ObesityOVALIANCT05467020
Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects
An observational study of Obesity, run by Hopital Forcilles at 1 site in France.
Trial summary
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2022to 2 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients assessment nutrition will be recruited prospectively and consecutively
Who may be able to join
- Patients with the following criteria will be included:
- Outpatients assessment Nutrition ;
- Obese patients (BMI > 30);
- Patient at least 18 years old at the time of inclusion;
- Affiliation with a social security scheme or beneficiary of such a scheme ;
- Oral, free, informed and express consent of the patient.
Who cannot join
- Patient's refusal to participate in the study ;
- Known pregnancy ;
- Patient whose state of consciousness is not compatible with obtaining consent ;
- Person subject to a legal protection measure ;
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects.
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. 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. The 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 be used to identify obese subjects at risk of they could be used to identify obese subjects at risk of muscle atrophy, to stratify the risk, and to propose prophylactic intervention or early management.
The main objective of this study is to evaluate the association between structural alteration of the quadriceps and quality of life in obese patients.
Read more
The secondary objectives are to evaluate :
- 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.
This is a prospective, monocenter, observationnal and cohort study.
All outpatients for nutrition assessment will be included.
Read the detailed description
- Rationale 1.1 Obesity, a global public health Obesity is a disease of multifactorial origin, linked to nutritional alterations, genetic, psychological, socio-economic factors and more sedentary behaviour (4) (5). The prevalence of obesity continues to increase in all age groups and in all socio-economic groups. 1.2 Functional consequences of obesity. Patients with obesity with or without metabolic disorders have impaired health, including mental problems and reduced quality of life (12). In younger obese subjects the investigators 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). 1.2.1 Peripheral muscle damage A decrease in the specific force of the muscle, a decrease in force in relation to the sectional area, is observed in subjects with obesity. There is therefore probably a structural alteration of the muscle in the obese patient, which has not yet been described in the literature (17). 1.3 Peripheral muscle ultrasound Muscle ultrasound measurements have become increasingly used as a non-invasive method of determining 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.
- Research hypothesis The investigators hypothesise that impaired peripheral muscle function is associated with impaired quality of life in obese subjects.
3 Objective 3.1 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.
3.2 Secondary objectives
The secondary objectives are to evaluate :
- 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.
- Type of study This is a prospective, monocenter, obversational cohort study. The research will be conducted in accordance with the protocol.
- The duration of recruitment will be 9 months.
- Standard assessment procedures: Hand Grip Force, Maximum Voluntary Force of the quadriceps.
- Assessment procedures added by the research: Muscle ultrasound and Quality of Life Scale.
- Statistical 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 the Odd-Ratios.
Tests will be performed at the 5% significance level. The 95% confidence intervals will be provided for each estimate.
- 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 help confirm the association of muscle status on quality of life in obese patients, which is not yet clearly established in the scientific literature. If appropriate, 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 programmes, such as exercise re-training or the introduction of adapted physical activity.
- 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 programme, adapted physical activity or therapeutic education.
- Conditions
- Obesity
- Keywords
- obesity, muscle assessment, ultrasonography
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between structural alteration of the quadriceps and quality of life in obese patients
The main outcome is the association between rectus femoris muscle echogenicity in the gray scale and the 36-Item Short Form Survey (SF-36) score
Measured: Through study completion, an average of 9 months
Secondary outcomes (4)
The association between quadriceps thickness and quality of life
The main outcome is the association between ultrasound thickness of the rectus femoris and the 36-Item Short Form Survey (SF-36) score
Measured: Through study completion, an average of 9 months
Association between grip strength and quality of life
The main outcome is the association between grip strength measured by the hand-grip and the 36-Item Short Form Survey (SF-36) score
Measured: Through study completion, an average of 9 months
Association between quadriceps strength and quality of life
The main outcome is the association between quadriceps maximal voluntary force on dynamometry and the 36-Item Short Form Survey (SF-36) score
Measured: Through study completion, an average of 9 months
Association between quadriceps strength and ultrasound measurements of the quadriceps
The main outcome is the association between quadriceps FMV with dynamometry and ultrasound measurements of the rectus femoris (thickness, echogenicity and mCSA)
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start22 Apr 2022
- Primary completion22 Jul 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Forcilles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie VIDAL-JESSEL, MD, Study director, Hopital ForcillesAndreia GOMES LOPES, MSc, Principal investigator, Hopital ForcillesAymeric Le Neindre, PhD, Study chair, Hopital Forcilles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467020
- Sponsor's protocol ID
- 2021-A03248-33
- Acronym
- OVALIA
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocole, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.
Publications
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. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.
PubMed 31893349Tamura 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 Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.
