Clinical trial NCT04375280: Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Official title: Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Joint Osteoarthritis
Atherosclerosis of the Distal Arteries, Without Gangrene
Parkinson Disease
Chronic Obstructive Pulmonary Disease, Unspecified
Obesity, Unspecified
Keywords: Prevention
Mobility
Altered mobility
Risk factors
Chronic illness
Chronic pathologies
Physical capacities
Physical test
Activity limitations
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: I-SITE Cap 20-25 project
First posted: 2020-05-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

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.

Primary outcomes:
measure: dismobility score calculated from the results reported in secondary outcomes
timeFrame: Day 0
measure: dismobility score calculated from the results reported in secondary outcomes
timeFrame: Month 6
measure: dismobility score calculated from the results reported in secondary outcomes
timeFrame: Year 1
measure: dismobility score calculated from the results reported in secondary outcomes
timeFrame: Year 2
measure: dismobility score calculated from the results reported in secondary outcomes
timeFrame: Year 5
Secondary outcomes:
measure: 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
timeFrame: Day 0
measure: Weight (Kg).
timeFrame: Day 0
measure: Weight (Kg).
timeFrame: Month 6
measure: Weight (Kg).
timeFrame: Year 1
measure: Weight (Kg).
timeFrame: Year 2
measure: Weight (Kg).
timeFrame: Year 5
measure: Height (cm).
timeFrame: Day 0
measure: Height (cm).
timeFrame: Month 6
measure: Height (cm).
timeFrame: Year 1
measure: Height (cm).
timeFrame: Year 2
measure: Height (cm).
timeFrame: Year 5
measure: Body fat percentage (%).
timeFrame: Day 0
measure: Body fat percentage (%).
timeFrame: Month 6
measure: Body fat percentage (%).
timeFrame: Year 1
measure: Body fat percentage (%).
timeFrame: Year 2
measure: Body fat percentage (%).
timeFrame: Year 5
measure: Waist circumference (cm).
timeFrame: Day 0
measure: Waist circumference (cm).
timeFrame: Month 5
measure: Waist circumference (cm).
timeFrame: Year 1
measure: Waist circumference (cm).
timeFrame: Year 2
measure: Waist circumference (cm).
timeFrame: Year 5
measure: Hip circumference (cm).
timeFrame: Day 0
measure: Hip circumference (cm).
timeFrame: Month 6
measure: Hip circumference (cm).
timeFrame: Year 1
measure: Hip circumference (cm).
timeFrame: Year 2
measure: Hip circumference (cm).
timeFrame: Year 5
measure: Brachial circumference (cm).
timeFrame: Day 0
measure: Brachial circumference (cm).
timeFrame: Month 6
measure: Brachial circumference (cm).
timeFrame: Year 1
measure: Brachial circumference (cm).
timeFrame: Year 2
measure: Brachial circumference (cm).
timeFrame: Year 5
measure: Calf circumference (cm).
timeFrame: Day 0
measure: Calf circumference (cm).
timeFrame: Month 6
measure: Calf circumference (cm).
timeFrame: Year 1
measure: Calf circumference (cm).
timeFrame: Year 2
measure: Calf circumference (cm).
timeFrame: Year 5
measure: Body Mass Index (Kg/m²).
timeFrame: Day 0
measure: Body Mass Index (Kg/m²).
timeFrame: Month 6
measure: Body Mass Index (Kg/m²).
timeFrame: Year 1
measure: Body Mass Index (Kg/m²).
timeFrame: Year 2
measure: Body Mass Index (Kg/m²).
timeFrame: Year 5
measure: Body composition
timeFrame: Day 0
measure: Body composition
timeFrame: Month 6
measure: Body composition
timeFrame: Year 1
measure: Body composition
timeFrame: Year 2
measure: Body composition
timeFrame: Year 5
measure: T-score (DS).
timeFrame: DAy 0
measure: T-score (DS).
timeFrame: Month 6
measure: T-score (DS).
timeFrame: Year 1
measure: T-score (DS).
timeFrame: Year 2
measure: T-score (DS).
timeFrame: Year 5
measure: Z-score (DS).
timeFrame: Day 0
measure: Z-score (DS).
timeFrame: Month 6
measure: Z-score (DS).
timeFrame: Year 1
measure: Z-score (DS).
timeFrame: Year 2
measure: Z-score (DS).
