Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects.
Conditions: Obesity
Sponsor: Hopital Forcilles

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Study of the association between peripheral muscle function and quality of 
life in subjects with obesity. 
OVALIA
Version n°2 of 17/02/2022
Protocol 
code 
number
RCB ID NO.
PPC NUMBER
CNIL or MR 
number
No. Clinical 
Trial
2021-12-1
2021-A03248-33
22.00131.000100
MR001
<...>
Interventional research involving humans with minimal risk and minimal burden (Type 
2 HIPR)
PRINCIPAL INVESTIGATOR
Sophie Vidal-Jessel, Internist specialized in nutrition, Forcilles Hospital, Diabetes and Obesity Service
CO-INVESTIGATORS
Andreia GOMES LOPES, Physiotherapist, Forcilles 
Hospital, Diabetes-Obesity SSR Department 
Carlos DIAZ LOPEZ, physiotherapist, Forcilles 
Hospital, rehabilitation department
Aymeric LE NEINDRE, physiotherapist, doctor of science
Forcilles Hospital, Clinical Research Office
METHODOLOGY-STATISTICS
Aymeric LE NEINDRE, Ph.D., Clinical Research Office
Sponsor:
Forcilles Hospital-Cognacq-Jay Foundation
Route de Servon
77150 Férolles-Attilly
Contact:
Aymeric LE NEINDRE, clinical research coordinator
Tel: 01 60 64 60 93
Mail: aleneindre@cognacq-jay.fr 

 
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MAIN CORRESPONDENTS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Sophie VIDAL-JESSEL 
Principal 
Investigator 
Physician  
svidaljessel@cognacq-jay.fr 
01.60.64.61.62 
Andreia GOMES LOPES  
Co-investigator 
Physiotherapist 
alopes@cognacq-jay.fr 
Aymeric LE NEINDRE 
Co-investigator 
Clinical 
Research 
Coordinator 
aleneindre@cognacq-jay.fr 
0160646093 
Carlos DIAZ LOPEZ  
Co-investigator 
Physiotherapist 
cdiazlopez@cognacq-jay.fr  
0160646130 
  
 

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PROTOCOL VERSION HISTORY
 
Version
Date
Reason for the change
2
17/02/2022
Requests for changes to 
the PPC  
 
 
 

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RESEARCH SUMMARY
Manager 
Forcilles Hospital-Cognacq-Jay Foundation 
Person who 
directs and 
monitors the 
research 
Andreia GOMES LOPES 
Title 
Study of the association of peripheral muscle function and quality of life in 
obese subjects. 
Acronym 
OVALIA 
Protocol version 
n°2 of 17/02/2022 
Rationale / 
context 
Assessment of health status and physical function is fundamental in 
patients with obesity, as they play an important role among the various 
factors influencing quality of life in this population (1). Several studies have 
shown an association between high BMI values and a significant 
deterioration in quality of life, especially in women (1). Excess body fat in 
obese patients seems to be responsible for muscle atrophy. This causal 
link is probably related to dysfunctions in adipose tissue, leading to a 
decrease in the expression of proteins responsible for muscle contraction 
(2). Recent literature highlights an alteration in quality of life, particularly 
in obese and elderly subjects, for which changes in muscle function are 
partly responsible. Changes in muscle function can be assessed by 
simple, rapid and non-invasive tools. They could allow the identification of 
obese subjects at risk of at risk of muscle atrophy, stratify the risk, and 
propose the implementation of a prophylactic intervention or an early 
management.  
Main Objective 
The main objective of this study is to evaluate the association between 
structural alteration of the quadriceps and quality of life in obese patients.
Secondary 
objectives 
Secondary objectives are to assess: 
- 
The association between quadriceps thickness and quality of life; 
- 
The association between grip strength and quality of life; 
- 
The association between quadriceps strength of the quadriceps and 
quality of life; 

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-
The association between quadriceps strength and ultrasound 
measurements of the quadriceps. 
Research 
Diagram 
Prospective, monocentric, interventional cohort study with minimal risks 
and constraints falling within the scope of article L.1121-1 of the Public 
Health Code. 
Inclusion criteria
- 
Obese patient (BMI > 30) consulting a Nutrition Day Hospital (HDJ); 
- 
Patient at least 18 years of age at the time of inclusion; 
- 
Affiliation with a social security system or beneficiary of such a system 
; 
- 
Oral, free, informed and express consent of the patient. 
Non-inclusion 
criteria 
- 
Patient refusal to participate in the study; 
- 
Known pregnancy; 
- 
State of Consciousness Incompatible with Obtaining Consent; 
- 
Person subject to a safeguard of justice measure ; 
- 
Patient under guardianship or curatorship. 
Primary 
endpoint 
The primary endpoint was the association between femoral rectus muscle 
echogenicity and the SF-36 quality of life score. 
Secondary 
endpoints 
The secondary evaluation criteria will be: 
- 
The association between ultrasound thickness of the femoral rectus 
and the SF-36 quality of life score; 
- 
The association between grip strength measured by the handgrip and 
the SF-36 quality of life score; 
- 
The association between quadriceps Voluntary Maximum Strength 
(VMS) on dynamometry and SF-36 quality of life score; 
- 
The association between quadriceps FMV with dynamometry and 
ultrasound 
measurements 
of the 
rectus femoris 
(thickness, 
echogenicity, and cross-sectional area). 
Intervention 
Patients will be clinically assessed for muscle function: FMV and handgrip. 
A muscle ultrasound and a quality of life score will also be performed in 
the included patients. 
Number of 
subjects needed 
84 

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Expected 
number of 
centers 
1 
Duration of the 
research 
9 months 
Statistical 
analysis of the 
data 
Statistics will be primarily descriptive and will be based on means (+/-
standard deviation) or medians [minimum-maximum] depending on the 
distribution of quantitative variables. Qualitative variables will be described 
in terms of numbers and percentages. Univariate comparisons will use the 
usual statistical tests after verification of the distribution of the variables 
(Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents 
Wilcoxon and Kruskal-Wallis tests). 
Tests will be performed at the 5% significance level. The 95% confidence 
intervals will be provided for each estimate. Measures of association 
between categorical variables will be performed using the Chi-square or 
Fisher test depending on the distribution of the data.  Calculations will be 
done using SPSS v21 IBM and R software (version 3.6.1, www.R-
project.org).  
Expected 
benefits 
This study will evaluate the association between peripheral muscle 
function and quality of life impairment in obese patients hospitalized in 
HDJ Nutrition.  These results will confirm the association between muscle 
status and quality of life in obese patients, which is not yet clear in the 
scientific literature. If necessary, these results will make it possible to 
propose non-invasive and inexpensive tools to screen for muscle damage 
in this patient population. This screening could allow to propose early 
management programs. 
Source of 
funding 
Forcilles Hospital-Cognacq-Jay Foundation 
Independent 
Supervisory 
Committee 
planned 
No 
 
 

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LIST OF ABBREVIATIONS
 
AVQ's
Activities of daily living 
GMF
Maximum voluntary force 
HDJ
Day Hospital 
BMI
Body mass index  
mCSA
"Muscle Cross-Sectional Area 
WHO
World Health Organization 
 
 
 

