to sustain than the low intensity phases (joint pain and degradation of the inflammatory status), the investigators propose to study the effects of cold water immersion in the legs after performing this exercise, because the cold being recognized as limiting the pain and improving the inflammatory status.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 6, 2019 |
Est. primary completion date | March 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patient (male or female) between the ages of 20 and 80, diagnosed with rheumatoid arthritis without any other risk factor in relation to RA, and having a DAS-28 score between 2.6 and 6. - Signature of informed consent - Affiliation to a French social security scheme or beneficiary of such a scheme. Exclusion Criteria: - Unstabilized corticosteroids and / or> 10 mg prednisone / day; - Unstabilized hypertension; - Pregnant women; - Alteration of higher functions making comprehension and adherence to a conditioning program impossible (mini mental test <24); Patient who has performed intense physical exercise / physiotherapy within the previous 24 hours the interventions planned in this project; - Contraindication to immersion in cold water (a dermatological factor and / or vascular or respiratory cardiac dysfunction and / or cold intolerance syndrome and / or syndrome such as Raynaud's Syndrome); - Inability to perform physical exercise, regardless of its origin (neurological, central or peripheral, cardiovascular or respiratory or musculoskeletal); - Legal incapacity or limited legal capacity; - Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator; - Subject without health insurance; - Subject being in the exclusion period of another study or provided for by the "National Volunteer File". |
Country | Name | City | State |
---|---|---|---|
France | Clément Prati | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure wave analysis | The tonometry device measures brachial arterial pressures and assessment of compliance of large and small arteries.
This device records the shape of the pulse wave at the level of the radial artery using a sensor placed on the wrist (non-invasive measurement): the analysis of the shape of this wave makes it possible to obtain information on the compliance blood. The device includes a brachial cuff that makes it possible to measure arterial pressures simultaneously with the measurement of arterial stiffness. The systolic and diastolic blood pressure values will be collected at each resting phase. This pressure wave analysis will be analysed concomitantly with assessment of central arterial compliance (pulse wave velocity measurement) as a composite outcome of the assessment of arterial compliance in patients following the rehabilitation protocol . |
Week 6 | |
Primary | Assessment of central arterial compliance | The assessment of central arterial compliance will be performed by measuring the pulse wave velocity on the carotid-femoral segment.
The evaluation of the arterial compliance of the territories concerned (legs) or not (arms) by the exercises, will be carried out by the respective measurements of the pulse wave velocity on the carotid-pedal and carotid-radial segments. This assessment of central arterial compliance (pulse wave velocity measurement) will be analysed concomitantly with pressure wave analysis as a composite outcome of the assessment of arterial compliance. |
Week 6 | |
Secondary | Disease activity Score 28 | the rating of pain in joint pressure and joint swelling on the proximal interphalangeal (PPI), metacarpophalangeal (MCP) joints of the hands, wrists, elbows, shoulders and knees.
This scale will be analysed concomitantly with measurement of certain blood markers of inflammation and an articular ultrasound as a composite outcome of the disease activity. |
Week 6 | |
Secondary | Disease activity : blood markers of inflammation | Measurement of certain blood markers of inflammation (IL6; PCR; TNF-a) : 3 blood samples of approximately 20 mL of blood will be taken for the subjects who are doing the whole program and only two blood tests for the other subjects. Venous blood samples will be used to determine serum marker concentrations of C-reactive protein inflammation. The assay of two other blood markers of IL-6 inflammation and TNF-a conventionally used in the clinical follow-up of this type of patient will also be performed.
This measurement of certain blood markers of inflammation will be analysed concomitantly with DAS-28 clinical test and an articular ultrasound as a composite outcome of the disease activity. |
Week 6 | |
Secondary | Disease activity : articular ultrasound | The articular ultrasound will be performed on 32 joints of the hands, wrists and feet using a qualitative synovitic score in B mode and Doppler mode each rated from 0 to 32, a total score ranging from 0 to 64.
This articular ultrasound will be analysed concomitantly with DAS-28 clinical test and measurement of certain blood markers of inflammation as a composite outcome of the disease activity. |
Week 6 | |
Secondary | Cardiovascular function : blood pressure | blood pressure will be assessed before and after the rehabilitation protocol.
This blood pressure assessment will be analysed concomitantly with heart rate, cardiac index and elasticity of large and small arteries as a composite outcome of cardiovascular function. |
Week 6 | |
Secondary | Cardiovascular function : cardiac index | The cardiac index will be assessed before and after the rehabilitation protocol.
The cardiac index corresponds to the quotient of the left ventricular cardiac output per minute by the body surface, thus connecting the cardiac performance to the size of the individual. The unit of measure is liter per minute per square meter (L / min / m2). This cardiac index assessment will be analysed concomitantly with blood pressure assessment, heart rate and elasticity of large and small arteries as a composite outcome of cardiovascular function. |
Week 6 | |
Secondary | Cardiovascular function : elasticity of arteries | The elasticity of large and small arteries will be assessed before and after the rehabilitation protocol.
This elasticity of arteries assessment will be analysed concomitantly with blood pressure assessment, heart rate and cardiac index as a composite outcome of cardiovascular function. |
Week 6 | |
Secondary | Assessment of functional disability : HAQ | The Health Assessment Questionnaire (HAQ) is a tool to measure specific functional disability for rheumatoid arthritis. | Week 6 | |
Secondary | Assessment of physical activity (SQUASH) | The Short Questionnaire to Assess Helath enhancing physical activity (SQUASH) is a questionnaire to evaluate the average energy expenditure during a week. | Week 6 | |
Secondary | Assessment of quality of life and well-being (SF-36) | The Short-forme 36 (SF-36) questionnaire will be used to assess the quality of life and well-being.
This SF-36 questionnaire will be analysed concomitantly with HAQ and SQUASH questionnaires as a composite outcome of the assessment of functional disability, physical activity and quality of life and well-being. |
Week 6 |
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