timeFrame: Year 5
measure: Fat mass
timeFrame: Day 0
measure: Fat mass
timeFrame: Month 6
measure: Fat mass
timeFrame: Year 1
measure: Fat mass
timeFrame: Year 2
measure: Fat mass
timeFrame: Year 5
measure: Fat-free mass (%).
timeFrame: Day 0
measure: Fat-free mass (%).
timeFrame: Month 6
measure: Fat-free mass (%).
timeFrame: Year 1
measure: Fat-free mass (%).
timeFrame: Year 2
measure: Fat-free mass (%).
timeFrame: Year 5
measure: Fat mas index (Kg/m²).
timeFrame: Day 0
measure: Fat mas index (Kg/m²).
timeFrame: Month 6
measure: Fat mas index (Kg/m²).
timeFrame: Year 1
measure: Fat mas index (Kg/m²).
timeFrame: Year 2
measure: Fat mas index (Kg/m²).
timeFrame: Year 5
measure: Ratio of android to gynoid fat mass.
timeFrame: Day 0
measure: Ratio of android to gynoid fat mass.
timeFrame: Month 6
measure: Ratio of android to gynoid fat mass.
timeFrame: Year 1
measure: Ratio of android to gynoid fat mass.
timeFrame: Year 2
measure: Ratio of android to gynoid fat mass.
timeFrame: Year 5
measure: Visceral adipose tissue (Kg).
timeFrame: Day 0
measure: Visceral adipose tissue (Kg).
timeFrame: Month 6
measure: Visceral adipose tissue (Kg).
timeFrame: Year 1
measure: Visceral adipose tissue (Kg).
timeFrame: Year 2
measure: Visceral adipose tissue (Kg).
timeFrame: Year 5
measure: Fat-free mass index (kg/m²).
timeFrame: Day 0
measure: Fat-free mass index (kg/m²).
timeFrame: Month 6
measure: Fat-free mass index (kg/m²).
timeFrame: Year 1
measure: Fat-free mass index (kg/m²).
timeFrame: Year 2
measure: Fat-free mass index (kg/m²).
timeFrame: Year 5
measure: Appendicular fat-free mass index (Kg/m²).
timeFrame: Day 0
measure: Appendicular fat-free mass index (Kg/m²).
timeFrame: Month 6
measure: Appendicular fat-free mass index (Kg/m²).
timeFrame: Year 1
measure: Appendicular fat-free mass index (Kg/m²).
timeFrame: Year 2
measure: Appendicular fat-free mass index (Kg/m²).
timeFrame: Year 5
measure: Bone mass (Kg)
timeFrame: Day 0
measure: Bone mass (Kg)
timeFrame: Month 6
measure: Bone mass (Kg)
timeFrame: Year 1
measure: Bone mass (Kg)
timeFrame: Year 2
measure: Bone mass (Kg)
timeFrame: Year 5
measure: Daily caloric intake (Kcal/24h).
timeFrame: Day 0
measure: Daily caloric intake (Kcal/24h).
timeFrame: Month 6
measure: Daily caloric intake (Kcal/24h).
timeFrame: Year 1
measure: Daily caloric intake (Kcal/24h).
timeFrame: Year 2
measure: Daily caloric intake (Kcal/24h).
timeFrame: Year 5
measure: Daily protein intake (in g and as a percentage of total caloric intake).
timeFrame: Day 0
measure: Daily protein intake (in g and as a percentage of total caloric intake).
timeFrame: Month 6
measure: Daily protein intake (in g and as a percentage of total caloric intake).
timeFrame: Year 1
measure: Daily protein intake (in g and as a percentage of total caloric intake).
timeFrame: Year 2
measure: Daily protein intake (in g and as a percentage of total caloric intake).
timeFrame: Year 5
measure: Daily carbohydrate intake (in g and as a percentage of total caloric intake).
timeFrame: Day 0
measure: Daily carbohydrate intake (in g and as a percentage of total caloric intake).
timeFrame: Month 6
measure: Daily carbohydrate intake (in g and as a percentage of total caloric intake).
timeFrame: Year 1
measure: Daily carbohydrate intake (in g and as a percentage of total caloric intake).
timeFrame: Year 2
measure: Daily carbohydrate intake (in g and as a percentage of total caloric intake).
timeFrame: Year 5
measure: Daily fat intake (in g and as a percentage of total caloric intake).
timeFrame: Day 0
measure: Daily fat intake (in g and as a percentage of total caloric intake).