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Table of contents 
1 
Rationale for the research 
11 
1.1 
Obesity, a global public health issue 
11 
1.2 
Functional consequences of obesity 
11 
1.2.1 
Quality of life 
11 
1.2.2 
Peripheral muscle damage 
12 
1.3 
Ultrasound of the peripheral muscle 
13 
2 
Originality of the research 
14 
3 
Research hypothesis 
14 
4 
Objective 
15 
4.1 
Main objective 
15 
4.2 
Secondary objectives 
15 
5 
Judging criteria 
15 
5.1 
Primary endpoint 
15 
5.2 
Secondary endpoint 
15 
5.3 
Inclusion criteria 
16 
5.4 
Non-inclusion criteria 
16 
5.5 
Recruitment procedures 
16 
6 
Research design 
16 
6.1 
Type of study 
16 
6.2 
Research Diagram 
17 
6.3 
Anticipated research schedule 
17 
6.4 
Location of the study 
17 
7 
Description of the usual care in HDJ Nutrition 
17 
7.1 
Description of the usual course of care 
17 
7.2 
Standard evaluation procedures 
18 
7.2.1 
Grip force (Hand Grip) 
18 
7.2.2 
Maximum Voluntary Force (MVF) of the quadriceps 
18 
8 
Evaluation procedures added by research 
19 
8.1 
Muscle ultrasound 
19 
8.1.1 
Operator training 
19 

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8.1.2
Realization of the measure
19
8.2 
Quality of Life Scale 
20 
9 
Conduct of the research 
20 
9.1 
Pre-inclusion visit 
20 
9.1.1 
Verification of inclusion and non-inclusion criteria 
20 
9.1.2 
Patient information and consent 
20 
9.2 
Inclusion visit 
21 
9.3 
Physiotherapist's visit 
21 
9.4 
End of research visit 
21 
9.5 
Summary table 
22 
10 
Statistical aspects 
23 
10.1 
Calculation of study size 
23 
10.2 
General aspects 
23 
11 
Expected results in terms of scientific and professional advances 
24 
12 
Expected benefits and risks for patients 
24 
12.1 
Minimal risks and constraints added by the research 
24 
12.2 
Expected benefits for the patient 
24 
13 
Feasibility 
24 
14 
Ethical and regulatory aspects 
25 
14.1 
Role of the promoter 
25 
14.2 
Submission to PPC 
25 
14.3 
Data protection 
26 
14.4 
Insurance 
26 
14.5 
Substantial amendment to the protocol 
27 
14.6 
Disclosure and Express Consent 
27 
14.7 
Expected time of publication of results in an international journal 
27 
14.8 
Data management 
28 
14.9 
Human and financial resources 
28 
14.10 
Data properties 
28 
15 
Bibliographic References 
29 
16 
APPENDICES 
31 

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16.1
Appendix 1: SF-36 Quality of Life Score
31
16.2 
Appendix 2: Handgrip Usage Protocol 
35 
16.3 
Appendix 3: Maximum Voluntary Force (MVF) of the quadriceps 
36 
16.4 
Appendix 4: Muscle Ultrasound Procedure 
37 
16.5 
Appendix 5: Patient Information Note 
40 
16.6 
Appendix 6: Katz ADL (Activities in Daily Living) Scale 
45 
16.7 
Appendix 7: Hospital Anxiety and Depression Scale 
46 
17 
List of investigators 
49 
 
 
 

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1 Rationale for the research
1.1 Obesity, a global public health issue 
Obesity is a disease characterized by an excessive and abnormal accumulation of body fat, 
associated with adverse health effects. Obesity has become a global public health problem 
and is responsible, according to the World Health Organization (WHO), for at least 2.8 million 
deaths (3) and is recognized as the fifth leading cause of death in the world. The number of 
obesity cases has almost tripled since 1975. 
In France, obesity affects 17% of adults and, among children, 16% of boys and 18% of girls 
(4). In parallel with the progression of obesity at the global level, the WHO declared in 2014 
the risk of the accumulation of diseases, including the coexistence of undernutrition and 
obesity.  
Obesity is a disease of multifactorial origin, linked to nutritional alterations, genetic, 
psychological, socio-economic factors and more sedentary behaviors (4) (5). The prevalence 
of obesity continues to increase in all age groups and in all socioeconomic groups. It is a major 
risk factor for a range of diseases, including type 2 diabetes, cardiovascular disease and 
certain types of cancer (6). People with obesity also have impaired health-related quality of 
life and higher mortality compared to healthy people (7). Excess adipose tissue has 
implications for physical disability, including changes in gait pattern and/or decreased 
functional capacity (8). These repercussions may be of peripheral muscular origin, with 
consequences for mobility and independence in activities of daily living (ADL's) (9). 
 
1.2 Functional consequences of obesity 
1.2.1 Quality of life 
The impact of obesity on quality of life has been assessed by several studies. According to 
the WHO, quality of life is how individuals perceive their position in life, in the context of the 
culture and value system in which they live and in relation to their goals, expectations, norms 
and concerns. It is a broad concept, incorporating in complex ways a person's physical health, 
psychological state, degree of independence, social relationships, personal beliefs, and 
relationship with important elements of the environment (10) (11). 
The assessment of health status and physical function is fundamental in patients with obesity, 
as they play a major role among the various factors that will influence their quality of life (1). 
Several studies have shown an association between high BMI values and a significant 
deterioration in quality of life, especially in women, mainly related to an increase in pain. In 

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addition, people with obesity have been identified as being more likely to suffer from 
depression and/or mood disorders (1).  
According to Kim et al. (2020) patients with obesity with or without a metabolic disorder have 
health alterations including mental problems and decreased quality of life (12). In younger 
obese subjects we also observe a decrease in quality of life compared to normal weight 
subjects, where muscle capacity may be a potential factor associated with impaired quality of 
life (13). 
 
1.2.2 Peripheral muscle damage 
Obese individuals have greater muscle mass and higher muscle strength than non-obese 
individuals. However, this increase in muscle strength is not proportional to the increase in 
total body mass, so that body weight-adjusted strength is lower in obese individuals than in 
nonobese adults (14). The increase in muscle mass in obese individuals results from the 
increased load imposed by body weight, which acts as a chronic stimulus to muscle tissue 
(15). Contrary to the benefits of resistance exercise, excess body fat does not appear to be a 
sufficient load stimulus to alleviate the functional consequences of obesity (difficulty walking, 
cycling, standing from a chair) (16).  
In addition, a decrease in the specific force of the muscle is observed in obese subjects, i.e. a 
decrease in the force related to the sectional area. There is therefore probably a structural 
alteration of the muscle in the obese patient, which has not yet been well described in the 
literature (17). The quantity of muscle fibers decreases and is replaced by infiltration of 
adipose and fibrous tissue. (17). This replacement of skeletal muscle fibers decreases muscle 
quality and increases density, thus altering its function. The reduction in muscle mass relative 
to fat mass, results in a relative loss of muscle strength available to support and move body 
weight (17). In elderly subjects with obesity the amount of fat mass is strongly and negatively 
correlated with leg extension strength (r = -0.825) (18)with a negative impact on physical 
functioning and quality of life (19). 
Moreover, an alteration in muscle contractile proteins coexists or occurs in a second stage in 
obese subjects, which can lead to muscle atrophy. Indeed, the expression of inflammation 
factors (IL-6 and IL-1b) by adipocytes leads to a decrease in the expression of genes coding 
for muscle contraction proteins, including troponin, titin and myosin (20). 
The association between lower limb function, including walking ability, and health-related 
quality of life has been studied in young subjects with obesity, finding that a decrease in this 
ability correlates with impaired quality of life (13).  
 

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1.3 Ultrasound of the peripheral muscle 
Muscle ultrasound measurements have become increasingly used as a noninvasive method 
to determine muscle characteristics (21). Muscle characteristics, particularly muscle size and 
quality, have been shown to be related to muscle strength and power as well as cardiovascular 
performance. Ultrasound can also measure muscle echogenicity. The echogenicity of a B-
mode (2D) ultrasound image is expressed by a gray scale (22). On an ultrasound image, the 
muscle bundles are hypoechoic areas, whereas the aponeuroses are hyperechoic. In the case 
of atrophied muscles, represented by hyperechoic structures, there is a decrease in the ability 
of ultrasound to penetrate deep into the tissue (23). Thus, the replacement of skeletal muscle 
fibers by fatty infiltrates decreases muscle quality and increases its density, thus increasing 
the echogenicity of ultrasound images (17). Muscle thickness is used to estimate the degree 
of atrophy (24). Ultrasound thickness of the rectus femoris has been shown to be strongly 
correlated with muscle cross-sectional area (mCSA) (25). More recently, mCSA has been 
described as strongly correlated with muscle function. Accurate assessment of mCSA may be 
a tool for predicting strength, muscle power, overall health, and quality of life (21). It would 
appear that measurement of muscle echogenicity of the rectus femoris would be more valid 
for assessing muscle quality. According to Wilhelm et al. (2014) there is an inverse relationship 
between quadriceps echogenicity and functional capacity, suggesting that the accumulation 
of non-contractile elements within the muscle may be a mechanism related to non-neurological 
muscle loss (9). 
In the obese subject, ultrasound allows for improved analysis of muscle tissue by assessing 
the amount of muscle tissue versus non-muscle tissue (22).  
Loss of muscle strength combined with excessive body weight significantly impairs the ability 
to perform activities necessary for independence in daily living and proper body function (16). 
Choi et al (2015) showed that people with obesity, especially older individuals, are at increased 
risk for falls and functional decline (26). Thus, there is a decrease in exercise tolerance in 
subjects with obesity, the origin of which is multifactorial. The relative loss of muscle strength 
leads to greater fatigue during exercise and significantly limits the ability to perform the 
activities necessary to ensure independence in daily life (16). Peripheral muscle function 
requires the use of different assessment tools. Muscle capacity assessment tools, such as 
dynamometry or ultrasound, can be used to evaluate the different aspects of muscle function 
impacted by obesity (27). 
 

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2 Originality of the research
Excess body fat in obese patients appears to be responsible for muscle atrophy. This causal 
link is probably related to dysfunctions in adipose tissue, leading to a decrease in the 
expression of proteins responsible for muscle contraction (2). The recent literature highlights 
an alteration in quality of life, particularly in obese and elderly subjects, for which changes in 
muscle function would be partly responsible. In the general population of patients with obesity, 
especially adults and active people, this association has never been described and its 
mechanisms remain to be confirmed. 
Changes in muscle function, and its association with impaired quality of life, can be assessed 
by simple, rapid and non-invasive tools. This will allow the identification of obese subjects at 
risk of muscle risk of muscle atrophy, stratify the risk, and implement prophylactic intervention 
or early management.  
 
3 Research hypothesis 
We hypothesize that impaired peripheral muscle function is associated with impaired quality 
of life in subjects with obesity. 
 
 
 

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4 Objective
4.1 Main objective 
The main objective of this study is to evaluate the association between structural alteration of 
the quadriceps and quality of life in obese patients. 
 
4.2 Secondary objectives 
Secondary objectives are to assess: 
- 
The association between quadriceps thickness and quality of life; 
- 
The association between grip strength and quality of life; 
- 
The association between quadriceps strength and quality of life; 
- 
The association between quadriceps strength and ultrasound measurements of the 
quadriceps.  
 
5 Judging criteria 
5.1 Primary endpoint 
The primary end point was the association between femoral rectus muscle echogenicity and 
the SF-36 quality-of-life score (Appendix 1). 
 
5.2 Secondary endpoint 
Secondary endpoints will be: 
- 
The association between ultrasound thickness of the femoral rectus and the SF-36 quality 
of life score; 
- 
The association between grip strength measured by the hand-grip and the SF-36 quality 
of life score; 
- 
The association between quadriceps Voluntary Maximum Strength (VMS) on 
dynamometry and SF-36 quality of life score; 
- 
The association between quadriceps FMV at dynamometry and ultrasound measurements 
of the rectus femoris (thickness, echogenicity, and mCSA).  
 
 
 

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5.3 Inclusion criteria 
Patients with the following criteria will be included:  
- 
Hospitalized in day hospital (HDJ) Nutrition; 
- 
Obese patient (BMI > 30); 
- 
Patient at least 18 years of age at the time of inclusion; 
- 
Affiliation with a social security system or beneficiary of such a system ; 
- 
Oral, free, informed and express consent of the patient. 
 
5.4 Non-inclusion criteria 
Patients with the following criteria will not be included:  
- Patient refusal to participate in the study; 
- Known pregnancy; 
- Patient whose state of consciousness is not compatible with obtaining consent; 
- Person subject to a safeguard of justice measure ; 
- Patient under guardianship or curatorship. 
 
5.5 Recruitment procedures 
Patients will be recruited prospectively and consecutively in the HDJ Nutrition of the Forcilles 
Hospital. The physiotherapist or the investigating physician working in HDJ identifies the 
patients at their admission. 
 
6 Research design 
6.1 Type of study 
This is a prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling within the scope of article L.1121-1 of the Public Health Code. The research 
will be conducted in accordance with the protocol. 
 
 

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6.2 Research diagram  
 
 
 
 
 
 
 
 
 
 
 
6.3 Provisional research schedule 
The duration of recruitment will be 9 months with a follow-up of patients for one day, for a total 
estimated duration of the study of 9 months: 
- 
Submission to PPC: January 2022 
- 
Start of inclusions: March 2022 
- 
Duration of the inclusion period: 9 months 
- 
Duration of participation of each patient: 1 day 
- 
End of inclusions: January 2023 
- 
Total duration of the research: 9 months 
- 
Communication in congresses: Scientific days of the AFERO, other scientific congresses 
- 
Publication: international journal with review committee. 
 
6.4 Location of the study 
The study will take place in the HDJ Nutrition of the Forcilles Hospital. 
 
7 Description of the usual care in HDJ Nutrition  
7.1 Description of the usual course of care 
A total of 4 patients are admitted every Monday of the week and the last Thursday of the 
month. Patients are hospitalized for one day. The day begins with the reception of the patient 
by the nurse and continues with : 
Pre-inclusion 
visit
Admission in 
HDJ Nutrition 
Verification of 
inclusion and non-
inclusion criteria 
Inclusion visit 
Collection of 
inclusion data 
Visit of the 
physiotherapist 
Ultrasound of the quadriceps 
Handgrip 
Dynamometry 
SF-36 score 
End of 
research visit

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-
A dietary consultation;
- 
A psychological consultation; 
- 
Medical consultation; 
- 
A consultation by the physiotherapist;  
- 
A cardiological consultation. 
After the various consultations, a summary meeting is held with the doctor, nurse, 
physiotherapist, psychologist and dietician. This meeting allows us to define the therapeutic 
strategy that will be proposed to the patient. 
At the end of this meeting, the nurse receives the patient in consultation and informs him of 
the therapeutic proposals. Finally, the patient is received by the doctor in charge who gives 
him the hospitalization report. All the examinations and consultations are carried out within the 
usual framework of the HDJ Nutrition and are systematically prescribed by the doctor in 
charge. 
 
7.2 Standard evaluation procedures 
7.2.1 Hand Grip Force 
The maximum grip force of both hands will be measured with the portable hydraulic 
dynamometer JAMAR® (Sammons Preston Rolyan Nottinghamshire, UK) (Appendix 2). The 
dynamometer is adapted to each patient: adjustment of the hand allowing the flexion of the 
metacarpophalangeal joints. The grip force is obtained in kilograms (kg). 
The evaluation protocol consists of three maximum voluntary isometric contractions to be held 
for 5 seconds, with a minimum rest period of 60 seconds. The highest value will be used to 
determine the maximum grip strength. The patient is placed in a seated position, with the back 
against the back of the chair and the feet flat on the floor.  The arm position is standardized 
with the shoulder in adduction and neutral rotation, the elbow bent at 90°. The forearm is 
placed in a neutral position and rests on the support surface. The hand is aligned with the 
forearm. 
Specific verbal instructions and encouragement are given to the patient. 
 
7.2.2 Maximum Voluntary Force (MVF) of the quadriceps 
The FMV of the quadriceps will be measured using the MicroFet 2 dynamometer® (Appendix 
3). The patient is positioned in a seated position with the hip and knee flexed to 90 degrees. 
The dynamometer is positioned on the anterior surface of the ankle. The patient is asked to 
extend the knee to the maximum. Three maneuvers will be performed, with 30 seconds of rest 

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between each. The maximum value of the 3 measurements, which vary by less than 10%, will 
be retained. 
 
8 Evaluation procedures added by research 
8.1 Muscle ultrasound 
8.1.1 Operator training 
Ultrasound measurements are performed by one of the investigating physical therapists. The 
physiotherapist is authorized to perform ultrasound subject to training (Avis du Conseil 
National de l'Ordre des Masseurs-Kinésithérapeutes (2015)). The training of the operator 
corresponds to the following: 
- 
3 days of theoretical and practical training; 
- 
Over 100 ultrasounds supervised by an experienced practitioner; 
Similarly, all the physiotherapists performing the ultrasound scans are already involved in 
other research projects using lung, diaphragm and peripheral muscle ultrasound: 
https://clinicaltrials.gov/ct2/show/NCT02474797, 
https://clinicaltrials.gov/ct2/show/NCT02881814, 
https://clinicaltrials.gov/ct2/show/NCT04373811 
and 
https://clinicaltrials.gov/ct2/show/NCT04800783.  
 
8.1.2 Realization of the measurement 
A linear probe will be used to measure the thickness, echogenicity and cross-sectional area 
of the rectus femoris, according to the procedure described in Appendix 4. The patient is 
placed in the supine position (as strict as possible), with the lower limbs in extension and in a 
neutral rotation position. The probe is placed on the anterior aspect of the thigh, 2/3 of the 
distance between the anterior superior iliac spine and the upper edge of the patella, in line 
with the femur.  
In the transverse plane, the distance between the upper and lower fascia of the muscle body 
will be measured, directly on a frozen image. The thickness of the rectus femoris will be 
measured on the right side at rest, without patient participation. The average of 3 
measurements is used to improve the reliability of the measurement. 
The cross-sectional area (CSA) will also be measured. Still in the transverse plane, the cross-
sectional area of the rectus femoris is measured using the "caliper" function to trace the limits 
of the rectus femoris and measure its area. On the same frozen image, echogenicity will be 
measured using the Image J software® using the entire muscle surface. 

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The pennation angle of the femoral rectus will also be measured in a longitudinal plane.
 
8.2 Quality of Life Scale 
The SF-36 Quality of Life Questionnaire assesses health status independent of causative 
pathology, gender, age, and treatment. This scale can be administered as a self- or hetero-
questionnaire, and requires only 5 to 10 minutes. Its 36 items assess 8 dimensions (Appendix 
1): 
- 
Limitations due to physical condition; 
- 
Physical pain; 
- 
Perceived health; 
- 
Vitality; 
- 
Life and relationship with others; 
- 
Limitations due to physical condition; 
- 
Mental health. 
A sub-score for each component can be calculated, ranging from 0 to 100. The calculation is 
done according to an established algorithm. 
 
9 Conduct of the research 
9.1 Pre-inclusion visit 
9.1.1 Verification of inclusion and non-inclusion criteria 
At the time of admission of a patient in HDJ obesity, one of the investigators of the study 
verifies the presence of the inclusion criteria and the absence of the non-inclusion criteria in 
the computerized file of the patient. 
 
9.1.2 Patient information and consent 
When all the criteria allow the inclusion of the patient, the investigator informs the patient of 
the purpose of the study during the reception with the nurse. The investigator provides the 
patient with all the information described in the information note (Appendix 5) and, if 
necessary, obtains the patient's free, informed and express oral consent. This consent will be 
recorded in the patient's computerized medical record. 
 

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9.2 Inclusion visit 
The inclusion visit takes place during the consultation with the physical therapist. The following 
data will be collected:  
- 
Age, weight, height, BMI, gender (male/female);  
- 
Adipose tissue distribution profile (visceral or subcutaneous); 
- 
Reason for hospitalization: education, weight loss, assessment; 
- 
History: chronic respiratory disease (COPD, Asthma, pulmonary fibrosis), diabetes, 
hypertension, stroke, coronary artery disease, heart surgery, heart failure, cancer 
under treatment, smoking (active, weaned, none), alcohol, liver cirrhosis, 
immunosuppression (corticosteroids, HIV, chemotherapy, other), renal failure ; 
- 
Cardiovascular risk factors; 
- 
Biological markers (albumin, pre-albumin, CRP, glycated hemoglobin);  
- 
Autonomy Score (ADL Score, Appendix 6);  
- 
Depression and anxiety questionnaire (HAD, Appendix 7). 
 
9.3 Visit of the physiotherapist 
The physical therapist visit takes place after the inclusion visit. The following measurements 
will be performed: 
- 
Peripheral muscle ultrasound measurements: 
- 
Femoral rectus thickness; 
- 
Cross-sectional area of the femoral rectus; 
- 
Echogenicity; 
- 
Pennation angle. 
- 
Grip force; 
- 
Quadriceps FMV; 
- 
Quality of Life Questionnaire (SF-36). 
 
9.4 End of research visit 
This visit takes place during the end-of-day consultation. It is carried out by the doctor in 
charge of the unit, who gives the patient the hospitalization report and ensures the 
transcription of the information in the research observation book. 
 

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9.5 Summary table 
 
Pre-
inclusion 
Inclusion 
Visit of the 
physiotherapist 
End of research visit 
Information for the 
patient or family 
member 
 
 
 
 
Collection of basic data 
(age, sex, BMI, 
medical history, etc.)  
 
 
 
 
Collection of the 
reason for admission 
 
 
 
 
Collection of 
information relating to 
medical care  
 
 
 
 
GMF and handgrip 
 
 
 
 
Ultrasound 
examination 
 
 
 
 
SF - 36  
 
 
 
 
Finalization of the CRF 
 
 
 
 
 
 

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10 Statistical aspects
10.1 Calculation of the study size 
Two groups of patients will be identified within our obesity patient population: a group of 
patients with low quality of life and a group with high quality of life. The median SF-36 quality 
of life score will be used to differentiate these 2 groups. 
The echogenicity of the rectus femoris will be compared between these 2 groups, in order to 
evaluate the association between the muscular alteration of the rectus femoris by measuring 
echogenicity and the quality of life. 
To our knowledge, no publication has evaluated the echogenicity of the rectus femoris in a 
population of obese patients. In the literature, an echogenicity of the rectus femoris of 120.9 ± 
15.4 was found in a population of elderly patients (25). Given the presence of common 
pathophysiological mechanisms and similar sonographic characteristics (thickness and 
mCSA) in muscle damage between the elderly and obese patients, we hypothesize that the 
echogenicity of the rectus femoris in obese patients is similar to that in the elderly patient 
group with low quality of life. 
In the absence of clinically relevant echogenicity difference data, we pragmatically expect a 
difference of at least 10 points (based on the alteration in muscle echogenicity of the 
resuscitation patient in 7 days (28). 
-sided 
test is 42 patients per group, or 84 in total. 
 
10.2 General aspects 
Statistics will be primarily descriptive and will be based on means (+/- standard deviation) or 
medians [minimum-maximum] depending on the distribution of quantitative variables. 
Qualitative variables will be described in terms of numbers and percentages. Univariate 
comparisons will use the usual statistical tests after verification of the distribution of the 
variables (Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents Wilcoxon and 
Kruskal-Wallis tests). 
The risk of low quality of life in the presence of impaired muscle function will be described by 
Odd-Ratios. 
Tests will be performed at the 5% significance level. The 95% confidence intervals will be 
provided for each estimate.  
Calculations will be done using SPSS v21 IBM and R software (version 3.6.1, www.R-
project.org). 

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11 Expected results in terms of scientific and professional 
advances 
This study will evaluate the association between peripheral muscle function and quality of life 
impairment in obese patients hospitalized in HDJ Nutrition. 
The results of this study will confirm the association of muscle status on quality of life in obese 
patients, which is not yet clearly established in the scientific literature. If applicable, these 
results will make it possible to propose non-invasive and inexpensive predictive tools to screen 
for muscle damage in this patient population. This screening could make it possible to propose 
early management programs, such as exercise re-training or the introduction of adapted 
physical activity. 
 
12 Expected benefits and risks for patients 
12.1 Minimal risks and constraints added by the research 
The risks and constraints for the patient will only be the extra time spent by the patient on the 
ultrasound and the quality of life assessment questionnaire. Ultrasound is a non-invasive, non-
irradiating and totally painless tool. 
 
12.2 Expected benefits for the patient 
The use of non-invasive tests of muscle function could allow early identification of obese 
subjects whose impairment of muscle function could be associated with a poorer quality of 
life. This could allow us to propose an adapted therapeutic strategy, such as the 
implementation of an exercise training program, adapted physical activity or therapeutic 
education. 
 
13 Feasibility 
The patients are included in the HDJ Nutrition of the Forcilles Hospital. The whole of care, 
treatments, examinations and samples being carried out within the framework of their 
therapeutic and diagnostic management, the conditions relating to the human, material and 
technical means are ensured. However, if an incident were to occur, the patients would benefit 
from all the human and technical means of the hospital to guarantee their safety, in 

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accordance with the rules of hygiene and safety in force and in the respect of the integrity of 
the patient. 
In addition, the medical and paramedical teams involved in this study have experience in 
clinical research, as they have already participated in other clinical trials. 
Taking into account the inclusion and non-inclusion criteria, possible refusals of patients to 
participate in the research, potential exclusions and the recruitment experience, we estimate 
a minimum recruitment capacity of 50% of patients admitted to HDJ Obesity, i.e. 10 patients 
in 9 months. 
 
14 Ethical and regulatory aspects 
The Forcilles-Fondation Cognacq-Jay hospital promoter and the person(s) directing and 
supervising the research undertake that this research will be carried out in compliance with 
law n°2004-806 of August 9, 2004 relating to public health policy and the regulatory provisions 
in force (articles L.1121-1, L.1121-2 and L.1121-3 of the Public Health Code. The data 
recorded during this research will be subject to computerized processing in compliance with 
Law No. 78-17 of January 6, 1978 on information technology, files and freedoms, as amended 
by Law No. 2018-493 of June 20, 2018 (Decree No. 2018-687 of August 1, 2018) and Order 
No. 2018-1125 of December 12, 2018. 
The research will be conducted in accordance with this protocol. 
 
14.1 Role of the promoter 
The research commission of the Forcilles-Fondation Cognacq-Jay hospital, promoter of this 
research, submits the file to the opinion of the concerned Committee for the Protection of 
Persons (CPP) (CPP Sud-Méditerranée I) whose opinion will be notified in the information 
note intended for the persons concerned. 
The natural or legal person who initiates this research, ensures its management and verifies 
that its financing is provided for, is called the sponsor. 
 
14.2 Submission to PPC 
This research will be submitted to a Committee for the Protection of Persons, which will be 
drawn by lot in the framework of the "Jardé Law" (Article L.1121-4 of the Public Health Code, 
Decree No. 2016-1537 of November 16, 2016, which went into effect on November 18, 2016). 

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The opinion of the above-mentioned committee is notified in the information note intended for 
the persons concerned. A copy of this opinion and a summary of the research will be sent to 
the ANSM. 
 
14.3 Data protection 
This research is subject to the law n°78-17 of January 6, 1978 relating to data processing, 
files and freedoms modified by the law n° 2018-493 of June 20, 2018 (decree n° 2018-687 of 
August 1, 2018). Information on the rights of persons participating in this research (right of 
access and rectification, right to object to the transmission of data covered by professional 
secrecy likely to be used in the context of this research) is included in the information note 
intended for the patient. 
A reference methodology specific to the processing of personal data operated within the 
framework of biomedical research defined by Law 2004-806 of August 9, 2004 as falling within 
the scope of Articles L.1121-1 et seq. of the Public Health Code was updated by the CNIL in 
May 2018 (Deliberation No. 2018-153 of May 3, 2018) following the publication of European 
Regulation No. 2016/679 (General Data Protection Regulation). This methodology allows a 
simplified declaration procedure when the nature of the data collected in the research is 
compatible with the list provided by the CNIL in its reference document. This study is part of 
the MR001 reference methodology to which the Forcilles-Fondation Cognacq-Jay hospital has 
committed to comply. 
 
14.4 Insurance 
The Sponsor takes out insurance covering its own civil liability and that of all participants 
involved in the research, regardless of the nature of the relationship between the participants 
and the Sponsor (article L.1121-10 of the Public Health Code). The sponsor also ensures the 
compensation of the harmful consequences of the research for the person who takes part in 
it and for his or her beneficiaries, unless it can prove that the damage is not attributable to its 
fault or to that of any other party involved, without being able to invoke the act of a third party 
or the voluntary withdrawal of the person who had initially agreed to take part in the research. 
When the sponsor is not liable, the victims may be compensated under the conditions set out 
in article L.1142-3. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract 
n°163607 guaranteeing its civil liability as well as that of any intervening party with the 
company SHAM for the entire duration of the research, in accordance with article L.1121-10 
of the Public Health Code. 

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14.5 Substantial change to the protocol 
The investigator or coordinator informs the Forcilles-Fondation Cogacq-Jay Hospital Research 
Committee of any proposed modification of the protocol. Any substantial modification will be 
submitted by the sponsor of this research to the CPP for its opinion. 
 
14.6 Disclosure and Express Consent 
In accordance with Article L.1122-1 of the Public Health Code, the information given to 
persons who are to undergo research is the subject of a written document submitted in 
advance to the personal protection committee. The ethical opinion of the CPP Sud-
Méditerranée I has been requested. 
The investigator of the center proposes to the patient, or to a relative if the patient is unable 
to participate, to take part in the study. The investigator informs the patient orally about the 
study and gives him/her the information note. If the patient gives free, informed and express 
oral consent to participate in the protocol, the information given orally and in writing, as well 
as the collection of oral consent, will be recorded in the patient's medical record. 
In the case where a relative of the patient has given consent, as soon as possible, the patient 
will be informed of this research and asked for oral consent for the possible continuation of 
the research. 
Patients are free to participate or withdraw from the study at any time in accordance with 
Article 21 of the GDPR. Data collected until the patient withdraws consent will be used unless 
specifically requested by the patient. The withdrawal of consent by the patient and the 
agreement to use or not the previously collected data will be traced in the patient's medical 
record. 
When the research is completed, the individual may be informed of the overall results of the 
research in the manner specified in the disclosure document. 
 
14.7 Anticipated deadline for publication of results in an 
international journal 
The deadline for the publication of the results is 15 months. 
 

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14.8 Data management 
For each subject, an identification code (corresponding to the center number-inclusion 
number-Initial Surname-Initial First Name) will be assigned. The data collected will be 
confidential and coded (only the identification code will appear). The concordance table linking 
the assigned identification code and the participant's name will be kept by the principal 
investigator at each participating center in a file with limited computer access rights. The data 
will be entered in an Excel® file. Data processing and statistical analysis will be carried out at 
the Forcilles-Fondation Cognacq-Jay hospital. 
The promoter is the owner of the data and no use or transmission to a third party can be made 
without its prior agreement. 
The specific documents of a type 2 interventional research ("Loi Jardé", decree n° 2016-1537 
of November 16, 2016, which went into effect on November 18, 2016) with minimal risks and 
constraints will be archived by all parties for 15 years after the end of the research. 
This indexed archive includes: 
- 
successive versions of the protocol (identified by version number and date); 
- 
correspondence; 
- 
Inclusion list or register; 
- 
the data collection document ; 
- 
research-specific appendices; 
- 
the final report of the research. 
The database used for the statistical analysis must also be archived by the person responsible 
for the analysis (paper or computer). 
 
14.9 Human and financial resources 
The Forcilles-Fondation Cognacq-Jay hospital is equipped with human, material and technical 
resources to carry out this research project. 
 
14.10 Data properties 
The Forcilles-Fondation Cognacq-Jay Hospital is the owner of the data and no use or 
transmission to a third party may be made without its prior agreement. 
 
 

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15 Bibliographic References
1.  
Toselli S, Campa F, Spiga F, Grigoletto A, Simonelli I, Gualdi-Russo E. The association between 
body composition and quality of life among elderly Italians. Endocrine. May 2020;68(2):
.  
2.  
Fat and muscle do not mix Inserm, Science for health [Internet]. Inserm. [cited 5 Sep 2021]. 
Available from: https://www.inserm.fr/actualite/gras-et-muscle-ne-font-pas-bon-menage/ 
3.  
Tamura LS, Cazzo E, Chaim EA, Piedade SR. Influence of morbid obesity on physical capacity, 
knee-related symptoms and overall quality of life: A cross-sectional study. Rev Assoc Médica 
Bras. Feb 2017;63(2):
.  
4.  
Obesity [Internet]. Inserm - Science for health. 2020 [cited 13 Jul 2020]. Available from: 
https://www.inserm.fr/information-en-sante/dossiers-information/obesite 
5.  
Causes of obesity presented by the bariatric surgical team of the CHRU Lille [Internet]. [cited June 
5, 2021]. Available from: https://www.chirurgieobesitelille.com/obesite-causes.html 
6.  
Orange ST, Marshall P, Madden LA, Vince RV. Can sit-to-stand muscle power explain the ability 
to perform functional tasks in adults with severe obesity? J Sports Sci. June 2019;37(11):
.  
7.  
Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and 
obesity using standard body mass index categories: a systematic review and meta-analysis. 
JAMA. 2 Jan 2013;309(1):
.  
8.  
Shultz SP, Byrne NM, Hills AP. Musculoskeletal Function and Obesity: Implications for Physical 
Activity. Curr Obes Rep. Sep 2014;3(3):
.  
9.  
Wilhelm EN, Rech A, Minozzo F, Radaelli R, Botton CE, Pinto RS. Relationship between 
quadriceps femoris echo intensity, muscle power, and functional capacity of older men. Age 
[Internet]. 
June 
2014 
[cited 
March 
29, 
2021];36(3). 
Available 
from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082605/ 
10.  Da Silva MP, Jorge Z, Domingues A, Nobre EL, Chambel P, De Castro JJ. [Obesity and quality 
of life]. Acta Med Port. June 2006;19(3):
.  
11.  WHO_HPR_HEP_98.1_eng.pdf 
[Internet]. 
[cited 
5 
Sep 
2021]. 
Available 
from: 
https://apps.who.int/iris/bitstream/handle/10665/67245/WHO_HPR_HEP_98.1_fre.pdf 
12.  Kim S-R, Kim H-N, Song S-W. Associations Between Mental Health, Quality of Life, and 
Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. Sept 2020;18(7):
.  
13.  Briggs MS, Bout-Tabaku S, Buell J, White S, Rosenstein PF, Schmitt LC. A preliminary evaluation 
of the associations among functional performance tasks and quality of life in obese and healthy 
weight youth. J Sports Sci. Jan 2019;37(1):
.  
14.  Tomlinson DJ, Erskine RM, Winwood K, Morse CI, Onambélé GL. The impact of obesity on 
skeletal muscle architecture in untrained young vs. old women. J Anat. dec 2014;225(6):
.  
15.  Maffiuletti NA, Jubeau M, Munzinger U, Bizzini M, Agosti F, De Col A, et al. Differences in 
quadriceps muscle strength and fatigue between lean and obese subjects. Eur J Appl Physiol. 
Sept 2007;101(1):
.  
16.  Rastelli F, Capodaglio P, Orgiu S, Santovito C, Caramenti M, Cadioli M, et al. Effects of muscle 
composition and architecture on specific strength in obese older women. Exp Physiol. 
2015;100(10):
.  

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17. 
Ismail C, Zabal J, Hernandez HJ, Woletz P, Manning H, Teixeira C, et al. Diagnostic ultrasound 
estimates of muscle mass and muscle quality discriminate between women with and without 
sarcopenia. Front Physiol. 2015;6:302.  
18.  Giuliani HK, Shea NW, Gerstner GR, Mota JA, Blackburn JT, Ryan ED. The Influence of Age and 
Obesity-Altered Muscle Tissue Composition on Muscular Dimensional Changes: Impact on 
Strength and Function. J Gerontol Ser A. 13 Nov 2020;75(12):
.  
19.  Maffiuletti NA, Ratel S, Sartorio A, Martin V. The Impact of Obesity on In Vivo Human Skeletal 
Muscle Function. Curr Obes Rep. Sep 1, 2013;2(3):
.  
20.  Pellegrinelli V, Rouault C, Rodriguez-Cuenca S, Albert V, Edom-Vovard F, Vidal-Puig A, et al. 
Human Adipocytes Induce Inflammation and Atrophy in Muscle Cells During Obesity. Diabetes. 
sept 2015;64(9):
.  
21.  Melvin MN, Smith-Ryan AE, Wingfield HL, Fultz SN, Roelofs EJ. Evaluation of muscle quality 
reliability and racial differences in body composition of overweight individuals. Ultrasound Med 
Biol. Sep 2014;40(9):
.  
22.  Blue MNM, Smith-Ryan AE, Trexler ET, Hirsch KR. The effects of high intensity interval training 
on muscle size and quality in overweight and obese adults. J Sci Med Sport. Feb 2018;21(2):
.  
23.  Saranteas T. Limitations in ultrasound imaging techniques in anesthesia: obesity and muscle 
atrophy? Anesth Analg. Sept 2009;109(3):
.  
24.  Pillen S, van Alfen N. Skeletal muscle ultrasound. Neurol Res. Dec 2011;33(10):
.  
25.  Strasser EM, Draskovits T, Praschak M, Quittan M, Graf A. Association between ultrasound 
measurements of muscle thickness, pennation angle, echogenicity and skeletal muscle strength 
in the elderly. Age. dec 2013;35(6):
.  
26.  Choi SJ, Files DC, Zhang T, Wang Z-M, Messi ML, Gregory H, et al. Intramyocellular Lipid and 
Impaired Myofiber Contraction in Normal Weight and Obese Older Adults. J Gerontol A Biol Sci 
Med Sci. Apr 2016;71(4):
.  
27.  Jurio-Iriarte B, Gorostegi-Anduaga I, Aispuru GR, Pérez-Asenjo J, Brubaker PH, Maldonado-
Martín S. Association between Modified Shuttle Walk Test and cardiorespiratory fitness in 
overweight/obese adults with primary hypertension: EXERDIET-HTA study. J Am Soc Hypertens. 
Apr 2017;11(4):
.  
28.  Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, et al. Quantitative 
neuromuscular ultrasound in the intensive care unit. Muscle Nerve. feb 2013;47(2):
.  
 
 
 

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16 APPENDICES
16.1 Appendix 1: SF-36 Quality of Life Score 
 
 

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16.2 Appendix 2: Handgrip Usage Protocol 
The patient will be in a seated position, on a chair with a backrest, feet on the ground. 
The shoulder will be in adduction (elbow to body), without extension or flexion, and in neutral 
rotation. The elbow will be placed at 90° of flexion and in neutral prono-supination. The wrist 
should also be in neutral position. The practitioner will slightly hold the elbow and the base of 
the JAMAR dynamometer® in order to avoid positioning changes. The grip force measurement 
will include 3 measurements on each limb, alternating with a rest (1 minute: time to note the 
score of the measurement and to quietly settle the person in the position for the next 
measurement). 
 
The dominant hand will be chosen by the participant by answering the following question: "Are 
you right or left handed? 
 
The instructions are: "Lean back against the backrest. Take the handle in your hand, keep 
your elbow close to your body and your forearm straight in front of you" and progressively 
tighten the handle over 2 to 3 seconds to reach a maximum tightening that you must also 
maintain for 2 to 3 seconds, without moving the other joints (wrist, elbow and shoulder). 
Encouragement will be given to the person during the clamping seconds to motivate the 
patient as much as possible: "Go ahead and clamp, clamp... hard, HARD! TIGHT! ...and you 
release". It will be noted if a pain appears and limits the grip.  
 
 
 
 
 
 
 
 
 
 
 
 

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16.3 Appendix 3: Maximum Voluntary Force (MVF) of the quadriceps 
 
 
Bachasson et al. Ambulatory measurement of isometric maximum voluntary quadriceps 
force in COPD patients, Rev Mal Respir, 2014 
 
Predicted Quadriceps force (Nm)
Q Right 
FMV(Nm)= 66.37 - (0.87 x age) + (46.09 x Sex [0 if female, 1 if male]) + (1.21 
x weight (Kg)). 
Q Left 
FMV(Nm)= 78 - (0.87 x age) + (49.70 x Sex [0 if female, 1 if male]) + (0.96 x 
weight (Kg)). 
 
Hogrel. JY et al. Development of a French isometric strength normative database for adults using quantitative muscle testing. Arch Phys Med 
Rehabil, 2007 
 
 

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16.4 Appendix 4: Muscle ultrasound procedure 
A linear probe will be used for the measurements. A set of predefined settings of the gain and 
depth parameters will be used for all measurements. 
 
Patient positioning 
The patient is installed in dorsal decubitus (as strict as possible), with the lower limbs in 
extension and neutral position of rotation. 
 
Placement of the probe 
The probe is placed in contact with the skin via an ultrasound gel. The pressure exerted with 
the probe is perpendicular to the plane of the bed, in line with the femur and must be as low 
as possible to obtain a representative image of the muscle. Excessive pressure will cause 
deformation of the subcutaneous tissues and therefore of the muscle. There are two ways of 
orienting the probe: in the transverse or sagittal plane. 
 
Measurements on the quadriceps 
 
Figure 1 
 
The probe is placed on the anterior aspect of the thigh, 2/3 of the way from the anterior superior 
iliac spine to the upper edge of the patella, plumb with the femur (Figure 1) (39). The muscle 
chiefs studied were the rectus femoris and the vastus intermedius. 
 

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Figure 2 
 
Muscle thickness 
In the transverse plane, measurement of the distance between the upper and lower fascias of 
the muscle body (Figure 2). It is measured directly on a frozen image. The thickness of the 
rectus femoris (DF) and the vastus intermedius (VI) will be measured on the right. The average 
of 3 measurements will be taken. 
 
 
Figure 3 
 
Cross-Sectional Area (CSA): 
DF 
VI 

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Still in the transverse plane, measure the cross-sectional area of the rectus femoris using the 
caliper to delineate the boundaries of the rectus femoris (Figure 3). 
 
Pennation angle 
Place the probe along the axis of the muscle. The angulation of the muscle fibers in relation 
to the underlying fascia becomes visible (pennation of the fibers (Figure 4). The angle between 
a muscle fiber and the underlying fascia will be measured only on the rectus femoris: 
 
 
Figure 4 
 
Echogenicity 
Save the image used to measure the thickness and cross-sectional area. In the Image J 
software, delimit a 1 cm area2 and analyze the variations of the gray levels. The software 
provides a histogram with a global value of the grey level going from 0 to 255 - 0 corresponding 
to black and 255 to white (28). 
 
 

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Patient information note  
OVALIA  
""Study of the association between peripheral muscle function and quality of 
life in subjects with obesity"" 
 
RCB ID : 2021-A03248-33 
 
PRINCIPAL INVESTIGATOR 
Dr. Sophie Vidal-Jessel, internist, specialized in nutrition 
Forcilles Hospital 
Department of Diabetology -Endocrinology 
Route de Servon 77150 Férolles-Attilly 
Email : svidaljessel@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Office 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Phone : 01.60.64.61.31 
Fax : 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Madam, Sir, 
Dr. ..............................................., investigator of the study, practicing in the Diabetes-Obesity 
Department of the Forcilles-Fondation Cognacq-Jay Hospital, invites you to participate in this 
research. 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have, and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are hospitalized in a nutrition day hospital as part of the assessment of your pathology. 
Your state of health requires the evaluation of your muscular condition in order to adapt your 
medical and paramedical care. 
 
 

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What is the purpose of this research?
The objective of this research is to evaluate the association between the muscle function of 
the quadriceps (thigh muscle) and your quality of life. The results of this study will allow us to 
confirm the association of muscle status on quality of life, which is not yet clearly established 
in the scientific literature. If applicable, these results will make it possible to propose non-
invasive and inexpensive predictive tools to screen for muscle damage. This screening could 
make it possible to propose early management programs, such as exercise re-training or the 
introduction of adapted physical activity. 
 
How does this research work? 
As part of your hospitalization in the department, we propose to study the state of your muscle 
function by performing an ultrasound of your thigh muscle and asking you questions via a 
standardized quality of life evaluation questionnaire. 
The ultrasound examination is painless, non-invasive and risk-free. It is performed by the 
physiotherapist, using the ultrasound machine, an ultrasound probe and gelled water. It lasts 
about 10 minutes. 
The quality assessment questionnaire consists of 11 questions and takes about 10 minutes to 
complete. 
This research visit will take place only once, in one of the consultation rooms of the Nutrition 
Day Hospital at Forcilles Hospital, for a total of 20 minutes.  
 
