Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities Over 4 Years of Follow-up in Chronic Diseases (eMOB) : a Prospective Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Digital signature of sedentary lifestyle and PA in patients with chronic diseases.
研究概览
简要总结
Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism, fibromyalgia and anxiety disorders. In these diseases, low-intensity PA often represents the main PA and the quantity of PA is correlated with health parameters.
This study aims to identify a typical profile (signature) in relation to the appearance of other chronic diseases, complications of your disease, from recording your physical activity and sedentary lifestyle by sensors evaluating very precisely the movements and taking into account the characteristics and disability related to your disease. The results of this study would therefore make it possible to identify this signature even before the appearance of complications or other diseases.
详细描述
Study design :
eMOB study is a monocentric prospective cohort study. We aim to explore in a longitudinal study the association of a digital signature of PA and sedentary lifestyle with the development of at least one additionnal comorbidity overs 4 years of follow-up in chronic diseases.
Population :
Patients with inflammatory rheumatic disease(rheumatoid arthritis and spondyloarthritis), pre-surgical knee and hip osteoarthritis, major depressive disorder and bipolar disorder, type 2 diabetes, obesity, COPD and chronic pain followed up in the observational cohorts specific to each pathology at the CHU of Clermont Ferrand, will be proposed to participate in the study during their follow-up visit.
Method :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient follow-up at CHU Clermont-Ferrand for a chronic disease in one of the following observational cohorts:
- •Inflammatory rheumatic disease(rheumatoid arthritis, spondyloarthritis) included in the RCVRIC cohort (CPP Sud-Est VI N° ID-RCB- A01847-40)
- •Pre-surgical knee and hip osteoarthritis (Evalmob) (ID-RCB N° 2019- A01017-50)
- •Major depressive disorder included in the FACE-DR cohort (CNIL agreement: DR- 2015-673) and Bipolar disorder included in the FACE-BD cohort (CPP Ile de France IX; January 18, 2010) of the Adult Psychiatry Department B
- •Type 2 diabetes included in the cohort of the sport medicine service "Rehabilitation T2" (CNIL agreement 0164)
- •Obesity included in the "Obesity" sports medicine service cohort (CNIL agreement 0164)
- •COPD included in the "COPD Rehabilitation" sports medicine service cohort (CNIL agreement 0164)
- •Chronic pain cohort (eDOL) (CPP West II N° ID-RCB 2020-A02027-32)
- •Affiliation to a social security system.
- •Able to provide written informed consent to participate in the research.
排除标准
- •Inability to practice physical activity
- •Pregnant or breastfeeding
- •Refusal to participate
- •Minors or adults under the protection of the law or under the protection of justice.
结局指标
主要结局
Digital signature of sedentary lifestyle and PA in patients with chronic diseases.
时间窗: Year 4
A sensor of movement will be worn by the patients for 5 days every 4 months during the study, to detect and quantify the physical activity and the sedentarity according to their intensity. This sensor will be accelerometer, allowing the acquisition of movements second by second. The analysis of the data from the sensors, the occurrence of a new comorbidity, the clinical data will allow to establish an algorithm to define a profile (digital signature) of occurrence of a new chronic disease.
Occurrence of one additional comorbidity in patients with chronic diseases.
时间窗: year 4
Association of a digital signature of PA and sedentary lifestyle with the development of at least one additional comorbidity over 4 years of follow-up.
次要结局
- Occurence of multimorbidity in patients with chronic diseases.(Yaer 4)
- Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.(Year 4)
- Occurrence of hospitalization and/or surgery of patients in each cohort(Year 4)
- Correlation of PA/sendetary and treatments for chronic diseases.(Year 4)
- Correlation of PA and sedentary measures and quality of life (QOL) of patients(Year 4)