Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities in Chronic Diseases (eMOB)

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05578495

Collaborator

(none)

700

Enrollment

Location

Arm

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Sedentary Behavior Non Communicable Diseases Comorbidities and Coexisting Conditions Comorbidity Multimorbidity Digital Technology	Other: Accelerometer data	N/A

Detailed Description

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 :

The occurrence of comorbidity is monitored every year during follow-up visits of the patients. Physical activity and sedentary lifestyle is assessed using accelerometer and wearable sensors. The combination of quantitative analysis of movement with a more detailed analysis of movement and sequences of movements, and a personalization of the algorithm according to the disease and the context, could make it possible to establish predictive signatures either of the disease itself or of associated complications.

700 patients will be included in the study.They will be followed for 4 years with :

An annual visit during which :
clinical data in the routine follow-up will be collected (BMI, waist circumference, blood pressure, heart rate, comorbidities, activity and severity scores specific to each disease and used for the routine follow-up, treatments, lifestyle, family and socio-professional situation, education level)
comorbidities will be noted by the list used for the study
physical capacity will be assessed with the 6-minute walk test and the hand grip
questionnaires about Pain (QCD), Fatigue (FACIT-F), Anxiety and Depression (HADs), Quality of life (WhoQol-BREF), Poverty (EPICES), Physical activity questionnaire (RPAQ), Barriers and Facilitators to physical activity questionnaire (B&F-AP), Sleep and daytime sleepiness (PSQI and Epworth), treatment compliance (MARS) will be completed
specific data for each pathology in each cohort will be collected
Accelerometer data 3 times a year for 5 days (3 weekdays and 2 weekend days) will be collected
Electronic patient report outcomes (e-PRO) every 4 months concerning the socio-professional situation of the patients, alcohol and tobacco consumption, skipping meals and snacking between meals, health problems they may encounter during the study. Numerical scales between 0 and 10 will be completed to assess disease status, health status, pain, sleep, fatigue, psychological well-being, and anxiety.

Among the included patients, 10 patients per cohort will participate in the preliminary feasibility phase of the study before starting the follow-up in the study. It is a validation of the acquisition modalities of the pre-selected sensors and a calibration on representative samples of patients with the different chronic pathologies studied (locomotor, respiratory, metabolic, psychiatric, pain).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2029

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Other: Chronic diseases Cohort Study	Other: Accelerometer data Patients will wear an accelerometer 3 times a year for 5 days (3 weekdays and 2 weekend days), the data will be collected

Arm

Intervention/Treatment

Other: Chronic diseases

Cohort Study

Other: Accelerometer data

Patients will wear an accelerometer 3 times a year for 5 days (3 weekdays and 2 weekend days), the data will be collected

Outcome Measures

Primary Outcome Measures

Occurrence of one additional comorbidity in patients with chronic diseases. [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.
Digital signature of sedentary lifestyle and PA in patients with chronic diseases. [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.

Secondary Outcome Measures

Occurence of multimorbidity in patients with chronic diseases. [Year 1]
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Occurence of multimorbidity in patients with chronic diseases. [year 2]
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Occurence of multimorbidity in patients with chronic diseases. [Year 3]
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Occurence of multimorbidity in patients with chronic diseases. [Yaer 4]
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition. [Year 1]
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition. [Year 2]
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition. [Year 3]
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition. [Year 4]
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Correlation of PA/sendetary and treatments for chronic diseases. [Year 1]
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Correlation of PA/sendetary and treatments for chronic diseases. [year 2]
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Correlation of PA/sendetary and treatments for chronic diseases. [Year 3]
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Correlation of PA/sendetary and treatments for chronic diseases. [Year 4]
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Correlation of PA and sedentary measures and quality of life (QOL) of patients [Year 1]
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status. The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Correlation of PA and sedentary measures and quality of life (QOL) of patients [Year 2]
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status. The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Correlation of PA and sedentary measures and quality of life (QOL) of patients [year 3]
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status. The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Correlation of PA and sedentary measures and quality of life (QOL) of patients [Year 4]
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status. The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Occurrence of hospitalization and/or surgery of patients in each cohort [Year 1]
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Occurrence of hospitalization and/or surgery of patients in each cohort [Year 2]
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Occurrence of hospitalization and/or surgery of patients in each cohort [Year 3]
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Occurrence of hospitalization and/or surgery of patients in each cohort [Year 4]
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.

Exclusion Criteria:

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.