Your constraints in this research? 
The constraints of this research consist in passing 1 ultrasound and 1 questionnaire, over a 
maximum total duration of 20mn. 
 
Possible adverse effects 
Since your participation in this protocol does not involve any treatment other than that which 
is currently recommended or any other modification of the conventional management adapted 
to your health condition, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
The ultrasound will be performed transcutaneously, i.e. by placing the probe on your skin. 
The examination is therefore non-invasive and completely painless. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
 

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What are the expected benefits of this research? 
The use of non-invasive tests of muscle function could allow early identification of obese 
subjects whose impairment of muscle function could be associated with a poorer quality of 
life. This could allow us to propose an adapted therapeutic strategy, such as the 
implementation of an exercise training program, adapted physical activity or therapeutic 
education. 
 
What are the requirements to participate in this study? 
In order to participate in this research, you must be affiliated with or benefit from a social 
security plan. However, your participation in this research will not generate any additional 
costs for you compared to those incurred in the usual care. 
 
 
What data is collected for research? 
The medical data collected during this study will be processed in a computerized, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, nutritional status, biological check-ups, and the results of 
medical check-ups. No information bearing your name will be provided to anyone except the 
physician in charge of the study and authorized personnel. All data collected will be 
confidential and coded and analyzed in the clinical research office of the Forcilles-Fondation 
Cognacq-Jay Hospital, the sponsor of the research. The identification list (correspondence 
between your study code and your identity) will be kept strictly confidential. 
In accordance with current regulations, the data will be kept until the final research report is 
produced and then archived for 15 years. 
The person responsible for processing the data is the promoter, Hôpital Forcilles-Fondation 
Cognacq-Jay, route de Servon 77150 Férolles-Attilly. 
 
 
 
Legal basis for data processing 
The processing of data is based on the legitimate interests of the controller, Article 6 paragraph 
1 point f, read in conjunction with the necessity of processing for scientific research purposes, 
Article 9 paragraph 2 point j, of the European Regulation No. 2016/679 (General Data 
Protection Regulation, GDPR). 

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What are your rights? 
Your participation in this research is completely free and voluntary. You have the right not 
to participate in this research. 
You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the Public Health Code, the entire research file 
has been submitted to the Comité de Protection des Personnes Sud-Méditerranée I which 
issued a favorable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop your participation in the research at any time without justification. This will not 
affect the quality of the care and treatment provided to you or your relationship with your 
doctor. The data collected until you withdraw your consent will be used unless you expressly 
request it. Indeed, in accordance with Article 17 of the RGPD, you have the right to request 
the deletion of your data already collected. The withdrawal of your consent and the agreement 
to use or not your previously collected data will be traced in your medical file. 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 
April 2016 (General Data Protection Regulation), you have a right of access, rectification, 
deletion of these or a limitation of processing. You can find out more about your rights by 
visiting 
the 
CNIL 
website 
page 
https://www.cnil.fr/fr/reglement-europeen-protection-
donnees/chapitre3. In accordance with the provisions of Article 21 of the RGPD, you also have 
the right to object to the transmission of data likely to be used in this research and to be 
processed. Your request must be addressed to the Data Protection Officer of the Cognacq-
Jay Foundation, either by e-mail to dpo@cognacq-jay.fr or by post to the following address: 
Hôpital Forcilles-Fondation Cognacq-Jay, Délégué à la Protection des Données, route de 
Servon 77150 Férolles-Attilly. You also have the right to lodge a complaint with the 
Commission Nationale de l'Informatique et des Libertés - CNIL (French personal data control 
authority, website: www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 

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If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to think about your decision and you decide to 
participate in this research, the research information and your oral consent will be notified and 
dated in your medical record. 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
additional information you may require before and during the research. 
 
Dr. ________________________, the study investigator, certifies that he has obtained the 
patient's oral consent and recorded it in his medical record. 
 
 
 Date of consent collection: ____ / _____ / _______  
 
 
 
Investigator's signature: 
 

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16.5 Appendix 6: Katz ADL (Activities in Daily Living) Scale 
 
 
 
 

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16.6 Appendix 7: Hospital Anxiety and Depression Scale  
 
1) Anxiety  
  
I feel tense or irritated.  
0 
Never.  
1 
From time to time.  
2 
Often.  
3 
Most of the time.  
  
I have a feeling of fear as if something horrible is going to happen to me.  
0 
Not at all.  
1 
A little, but that doesn't worry me.  
2 
Yes, but it's not too bad.  
3 
Yes, very clearly.  
  
I'm worried.  
0 
Very occasionally.  
1 
Occasionally.  
2 
Quite often.  
3 
Very often.  
  
I can sit quietly doing nothing and feel relaxed.  
0 
Yes, no matter what.  
1 
Yes, in general.  
2 
Rarely.  
3 
Never.  
  
I have feelings of fear and a knot in my stomach.  
0 
Never.  
1 
Sometimes.  
2 
Quite often.  
3 
Very often.  
  
I'm restless and can't stand still.  
0 
Not at all.  
1 
Not so much.  
2 
A little.  
3 
Yes, that's exactly the case.  
  
I have sudden feelings of panic.  

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0
Never. 
1 
Not very often.  
2 
Quite often.  
3 
Very often.  
  
 
2) Depression  
  
I enjoy the same things I used to.  
0 
Yes, just as much.  
1 
Not so much.  
2 
Just a little.  
3 
Almost no more.  
  
I laugh easily and see the good side of things.  
0 
As much as in the past.  
1 
Not as much as before.  
2 
Really less than before.  
3 
Not at all.  
  
I am in a good mood.  
0 
Most of the time.  
1 
Quite often.  
2 
Rarely.  
3 
Never.  
  
I feel like I'm running in slow motion.  
0 
Never.  
1 
Sometimes.  
2 
Very often.  
3 
Almost always.  
  
I'm no longer interested in my appearance.  
0 
I pay as much attention to it as I did in the past.  
1 
I may not pay as much attention to it anymore.  
2 
I don't pay as much attention to it as I should.  
3 
Not at all.  
  
I look forward to doing some things.  
0 
As much as before.  
1 
A little less than before.  
2 
Much less than before.  
3 
Almost never.  

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I can enjoy a good book or a good radio or television program.  
0 
Often.  
1 
Sometimes.  
2 
Rarely.  
3 
Very rarely.  
  
  
  
Results:  
  
This scale explores anxiety and depressive symptoms.  
Add up the anxiety and depression sides: 21 points maximum for each.  
Between 8 and 10: questionable anxiety or depression.  
Above 10: definite state of anxiety or depression.  
   
References:   
Depression and anxiety-depressive syndromes, J.D.Guelfi et al, Ardix Médical.  
 
 
 

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17 List of investigators
 
LIST OF INVESTIGATORS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Sophie VIDAL-JESSEL 
Principal 
Investigator 
Physician  
svidaljessel@cognacq-jay.fr 
01.60.64.61.62 
Andreia GOMES LOPES  
Co-investigator 
Physiotherapist 
alopes@cognacq-jay.fr 
Aymeric LE NEINDRE 
Co-investigator 
Clinical 
Research 
Coordinator 
aleneindre@cognacq-jay.fr 
0160646093 
Carlos DIAZ LOPEZ  
Co-investigator 
Physiotherapist 
cdiazlopez@cognacq-jay.fr  
0160646130