Effect of Controlling Environmental Risk Factors in Established RA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.
研究概览
简要总结
- The factors contributing to the development of rheumatoid arthritis are multiple, with a role of the environment and a predisposing genetic background.
- Among the modifiable environmental factors :unbalanced diet, overweight, low physical activity, smoking, periodontal disease, stress have been identified as risk factors for developing RA.
- By causing low-grade inflammation and stimulation of the immune system (particularly through adipokines, citrullination phenomena and changes in the microbiota), these factors promote the onset of the disease and could also participate in the maintenance of inflammatory processes.
- Thus, obese subjects have more active RA, a lower therapeutic response, and weight loss is associated with lower disease activity ; sedentary lifestyle is associated with more active RA and increased physical activity has beneficial effects on RA; people who smoke respond less well to treatment; periodontal disease is associated with more active RA and their treatment is associated with a decrease in this activity.
- Finally, different methods having a beneficial impact on stress (mindfulness meditation, yoga, relaxation, etc.) have shown interesting results in patients with RA.
- It is important to note that all of these factors are also associated with an increased cardiovascular risk, the leading cause of death in RA.
- The combination of these factors probably has synergistic effects and it is therefore relevant to propose a correction of all these factors in the same program.
- We have developed a management program for environmental risk factors for RA based with experts including rheumatologists, nutritionists, smoking cessation specialists, periodontal disease specialists and stress specialists.
详细描述
Methodology:
- We will conduct a Phase 2 to one phase trial with A'Hern design.
- The patients included will have RA (ACR / EULAR 2010 criteria), with an active disease (2.6 <DAS 28 <5.1), and at least 3 risk factors among: BMI ≥25 kg / m², low physical activity , active smoking, periodontitis and anxiety.
- The primary endpoint will be the number of patients for whom at least 2 or 3 risk factors (depending on whether 3 present or 4-5 present at baseline) are corrected / in the process of being corrected at 6 months.
- The secondary endpoints will be:
A) Acceptability: number of patients agreeing to participate in the protocol / total number of screened patients fulfilling the inclusion criteria; questionnaires with EVA carried out at the end of the program; Membership of the program: online completion of questionnaires, use of the accelerometer, participation in teleconsultations and organized group sessions.
B) For each risk factors: number of patients who corrected it at 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA (ACR / EULAR 2010 criteria), with an active disease (2.6 <DAS 28 <5.1)
- •Basis treatment for at least 3 months and corticoids <= 10mg / day
- •And at least 3 risk factors among:
- •BMI ≥25 kg / m²
- •Low physical activity (IPAQ short version)
- •Active smoking
- •Periodontitis ( bone loss on dental panoramic)
- •Anxiety ( Beck anxiety Index > 16)
排除标准
- •Patient under protective measure or unable to consent
- •Patient for whom a change in basic treatment for RA is planned within 6 months
- •Active cancer
- •Active infection
- •Antibiotic therapy in the previous 3 months
- •No health cover
- •Unbalanced psychiatric pathologies
- •Pregnant or breastfeeding women
结局指标
主要结局
Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.
时间窗: 6 MONTHS
Number of patients for whom at least 2 or 3 risk factors (depending on whether 3 present or 4-5 present at baseline) are corrected / in the process of correction. Risk factors will be considered corrected / in the process of being corrected if: * Weight loss ≥5% of initial weight at 6 months (objective measurement of weight) and / or BMI at 6 months \< 25kg/m² * Complete smoking cessation (declarative assessment) * Correction of sedentary lifestyle with moderate to strong IPAQ AND increase of ≥2,000 steps / day compared to the initial assessment (on average 5 days / 7) (questionnaire and quantified assessment obtained with the pedometer and automatically reported on the platform) * Improvement in periodontal disease scores ≥4 points on 6 teeth assessed according to Ramfjord's recommendation (plaque index (Sillness and Loe index), gingival (Lobene index) and papillary bleeding index) (evaluation by the periodontologist) * Decrease in anxiety score from N class to N-1 class
次要结局
- Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)(MONTH 0)
- RA activity(3 MONTHS, 6 MONTHS)
- At least two risk factors (if 3 present at base) or at least three (if 4 or 5 present at base) are corrected / in the process of correction.(3 MONTHS)
- Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity(3 MONTHS, 6 MONTHS)
- To assess the acceptability and adherence of RA patients to the intervention program.(6 MONTHS)