Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04375280 En recrutement

Titre

Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort (EVALMOB)

Type

Interventional

Pathologie

Maladie chronique
Gangrène
Bronchopneumopathies obstructives
Obésité
Maladie de Parkinson
Broncho-pneumopathie chronique obstructive
Athérosclérose

Phase

N/A

Promoteur

University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)

Date de début

août 2020

Date de fin

août 2035

Dernière mise à jour

29 mai 2025

Résumé

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

Détail

Voir le détail We propose to constitute a prospective cohort of subjects carrying chronic disease. The objective is to explore all the different components of mobility (balance, muscle force, body composition, walking ability, metabolism, etc.), to assess their impact on the functional capacity of individuals and to identify their potential interactions. Processing this data could ultimately allow the development of a model to determine a composite standard profile of "dysmobility" in patients with chronic disease. In the present protocol, parameters will be measured on five occasions (at inclusion, at 6 months from the inclusion day, at 1,2 and 5 year(s) from the inclusion day). All tests will be performed on the same day. New assessments will be done on the same principle as the initial evaluation. Statistical analyses will be carried out using Stata software (version 13, StataCorp, College Station, USA). Data will be described by frequencies and percentages for categorical variables and by means and standard deviation (or median and interquartile range if data are not normally distributed) for continuous variables. The normality of continuous data will be assessed graphically and using the Shapiro-Wilk test. The main analysis will consist in determining patient profiles regarding their mobility. Clustering-type approaches (supervised or not) will be proposed: k-means, vector machine support, machine learning, factor analysis. For example, factor analyses on mixed data will allow the main components of mobility to be characterized. They can be followed by an ascending hierarchical classification in order to determine homogeneous groups of patients. These groups will be described and compared on the main criteria evaluated using standard statistical tests: chi2 test (or Fisher's exact test if applicable) for the categorical criteria and using an analysis of variance (or Kruskal-Wallis if data are not normally distributed) for continuous criteria. The main analysis will be broken down more specifically for each of the pathologies considered. In addition, the sensitivity to change will be assessed in each pathology and for each assessment criterion. The search for factors related to the evolution of the different criteria will be carried out using usual tests and mixed multivariate models (logistics for categorical / linear criteria for continuous criteria) considering the subject as a random effect, and adjusting on the time criteria (inclusion / follow-up) and the criteria highlighted in the univariate analyses and in light of the elements reported in the literature. A sensitivity analysis will be proposed in order to study the statistical nature of the missing data and to propose, if necessary, the most suitable method of imputing the data: multiple imputation, maximum bias or LOCF in the case of longitudinal data. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Chu Clermont Ferrand - 63003 - Clermont-Ferrand - France	Lise Laclautre	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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)

Critère de non inclusion

- 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.

NCT04375280 - Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort (EVALMOB)

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