Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Joint Osteoarthritis
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- dismobility score calculated from the results reported in secondary outcomes
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Man or woman aged 18 to
- •Patients with chronic pathology contributing to impaired mobility.
- •Volunteers who have given their written consent.
- •Affiliated to French health care system (for France)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
dismobility score calculated from the results reported in secondary outcomes
Time Frame: Year 5
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
Secondary Outcomes
- Body Mass Index (Kg/m²).(Year 5)
- Body composition(Year 5)
- Fat-free mass (%).(Year 5)
- Fat mas index (Kg/m²).(Year 5)
- Ratio of android to gynoid fat mass.(Year 5)
- 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)
- Brachial circumference (cm).(Year 5)
- Calf circumference (cm).(Year 5)
- Z-score (DS).(Year 5)
- Daily fat intake (in g and as a percentage of total caloric intake).(Year 5)
- Risk of undernutrition.(Year 5)
- Appendicular fat-free mass index (Kg/m²).(Year 5)
- Daily carbohydrate intake (in g and as a percentage of total caloric intake).(Year 5)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).(Year 5)
- Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).(Year 5)
- Functional ratio(Year 5)
- Mixed ratio(Year 5)
- Statokinesigram surface area (mm²)(Year 5)
- Physical activity(Year 5)
- Weight (Kg).(Year 5)
- Height (cm).(Year 5)
- Body fat percentage (%).(Year 5)
- T-score (DS).(Year 5)
- Visceral adipose tissue (Kg).(Year 5)
- Fat-free mass index (kg/m²).(Year 5)
- Bone mass (Kg)(Year 5)
- Endurance coefficient of the quadriceps muscles at 180°/s.(Year 5)
- Maximum voluntary pinch strength (Kg).(Year 5)
- Stabilogram length (mm).(Year 5)
- Vo2max (maximal oxygen consumption) (mL/Kg/min).(Year 5)
- Waist circumference (cm).(Year 5)
- Hip circumference (cm).(Year 5)
- Fat mass(Year 5)
- Basic biology.(Year 5)
- Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).(Year 5)
- Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).(Year 5)
- Maximum voluntary hand grip strength (Kg).(Year 5)
- Maximal deflection (forward, backward left and right).(Year 5)
- Plantar pressure ratio length.(Year 5)
- Double support time (s).(Year 5)
- Functional capacity TDM6(Year 5)
- Daily caloric intake (Kcal/24h).(Year 5)
- Daily protein intake (in g and as a percentage of total caloric intake).(Year 5)
- Nutritional status assessment(Year 5)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).(Year 5)
- Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).(Year 5)
- Endurance coefficient of the hamstring muscles at 180°/s.(Year 5)
- Knee passive joint range.(Year 5)
- : Plantar pressure ratio sway area.(Year 5)
- Threshold heart rate (bpm).(Year 5)
- Forced Expiratory volume (L)(Year 5)
- Functional capacity Berg Balance Scale.(Year 5)
- Functional capacity 10-meter walk test(Year 5)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).(Year 5)
- Hip passive joint range(Year 5)
- Ankle passive joint range(Year 5)
- Lower and upper limb muscle power assessment (MRC)(Year 5)
- Velocity variations (mm/s).(Year 5)
- Stride length (cm).(year 5)
- Forced vital Capacity (L).(Year 5)
- Functional capacity timed-up and go(Year 5)
- Functional capacity SPPB(Year 5)
- Perceived exertion before, during and after effort(Year 5)
- Sarcopenia risk(Year 5)
- Social insecurity(Year 5)
- Patient's opinion about their knee and associated problems(Year 5)
- Walking velocity (cm/s).(Year 5)
- Cadence (steps/min).(Year 5)
- Single support time left and right foot (s).(Year 5)
- Swing time (s).(Year 5)
- Stance phase (as a % of walking cycle).(Year 5)
- Maximum heart rate (bpm).(Year 5)
- Maximum power (Watts).(Year 5)
- Threshold power (Watts).(Year 5)
- Tiffeneau ratio (%).(Year 5)
- Ventilatory reserve (%).(Year 5)
- Dyspnea(Year 5)
- Kinesiophobia(Year 5)
- : Romberg ratio according to sway area(Year 5)
- Romberg ratio according to center of pressure path length(Year 5)
- Step length (left and right foot) (cm)(Year 5)
- Swing phase (as a % of walking cycle).(Year 5)
- Functional capacity Five Times Sit to Stand test.(Year 5)
- Functional capacity the mini-BESTest.(Year 5)
- Pain(Year 5)
- Functioning in regards to activities of daily living.(Year 5)
- Patient's opinion about their hip and associated problems(Year 5)
- Predicting discharge destination after total joint arthroplasty.(Month 6)
- Actimetry.(during 5 consecutive days after day 0)
- Quality of life(Year 5)
- Quality of life in Parkinson's Disease(Year 5)
- : Balance confidence in performing various activities(Year 5)
- Exhaustion(Year 5)
- Physical function in myositis patients(Year 5)