timeFrame: Month 6
measure: Daily fat intake (in g and as a percentage of total caloric intake).
timeFrame: Year 1
measure: Daily fat intake (in g and as a percentage of total caloric intake).
timeFrame: Year 2
measure: Daily fat intake (in g and as a percentage of total caloric intake).
timeFrame: Year 5
measure: Nutritional status assessment
timeFrame: Day 0
measure: Nutritional status assessment
timeFrame: Month 6
measure: Nutritional status assessment
timeFrame: Year 1
measure: Nutritional status assessment
timeFrame: Year 2
measure: Nutritional status assessment
timeFrame: Year 5
measure: Risk of undernutrition.
timeFrame: Day 0
measure: Risk of undernutrition.
timeFrame: Month 6
measure: Risk of undernutrition.
timeFrame: Year 1
measure: Risk of undernutrition.
timeFrame: Year 2
measure: Risk of undernutrition.
timeFrame: Year 5
measure: Basic biology.
timeFrame: Day 0
measure: Basic biology.
timeFrame: Month 6
measure: Basic biology.
timeFrame: Year 1
measure: Basic biology.
timeFrame: Year 2
measure: Basic biology.
timeFrame: Year 5
measure: Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
timeFrame: Day 0
measure: Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
timeFrame: Month 6
measure: Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
timeFrame: Year 1
measure: Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
timeFrame: Year 2
measure: Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
timeFrame: Year 5
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Day 0
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Month 6
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 1
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 2
measure: Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
timeFrame: Year 5
measure: Endurance coefficient of the quadriceps muscles at 180°/s.
timeFrame: Day 0
measure: Endurance coefficient of the quadriceps muscles at 180°/s.
timeFrame: Month 6
measure: Endurance coefficient of the quadriceps muscles at 180°/s.
timeFrame: Year 1
measure: Endurance coefficient of the quadriceps muscles at 180°/s.
timeFrame: Year 2
measure: Endurance coefficient of the quadriceps muscles at 180°/s.
timeFrame: Year 5
measure: Endurance coefficient of the hamstring muscles at 180°/s.
timeFrame: Day 0
measure: Endurance coefficient of the hamstring muscles at 180°/s.
timeFrame: Month 6
measure: Endurance coefficient of the hamstring muscles at 180°/s.
timeFrame: Year 1
measure: Endurance coefficient of the hamstring muscles at 180°/s.
timeFrame: Year 2
measure: Endurance coefficient of the hamstring muscles at 180°/s.
timeFrame: Year 5
measure: Functional ratio
timeFrame: Day 0
measure: Functional ratio
timeFrame: Month 6
measure: Functional ratio
timeFrame: Year 1
measure: Functional ratio
timeFrame: Year 2
measure: Functional ratio
timeFrame: Year 5
measure: Mixed ratio
timeFrame: Day 0
measure: Mixed ratio
timeFrame: Month 6
measure: Mixed ratio
timeFrame: Year 1
measure: Mixed ratio
timeFrame: Year 2
measure: Mixed ratio
timeFrame: Year 5
measure: Maximum voluntary hand grip strength (Kg).
timeFrame: Day 0
measure: Maximum voluntary hand grip strength (Kg).
timeFrame: Month 6
measure: Maximum voluntary hand grip strength (Kg).
timeFrame: Year 1
measure: Maximum voluntary hand grip strength (Kg).
timeFrame: Year 2
measure: Maximum voluntary hand grip strength (Kg).
timeFrame: Year 5
measure: Maximum voluntary pinch strength (Kg).
timeFrame: Day 0
measure: Maximum voluntary pinch strength (Kg).
timeFrame: Month 6
measure: Maximum voluntary pinch strength (Kg).
timeFrame: Year 1
measure: Maximum voluntary pinch strength (Kg).
timeFrame: Year 2
measure: Maximum voluntary pinch strength (Kg).
timeFrame: Year 5
measure: Hip passive joint range
timeFrame: Day 0
measure: Hip passive joint range
timeFrame: Month 6
measure: Hip passive joint range
timeFrame: Year 1
measure: Hip passive joint range
timeFrame: Year 2
measure: Hip passive joint range
timeFrame: Year 5
measure: Knee passive joint range.
timeFrame: Day 0
measure: Knee passive joint range.
timeFrame: Month 6
measure: Knee passive joint range.
