NCT04375280

Brief Summary

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of "dysmobility" in patients with chronic illness

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
114mo left

Started Aug 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Aug 2020Aug 2035

First Submitted

Initial submission to the registry

April 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2035

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

15 years

First QC Date

April 27, 2020

Last Update Submit

May 27, 2025

Conditions

Joint OsteoarthritisAtherosclerosis of the Distal Arteries, Without GangreneParkinson DiseaseChronic Obstructive Pulmonary Disease, UnspecifiedObesity, Unspecified

Keywords

PreventionMobilityAltered mobilityRisk factorsChronic illnessChronic pathologiesPhysical capacitiesPhysical testActivity limitations

Outcome Measures

Primary Outcomes (5)

  • dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Day 0

  • dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Month 6

  • dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Year 1

  • dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Year 2

  • dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Year 5

Secondary Outcomes (459)

  • The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Day 0

  • Weight (Kg).

    Day 0

  • Weight (Kg).

    Month 6

  • Weight (Kg).

    Year 1

  • Weight (Kg).

    Year 2

  • +454 more secondary outcomes

Study Arms (1)

Cohort 1

EXPERIMENTAL

Participants will be involved in a long-term evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 5 years with evaluations taking place at inclusion, 6 months, at 1, 2 and 5 years

Other: Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.

Interventions

Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.OTHER

Firstly, volunteers will be invited to complete online questionnaires on a secure platform. The mobility assessment will be carried out initially (t1) and up to a maximum of 4 times (t1 to t4) as part of a day hospitalization. Questionnaires will be diverse (SF36, KOOS, HOOS, BROCKER, MNA, TAMPA, etc.) in order to assess several aspects that compose mobility. Physical evaluations will include various validated tests (isokinetic strength measure, TUG, 6MWT, Berg Balance Scale, etc.)

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Man or woman aged 18 to 90.
  • Patients with chronic pathology contributing to impaired mobility.
  • Volunteers who have given their written consent.
  • Affiliated to French health care system (for France)

You may not qualify if:

  • Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
  • People with poorly controlled or unstable cardiovascular disease.
  • Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
  • Non-autonomous patient
  • Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
  • People excluded from another study.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Parkinson DiseasePulmonary Disease, Chronic ObstructiveObesityChronic Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Frédéric Costes

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 5, 2020

Study Start

August 27, 2020

Primary Completion (Estimated)

August 26, 2035

Study Completion (Estimated)

August 26, 2035

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

FR(1)