The Predictive Capacity of Peripheral Muscle Function on Quality of Life Impairment at 1 Year in Subjects With Obesity

NCT05479396 | Completed DMC

• 1 other identifier: 2022-A00132-41
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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 appears to be responsible for impaired muscle function. This causal link is probably linked 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. These changes in the obese patient could be predictive of reduced quality of life. To our knowledge, no study has evaluated the predictive capacity of muscle alteration assessed by ultrasound on the medium-term quality of life of obese patients. The main objective of this study is to evaluate the predictive capacity of structural alteration of the quadriceps on the decrease in quality of life at 1 year in patients with obesity. The secondary objectives are to assess the association between :

• Grip strength and quality of life at 1 year;
• Quadriceps muscle strength and quality of life at 1 year;
• Ultrasound measurements of the quadriceps and quality of life at 1 year;
• Ultrasound measurements of the quadriceps and autonomy at 1 year;
• Grip strength and autonomy at 1 year. This is a prospective, monocenter, observationnal and cohort study. All outpatients for nutrition assessment will be included.

Conditions

Obesity

Keywords

muscle assessment; ultrasonography; quality of live

Outcome Measures

Primary Outcomes (1)

• Evaluate the predictive capacity of structural alteration of the quadriceps on the decrease in quality of life at 1 year in patients with obesity

  The main outcome is the predictive ability of the femoral rectus muscle echogenicity in the gray scale on the 36-Item Short Form Survey (SF-36) score at 1 year

  Through study completion, an average of 22 months

Secondary Outcomes (6)

• Association between grip strength and quality of life at 1 year

  Through study completion, an average of 22 months

• Association between quadriceps muscle strength and quality of life at 1 year

  Through study completion, an average of 22 months

• Association between ultrasound measurements of the quadriceps and quality of life at 1 year

  Through study completion, an average of 22 months

• Association between grip strength and independence at 1 year

  Through study completion, an average of 22 months

• Association between quadriceps muscle strength and autonomy at 1 year

  Through study completion, an average of 22 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients assessment nutrition will be recruited prospectively and consecutively

You may qualify if:

• Outpatients assessment Nutrition
• Obese patients (BMI \> 30);
• Affiliation with a social security scheme or beneficiary of such a scheme ;
• Oral, free, informed and express consent of the patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, 77150, France

Location

Related Publications (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 Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.

  PMID: 28355375 BACKGROUND

• 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.

  PMID: 31893349 BACKGROUND

• Tomlinson DJ, Erskine RM, Winwood K, Morse CI, Onambele GL. The impact of obesity on skeletal muscle architecture in untrained young vs. old women. J Anat. 2014 Dec;225(6):675-84. doi: 10.1111/joa.12248. Epub 2014 Oct 14.

  PMID: 25315680 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie VIDAL-JESSEL, MD

  Hopital Forcilles

  STUDY DIRECTOR

• Andreia GOMES LOPES, MSc

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• Aymeric Le Neindre

  Hopital Forcilles

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 29, 2022
• Study Start: April 22, 2022
• Primary Completion: July 10, 2023
• Study Completion: February 5, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At publication for 10 years
• Access Criteria: The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Locations

FR (1)