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Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort

Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04375280
Acronym
EVALMOB
Enrollment
5000
Registered
2020-05-05
Start date
2020-08-27
Completion date
2035-08-26
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis of the Distal Arteries, Without Gangrene, Chronic Obstructive Pulmonary Disease, Unspecified, Joint Osteoarthritis, Obesity, Unspecified, Parkinson Disease

Keywords

Prevention, Mobility, Altered mobility, Risk factors, Chronic illness, Chronic pathologies, Physical capacities, Physical test, Activity limitations

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.

Interventions

OTHERDevelopment of a screening algorithm designed to determine a dysmobility profile in patients with chronic illness.

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.)

Sponsors

I-SITE Cap 20-25 project
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
dismobility score calculated from the results reported in secondary outcomesDay 0The 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

MeasureTime frameDescription
Weight (Kg).Day 0Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Height (cm).Day 0Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
Body fat percentage (%).Day 0Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
Waist circumference (cm).Day 0Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
Hip circumference (cm).Day 0Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Brachial circumference (cm).Day 0Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Calf circumference (cm).Day 0Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
Body Mass Index (Kg/m²).Day 0BMI will be calculated (weight in kilograms divided by height in meters squared).
Body compositionDay 0Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
T-score (DS).DAy 0\- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Z-score (DS).Day 0Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
Fat massDay 0Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Fat-free mass (%).Day 0: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Fat mas index (Kg/m²).Day 0Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Ratio of android to gynoid fat mass.Day 0Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
Visceral adipose tissue (Kg).Day 0Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Fat-free mass index (kg/m²).Day 0: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Daily carbohydrate intake (in g and as a percentage of total caloric intake).Day 0Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
Appendicular fat-free mass index (Kg/m²).Day 0Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Bone mass (Kg)Day 0\- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
Daily caloric intake (Kcal/24h).Day 0Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
Daily protein intake (in g and as a percentage of total caloric intake).Day 0Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
Daily fat intake (in g and as a percentage of total caloric intake).Day 0Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
Nutritional status assessmentDay 0Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
Risk of undernutrition.Day 0Risk of undernutrition will be assessed with the Brocker Questionnaire
Basic biology.Day 0: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).Day 0: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).Day 0\- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).Day 0Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).Day 0Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).Day 0Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).Day 0\- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).Day 0Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary hand grip strength (Kg).Day 0Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
Endurance coefficient of the quadriceps muscles at 180°/s.Day 0Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
Endurance coefficient of the hamstring muscles at 180°/s.Day 0Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
Functional ratioDay 0Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
Mixed ratioDay 0\- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
Maximum voluntary pinch strength (Kg).Day 0Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
Hip passive joint rangeDay 0Hip joint range will be measured with a medical goniometer.
Knee passive joint range.Day 0Knee joint range will be measured with a medical goniometer.
Ankle passive joint rangeDay 0Ankle joint range will be measured with a medical goniometer.
Lower and upper limb muscle power assessment (MRC)Day 0Lower and upper limb muscle power assessment will be performed by an experienced physician.
Statokinesigram surface area (mm²)Day 0Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
Stabilogram length (mm).Day 0Stabilogram length will be measured with the STATIPRO® static posturography platform
Maximal deflection (forward, backward left and right).Day 0Maximal deflection will be measured with the STATIPRO® static posturography platform.
Velocity variations (mm/s).Day 0: Velocity variations will be measured with the STATIPRO® static posturography platform.
: Romberg ratio according to sway areaDay 0Romberg ratio will be measured with the STATIPRO® static posturography platform.
Romberg ratio according to center of pressure path lengthDay 0Romberg ratio will be measured with the STATIPRO® static posturography platform.
: Plantar pressure ratio sway area.Day 0Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
Plantar pressure ratio length.Day 0Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
Walking velocity (cm/s).Day 0Walking velocity will be measured with the GAITRite® Electronic Walkway.
Cadence (steps/min).Day 0: Cadence will be measured with the GAITRite® Electronic Walkway.
Step length (left and right foot) (cm)DAy 0Step length will be measured with the GAITRite® Electronic Walkway.
Stride length (cm).Day 0Stride length will be measured with the GAITRite® Electronic Walkway.
Single support time left and right foot (s).Day 0Single support time will be measured with the GAITRite® Electronic Walkway.
Double support time (s).Day 0: Double support time will be measured with the GAITRite® Electronic Walkway.
Swing time (s).Day 0: Swing time will be measured with the GAITRite® Electronic Walkway.
Swing phase (as a % of walking cycle).DAy 0: Swing phase will be measured with the GAITRite® Electronic Walkway.
Threshold power (Watts).Day 0Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Stance phase (as a % of walking cycle).Day 0Stance phase will be measured with the GAITRite® Electronic Walkway.
Vo2max (maximal oxygen consumption) (mL/Kg/min).Day 0: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Maximum heart rate (bpm).Day 0Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Maximum power (Watts).Day 0Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Threshold heart rate (bpm).DAy 0Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Forced vital Capacity (L).Day 0: Forced vital Capacity will be measured with a spirometry test.
Forced Expiratory volume (L)Day 0Forced Expiratory volume will be measured with a spirometry test.
Tiffeneau ratio (%).Day 0Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
Ventilatory reserve (%).Day 0Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Physical activityDay 0Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
Functional capacity timed-up and goDay 0Functional capacity will be evaluated using the Timed-Up and Go test.
Functional capacity TDM6Day 0Functional capacity will be evaluated using the 6-minute walk test.
Functional capacity Five Times Sit to Stand test.Day 0Functional capacity will be evaluated using the Five Times Sit to Stand test.
Functional capacity SPPBDay 0Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
Functional capacity the mini-BESTest.Day 0Functional capacity will be evaluated using the mini-BESTest.
Functional capacity Berg Balance Scale.Day 0Functional capacity will be evaluated using the Berg Balance Scale.
Functional capacity 10-meter walk testDay 0Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
DyspneaDay 0Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
Perceived exertion before, during and after effortDAy 0Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
PainDay 0: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
Sarcopenia riskDay 0Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
Social insecurityDay 0Social insecurity will be evaluated with the EPICES Score Questionnaire.
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 profilesDay 0Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.
Quality of lifeDay 0Quality of life will be evaluated with the 36-Item Short Form Survey.
: Balance confidence in performing various activitiesDay 0Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
Functioning in regards to activities of daily living.Day 0Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
ExhaustionDay 0Exhaustion will be evaluated with the FACIT-F Questionnaire.
Patient's opinion about their knee and associated problemsDay 0: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Patient's opinion about their hip and associated problemsDay 0Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
Predicting discharge destination after total joint arthroplasty.Day 0: Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);
Physical function in myositis patientsDay 0Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
Quality of life in Parkinson's DiseaseDay 0Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
Actimetry.during 5 consecutive days after day 0Actimetry data (energy expenditure, number of steps, sedentary time, total physical activity, etc.) will be obtained with the WGT3X-BT Actigraph inertial sensor unit.
KinesiophobiaDay 0Kinesiophobia will be evaluated with the TAMPA Scale.

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026