timeFrame: Year 1
measure: Knee passive joint range.
timeFrame: Year 2
measure: Knee passive joint range.
timeFrame: Year 5
measure: Ankle passive joint range
timeFrame: Day 0
measure: Ankle passive joint range
timeFrame: Month 6
measure: Ankle passive joint range
timeFrame: Year 1
measure: Ankle passive joint range
timeFrame: Year 2
measure: Ankle passive joint range
timeFrame: Year 5
measure: Lower and upper limb muscle power assessment (MRC)
timeFrame: Day 0
measure: Lower and upper limb muscle power assessment (MRC)
timeFrame: Month 6
measure: Lower and upper limb muscle power assessment (MRC)
timeFrame: Year 1
measure: Lower and upper limb muscle power assessment (MRC)
timeFrame: Year 2
measure: Lower and upper limb muscle power assessment (MRC)
timeFrame: Year 5
measure: Statokinesigram surface area (mm²)
timeFrame: Day 0
measure: Statokinesigram surface area (mm²)
timeFrame: Month 6
measure: Statokinesigram surface area (mm²)
timeFrame: Year 1
measure: Statokinesigram surface area (mm²)
timeFrame: Year 2
measure: Statokinesigram surface area (mm²)
timeFrame: Year 5
measure: Stabilogram length (mm).
timeFrame: Day 0
measure: Stabilogram length (mm).
timeFrame: Month 6
measure: Stabilogram length (mm).
timeFrame: Year 1
measure: Stabilogram length (mm).
timeFrame: Year 2
measure: Stabilogram length (mm).
timeFrame: Year 5
measure: Maximal deflection (forward, backward left and right).
timeFrame: Day 0
measure: Maximal deflection (forward, backward left and right).
timeFrame: Month 6
measure: Maximal deflection (forward, backward left and right).
timeFrame: Year 1
measure: Maximal deflection (forward, backward left and right).
timeFrame: Year 2
measure: Maximal deflection (forward, backward left and right).
timeFrame: Year 5
measure: Velocity variations (mm/s).
timeFrame: Day 0
measure: Velocity variations (mm/s).
timeFrame: Month 6
measure: Velocity variations (mm/s).
timeFrame: Year 1
measure: Velocity variations (mm/s).
timeFrame: Year 2
measure: Velocity variations (mm/s).
timeFrame: Year 5
measure: : Romberg ratio according to sway area
timeFrame: Day 0
measure: : Romberg ratio according to sway area
timeFrame: Month 6
measure: : Romberg ratio according to sway area
timeFrame: Year 1
measure: : Romberg ratio according to sway area
timeFrame: Year 2
measure: : Romberg ratio according to sway area
timeFrame: Year 5
measure: Romberg ratio according to center of pressure path length
timeFrame: Day 0
measure: Romberg ratio according to center of pressure path length
timeFrame: Month 6
measure: Romberg ratio according to center of pressure path length
timeFrame: Year 1
measure: Romberg ratio according to center of pressure path length
timeFrame: Year 2
measure: Romberg ratio according to center of pressure path length
timeFrame: Year 5
measure: : Plantar pressure ratio sway area.
timeFrame: Day 0
measure: : Plantar pressure ratio sway area.
timeFrame: Month 6
measure: : Plantar pressure ratio sway area.
timeFrame: Year 1
measure: : Plantar pressure ratio sway area.
timeFrame: Year 2
measure: : Plantar pressure ratio sway area.
timeFrame: Year 5
measure: Plantar pressure ratio length.
timeFrame: Day 0
measure: Plantar pressure ratio length.
timeFrame: Month 6
measure: Plantar pressure ratio length.
timeFrame: Year 1
measure: Plantar pressure ratio length.
timeFrame: Year 2
measure: Plantar pressure ratio length.
timeFrame: Year 5
measure: Walking velocity (cm/s).
timeFrame: Day 0
measure: Walking velocity (cm/s).
timeFrame: Month 6
measure: Walking velocity (cm/s).
timeFrame: Year 1
measure: Walking velocity (cm/s).
timeFrame: Year 2
measure: Walking velocity (cm/s).
timeFrame: Year 5
measure: Cadence (steps/min).
timeFrame: Day 0
measure: Cadence (steps/min).
timeFrame: Month 6
measure: Cadence (steps/min).
timeFrame: Year 1
measure: Cadence (steps/min).
timeFrame: Year 2
measure: Cadence (steps/min).
timeFrame: Year 5
measure: Step length (left and right foot) (cm)
timeFrame: DAy 0
measure: Step length (left and right foot) (cm)
timeFrame: Month 6
measure: Step length (left and right foot) (cm)
timeFrame: Year 1
measure: Step length (left and right foot) (cm)
timeFrame: Year 2
measure: Step length (left and right foot) (cm)
timeFrame: Year 5
measure: Stride length (cm).
timeFrame: Day 0
measure: Stride length (cm).
timeFrame: month 6
measure: Stride length (cm).
timeFrame: year 1
measure: Stride length (cm).
timeFrame: year 2
measure: Stride length (cm).
timeFrame: year 5
measure: Single support time left and right foot (s).
timeFrame: Day 0
measure: Single support time left and right foot (s).
timeFrame: Month 6
measure: Single support time left and right foot (s).
timeFrame: Year 1
measure: Single support time left and right foot (s).
timeFrame: Year 2
measure: Single support time left and right foot (s).
timeFrame: Year 5
measure: Double support time (s).
timeFrame: Day 0
measure: Double support time (s).
timeFrame: Month 6
measure: Double support time (s).
timeFrame: YEar 1
measure: Double support time (s).
timeFrame: Year 2
measure: Double support time (s).
timeFrame: Year 5
measure: Swing time (s).
timeFrame: Day 0
measure: Swing time (s).
timeFrame: Month 6
measure: Swing time (s).
timeFrame: Year 1
measure: Swing time (s).
timeFrame: Year 2
measure: Swing time (s).
timeFrame: Year 5
measure: Swing phase (as a % of walking cycle).
timeFrame: DAy 0
measure: Swing phase (as a % of walking cycle).
timeFrame: Month 6
measure: Swing phase (as a % of walking cycle).
timeFrame: Year 1
measure: Swing phase (as a % of walking cycle).
timeFrame: Year 2
measure: Swing phase (as a % of walking cycle).
timeFrame: Year 5
measure: Stance phase (as a % of walking cycle).
timeFrame: Day 0
measure: Stance phase (as a % of walking cycle).
timeFrame: Month 6
measure: Stance phase (as a % of walking cycle).
timeFrame: Year 1
measure: Stance phase (as a % of walking cycle).
timeFrame: Year 2
measure: Stance phase (as a % of walking cycle).
timeFrame: Year 5
measure: Vo2max (maximal oxygen consumption) (mL/Kg/min).
timeFrame: Day 0
measure: Vo2max (maximal oxygen consumption) (mL/Kg/min).
timeFrame: Month 6
measure: Vo2max (maximal oxygen consumption) (mL/Kg/min).
timeFrame: Year 1
measure: Vo2max (maximal oxygen consumption) (mL/Kg/min).
timeFrame: Year 2
measure: Vo2max (maximal oxygen consumption) (mL/Kg/min).
timeFrame: Year 5
measure: Maximum heart rate (bpm).
timeFrame: Day 0
measure: Maximum heart rate (bpm).
timeFrame: Month 6
measure: Maximum heart rate (bpm).
timeFrame: Year 1
measure: Maximum heart rate (bpm).
timeFrame: Year 2
measure: Maximum heart rate (bpm).
timeFrame: Year 5
measure: Maximum power (Watts).
timeFrame: Day 0
measure: Maximum power (Watts).
timeFrame: Month 6
measure: Maximum power (Watts).
timeFrame: Year 1
measure: Maximum power (Watts).
timeFrame: Year 2
measure: Maximum power (Watts).
timeFrame: Year 5
measure: Threshold power (Watts).
timeFrame: Day 0
measure: Threshold power (Watts).
timeFrame: Month 6
measure: Threshold power (Watts).
timeFrame: Year 1
measure: Threshold power (Watts).
timeFrame: Year 2
measure: Threshold power (Watts).
timeFrame: Year 5
measure: Threshold heart rate (bpm).
timeFrame: DAy 0
measure: Threshold heart rate (bpm).
timeFrame: Month 6
measure: Threshold heart rate (bpm).
timeFrame: Year 1
measure: Threshold heart rate (bpm).
timeFrame: Year 2
measure: Threshold heart rate (bpm).
timeFrame: Year 5
measure: Forced vital Capacity (L).
timeFrame: Day 0
measure: Forced vital Capacity (L).
timeFrame: Month 6
measure: Forced vital Capacity (L).
timeFrame: Year 1
measure: Forced vital Capacity (L).
timeFrame: Year 2
measure: Forced vital Capacity (L).
timeFrame: Year 5
measure: Forced Expiratory volume (L)
timeFrame: Day 0
measure: Forced Expiratory volume (L)
timeFrame: Month 6
measure: Forced Expiratory volume (L)
timeFrame: Year 1
measure: Forced Expiratory volume (L)
timeFrame: Year 2
measure: Forced Expiratory volume (L)
timeFrame: Year 5
measure: Tiffeneau ratio (%).
timeFrame: Day 0
measure: Tiffeneau ratio (%).
timeFrame: Month 6
measure: Tiffeneau ratio (%).
timeFrame: Year 1
measure: Tiffeneau ratio (%).
timeFrame: Year 2
measure: Tiffeneau ratio (%).
timeFrame: Year 5
measure: Ventilatory reserve (%).
timeFrame: Day 0
measure: Ventilatory reserve (%).
timeFrame: Month 6
measure: Ventilatory reserve (%).
timeFrame: Year 1
measure: Ventilatory reserve (%).
timeFrame: Year 2
measure: Ventilatory reserve (%).
timeFrame: Year 5
measure: Physical activity
timeFrame: Day 0
measure: Physical activity
timeFrame: Month 6
measure: Physical activity
timeFrame: Year 1
measure: Physical activity
timeFrame: Year 2
measure: Physical activity
timeFrame: Year 5
measure: Functional capacity timed-up and go
timeFrame: Day 0
measure: Functional capacity timed-up and go
timeFrame: Month 6
measure: Functional capacity timed-up and go
timeFrame: Year 1
measure: Functional capacity timed-up and go
timeFrame: Year 2
measure: Functional capacity timed-up and go
timeFrame: Year 5
measure: Functional capacity TDM6
timeFrame: Day 0
measure: Functional capacity TDM6
timeFrame: Month 6
measure: Functional capacity TDM6
timeFrame: Year 1
measure: Functional capacity TDM6
timeFrame: Year 2
measure: Functional capacity TDM6
timeFrame: Year 5
measure: Functional capacity Five Times Sit to Stand test.
timeFrame: Day 0
measure: Functional capacity Five Times Sit to Stand test.
timeFrame: Month 6
measure: Functional capacity Five Times Sit to Stand test.
timeFrame: Year 1
measure: Functional capacity Five Times Sit to Stand test.
timeFrame: Year 2
measure: Functional capacity Five Times Sit to Stand test.
timeFrame: Year 5
measure: Functional capacity SPPB
timeFrame: Day 0
measure: Functional capacity SPPB
timeFrame: Month 6
measure: Functional capacity SPPB
timeFrame: Year 1
measure: Functional capacity SPPB
timeFrame: Year 2
measure: Functional capacity SPPB
timeFrame: Year 5
measure: Functional capacity the mini-BESTest.
timeFrame: Day 0
measure: Functional capacity the mini-BESTest.
timeFrame: Month 6
measure: Functional capacity the mini-BESTest.
timeFrame: Year 1
measure: Functional capacity the mini-BESTest.
timeFrame: Year 2
measure: Functional capacity the mini-BESTest.
timeFrame: Year 5
measure: Functional capacity Berg Balance Scale.
timeFrame: Day 0
measure: Functional capacity Berg Balance Scale.
timeFrame: Month 6
measure: Functional capacity Berg Balance Scale.
timeFrame: Year 1
measure: Functional capacity Berg Balance Scale.
timeFrame: Year 2
measure: Functional capacity Berg Balance Scale.
timeFrame: Year 5
measure: Functional capacity 10-meter walk test
timeFrame: Day 0
measure: Functional capacity 10-meter walk test
timeFrame: Month 6
measure: Functional capacity 10-meter walk test
timeFrame: Year 1
measure: Functional capacity 10-meter walk test
timeFrame: Year 2
measure: Functional capacity 10-meter walk test
timeFrame: Year 5
measure: Dyspnea
timeFrame: Day 0
measure: Dyspnea
timeFrame: Month 6
measure: Dyspnea
timeFrame: Year 1
measure: Dyspnea
timeFrame: Year 2
measure: Dyspnea
timeFrame: Year 5
measure: Perceived exertion before, during and after effort
timeFrame: DAy 0
measure: Perceived exertion before, during and after effort
timeFrame: Month 6
measure: Perceived exertion before, during and after effort
timeFrame: Year 1
measure: Perceived exertion before, during and after effort
timeFrame: Year 2
measure: Perceived exertion before, during and after effort
timeFrame: Year 5
measure: Pain
timeFrame: Day 0
measure: Pain
timeFrame: Month 6
measure: Pain
timeFrame: Year 1
measure: Pain
timeFrame: Year 2
measure: Pain
timeFrame: Year 5
measure: Sarcopenia risk
timeFrame: Day 0
measure: Sarcopenia risk
timeFrame: Month 6
measure: Sarcopenia risk
timeFrame: Year 1
measure: Sarcopenia risk
timeFrame: Year 2
measure: Sarcopenia risk
timeFrame: Year 5
measure: Social insecurity
timeFrame: Day 0
measure: Social insecurity
timeFrame: Month 6
measure: Social insecurity
timeFrame: Year 1
measure: Social insecurity
timeFrame: Year 2
measure: Social insecurity
timeFrame: Year 5
measure: Kinesiophobia
timeFrame: Day 0
measure: Kinesiophobia
timeFrame: Month 6
measure: Kinesiophobia
timeFrame: Year 1
measure: Kinesiophobia
timeFrame: Year 2
measure: Kinesiophobia
timeFrame: Year 5
measure: Quality of life
timeFrame: Day 0
measure: Quality of life
timeFrame: Month 6
measure: Quality of life
timeFrame: Year 1
measure: Quality of life
timeFrame: Year 2
measure: Quality of life
timeFrame: Year 5
measure: : Balance confidence in performing various activities
timeFrame: Day 0
measure: : Balance confidence in performing various activities
timeFrame: Month 6
measure: : Balance confidence in performing various activities
timeFrame: Year 1
measure: : Balance confidence in performing various activities
timeFrame: Year 2
measure: : Balance confidence in performing various activities
timeFrame: Year 5
measure: Functioning in regards to activities of daily living.
timeFrame: Day 0
measure: Functioning in regards to activities of daily living.
timeFrame: Month 6
measure: Functioning in regards to activities of daily living.
timeFrame: Year 1
measure: Functioning in regards to activities of daily living.
timeFrame: Year 2
measure: Functioning in regards to activities of daily living.
timeFrame: Year 5
measure: Exhaustion
timeFrame: Day 0
measure: Exhaustion
timeFrame: Month 6
measure: Exhaustion
timeFrame: Year 1
measure: Exhaustion
timeFrame: Year 2
measure: Exhaustion
timeFrame: Year 5
measure: Patient's opinion about their knee and associated problems
timeFrame: Day 0
measure: Patient's opinion about their knee and associated problems
timeFrame: Month 6
measure: Patient's opinion about their knee and associated problems
timeFrame: Year 1
measure: Patient's opinion about their knee and associated problems
timeFrame: Year 2
measure: Patient's opinion about their knee and associated problems
timeFrame: Year 5
measure: Patient's opinion about their hip and associated problems
timeFrame: Day 0
measure: Patient's opinion about their hip and associated problems
timeFrame: Month 6
measure: Patient's opinion about their hip and associated problems
timeFrame: Year 1
measure: Patient's opinion about their hip and associated problems
timeFrame: Year 2
measure: Patient's opinion about their hip and associated problems
timeFrame: Year 5
measure: Predicting discharge destination after total joint arthroplasty.
timeFrame: Day 0
measure: Predicting discharge destination after total joint arthroplasty.
timeFrame: Month 6
measure: Physical function in myositis patients
timeFrame: Day 0
measure: Physical function in myositis patients
timeFrame: Month 6
measure: Physical function in myositis patients
timeFrame: Year 1
measure: Physical function in myositis patients
timeFrame: Year 2
measure: Physical function in myositis patients
timeFrame: Year 5
measure: Quality of life in Parkinson's Disease
timeFrame: Day 0
measure: Quality of life in Parkinson's Disease
timeFrame: Month 6
measure: Quality of life in Parkinson's Disease
timeFrame: Year 1
measure: Quality of life in Parkinson's Disease
timeFrame: Year 2
measure: Quality of life in Parkinson's Disease
timeFrame: Year 5
measure: Actimetry.
timeFrame: during 5 consecutive days after day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Costes
role: PRINCIPAL_INVESTIGATOR
References: