NCT05578495

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2023Dec 2030

First Submitted

Initial submission to the registry

September 19, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 7, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

September 19, 2022

Last Update Submit

September 19, 2025

Conditions

Keywords

Physical ActivitySedentary LifestyleChronic DiseasesComorbiditiesMultimorbidityPersonal digital healthPersonalized medecine

Outcome Measures

Primary Outcomes (2)

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

    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.

    year 4

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

    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.

    Year 4

Secondary Outcomes (20)

  • Occurence of multimorbidity in patients with chronic diseases.

    Year 1

  • Occurence of multimorbidity in patients with chronic diseases.

    year 2

  • Occurence of multimorbidity in patients with chronic diseases.

    Year 3

  • 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 1

  • +15 more secondary outcomes

Study Arms (1)

Chronic diseases

OTHER

Cohort Study

Other: Accelerometer data

Interventions

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

Chronic diseases

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorNoncommunicable DiseasesChronic Disease

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Tournadre

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

October 13, 2022

Study Start

December 7, 2023

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations