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NCT Number: NCT05578495

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

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.

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Key information

Conditions

Exercise Behavior Chronic Disease Comorbidities and Coexisting Conditions Comorbidity Digital Technology Disease Attributes Motor Activity Multimorbidity Non Communicable Diseases Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location status: Recruiting

Location contact

Anne Tournadre

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

+33473754963

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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.

Treatment and study plan

Accelerometer data

Other

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

Primary outcomes

  1. Occurrence of one additional comorbidity in patients with chronic diseases.

    Time frame: 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.

  2. Digital signature of sedentary lifestyle and PA in patients with chronic diseases.

    Time frame: 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 outcomes

  1. Occurence of multimorbidity in patients with chronic diseases.

    Time frame: Year 1

    Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).

  2. Occurence of multimorbidity in patients with chronic diseases.

    Time frame: year 2

    Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).

  3. Occurence of multimorbidity in patients with chronic diseases.

    Time frame: Year 3

    Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).

  4. Occurence of multimorbidity in patients with chronic diseases.

    Time frame: Yaer 4

    Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).

  5. Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.

    Time frame: 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.

  6. Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.

    Time frame: 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.

  7. Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.

    Time frame: 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.

  8. Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.

    Time frame: 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.

  9. Correlation of PA/sendetary and treatments for chronic diseases.

    Time frame: 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.

  10. Correlation of PA/sendetary and treatments for chronic diseases.

    Time frame: 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.

  11. Correlation of PA/sendetary and treatments for chronic diseases.

    Time frame: 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.

  12. Correlation of PA/sendetary and treatments for chronic diseases.

    Time frame: 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.

  13. Correlation of PA and sedentary measures and quality of life (QOL) of patients

    Time frame: 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.

  14. Correlation of PA and sedentary measures and quality of life (QOL) of patients

    Time frame: 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.

  15. Correlation of PA and sedentary measures and quality of life (QOL) of patients

    Time frame: 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.

  16. Correlation of PA and sedentary measures and quality of life (QOL) of patients

    Time frame: 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.

  17. Occurrence of hospitalization and/or surgery of patients in each cohort

    Time frame: Year 1

    Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).

  18. Occurrence of hospitalization and/or surgery of patients in each cohort

    Time frame: Year 2

    Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).

  19. Occurrence of hospitalization and/or surgery of patients in each cohort

    Time frame: Year 3

    Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).

  20. Occurrence of hospitalization and/or surgery of patients in each cohort

    Time frame: Year 4

    Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Acronym: eMOB

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 13, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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