PubMed 28355375Kim SR, Kim HN, Song SW. Associations Between Mental Health, Quality of Life, and Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. 2020 Sep;18(7):347-352. doi: 10.1089/met.2020.0028. Epub 2020 May 19.
PubMed 32429802
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects.
- ClinicalTrials.gov ID
- NCT05467020
- Acronym / sponsor ID
- OVALIA / 2021-A03248-33
- Conditions
- Obesity
- Keywords
- obesity, muscle assessment, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hopital ForcillesUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. 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. The 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 be used to identify obese subjects at risk of they could be used to identify obese subjects at risk of muscle atrophy, to stratify the risk, and to propose prophylactic intervention or early management.
The main objective of this study is to evaluate the association between structural alteration of the quadriceps and quality of life in obese patients.
The secondary objectives are to evaluate :
- 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.
This is a prospective, monocenter, observationnal and cohort study.
All outpatients for nutrition assessment will be included.
Detailed description
- Rationale 1.1 Obesity, a global public health Obesity is a disease of multifactorial origin, linked to nutritional alterations, genetic, psychological, socio-economic factors and more sedentary behaviour (4) (5). The prevalence of obesity continues to increase in all age groups and in all socio-economic groups. 1.2 Functional consequences of obesity. Patients with obesity with or without metabolic disorders have impaired health, including mental problems and reduced quality of life (12). In younger obese subjects the investigators 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). 1.2.1 Peripheral muscle damage A decrease in the specific force of the muscle, a decrease in force in relation to the sectional area, is observed in subjects with obesity. There is therefore probably a structural alteration of the muscle in the obese patient, which has not yet been described in the literature (17). 1.3 Peripheral muscle ultrasound Muscle ultrasound measurements have become increasingly used as a non-invasive method of determining 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.
- Research hypothesis The investigators hypothesise that impaired peripheral muscle function is associated with impaired quality of life in obese subjects.
3 Objective 3.1 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.
3.2 Secondary objectives
The secondary objectives are to evaluate :
- 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.
- Type of study This is a prospective, monocenter, obversational cohort study. The research will be conducted in accordance with the protocol.
- The duration of recruitment will be 9 months.
- Standard assessment procedures: Hand Grip Force, Maximum Voluntary Force of the quadriceps.
- Assessment procedures added by the research: Muscle ultrasound and Quality of Life Scale.
- Statistical 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 the Odd-Ratios.
Tests will be performed at the 5% significance level. The 95% confidence intervals will be provided for each estimate.
- 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 help confirm the association of muscle status on quality of life in obese patients, which is not yet clearly established in the scientific literature. If appropriate, 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 programmes, such as exercise re-training or the introduction of adapted physical activity.
- 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 programme, adapted physical activity or therapeutic education.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients assessment nutrition will be recruited prospectively and consecutively
Key inclusion criteria (6 listed)
- Outpatients assessment Nutrition ;
- Obese patients (BMI > 30);
- Patient at least 18 years old at the time of inclusion;
- Affiliation with a social security scheme or beneficiary of such a scheme ;
- Oral, free, informed and express consent of the patient.
Key exclusion criteria (5 listed)
- Patient's refusal to participate in the study ;
- Known pregnancy ;
- Patient whose state of consciousness is not compatible with obtaining consent ;
- Person subject to a legal protection measure ;
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between structural alteration of the quadriceps and quality of life in obese patients
Time frame: Through study completion, an average of 9 months
The main outcome is the association between rectus femoris muscle echogenicity in the gray scale and the 36-Item Short Form Survey (SF-36) score
4 secondary outcomes
The association between quadriceps thickness and quality of life
Time frame: Through study completion, an average of 9 months
Association between grip strength and quality of life
Time frame: Through study completion, an average of 9 months
Association between quadriceps strength and quality of life
Time frame: Through study completion, an average of 9 months
Association between quadriceps strength and ultrasound measurements of the quadriceps
Time frame: Through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 31893349Toselli 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. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.
- Background: PubMed 28355375Tamura 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 Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.
- Background: PubMed 32429802Kim SR, Kim HN, Song SW. Associations Between Mental Health, Quality of Life, and Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. 2020 Sep;18(7):347-352. doi: 10.1089/met.2020.0028. Epub 2020 May 19.
- Individual participant dataSharing planned: Yes. The protocole, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie VIDAL-JESSEL, MD study director
Hopital Forcilles
Andreia GOMES LOPES, MSc principal investigator
Hopital Forcilles
Aymeric Le Neindre, PhD study chair
Hopital Forcilles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hopital Forcilles at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between structural alteration of the quadriceps and quality of life in obese patients (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05467020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.