Evaluation of Muscle Oxidative Capacity Relationship With Muscular Endurance, Fatigue (Multiple Sclerosis).

NCT06083194 | Unknown

• 1 other identifier: RBHP 2023 COSTES
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is characterized by different progressive forms with periods of flare-ups interspersed with phases of remission. MS manifests clinically with signs of multiple neurological dysfunctions as well as less specific symptoms such as fatigue, the prevalence of which is found to be high in these patients and is independently associated with an alteration in their quality of life. Recently, a non-invasive method for assessing maximal muscle oxidative capacity (mVO2) using optical measurement of muscle oxygenation (near-infrared spectroscopy, NIRS) has been described. Measuring tissue light absorption from a skin sensor facing a muscle, makes it possible to distinguish tissue concentrations of oxyhemoglobin (HbO2) and hemoglobin (Hb). The difference in absorbance of Hb and HbO2 corresponds to the balance of O2 supply and consumption in tissue capillaries, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Current literature provides reference values in young healthy subjects and MS patients. This index could therefore constitute a particularly interesting non-invasive indicator of mitochondrial functioning, usable in the clinic.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Near infrared spectroscopy (NIRS); Physical capacities; Fatigue; Muscle oxidative capacity; Skeletal muscle mitochondrial capacity; Muscle oxygen consumption; Single-Leg Heel Raise Test; Endurance

Outcome Measures

Primary Outcomes (2)

• Maximal muscle oxidative capacity (mVO2)

  Maximal muscle oxidative capacity will be measured by near-infrared spectroscopy (NIRS)

  At the beginning of the protocol inclusion day (to) and at 6 months (t1)

• Muscular endurance of the gastrocnemius muscles

  Muscular endurance of the gastrocnemius muscles, represented by the number of repetitions measured with the Single-Leg Heel Raise Test.

  At the beginning of the protocol inclusion day (to) and at 6 months (t1)

Secondary Outcomes (22)

• Expanded Disability Status Scale (EDSS)

  At the beginning of the protocol inclusion day (to)

• Weight (Kg)

  At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)

• Height (cm)

  At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)

• Waist circumference (cm)

  At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)

• Hip circumference (cm)

  At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Sclerosis with a Kurtzke Expanded Disability Status Scale (EDSS) score \< 5 prospectively assesed for muscle oxidative capacity and muscle endurance.

You may qualify if:

• Patients with Multiple Sclerosis (MS) with a diagnosis established by MRI.
• Patients with a Kurtzke Expanded Disability Status Scale (EDSS) score \< 5.
• Body mass index (BMI) \< 30 Kg/m².
• Thickness of subcutaneous adipose tissue at the calf ≤ 20 mm.
• MS patients without neurological signs of flare-up since 1 month.
• MS patients who have not had any treatment modification during the last 2 months.
• Subjects affiliated to French health care system (for France).
• Volunteers who have given their written consent.

You may not qualify if:

• Patients suffering from progressive psychiatric pathologies (active psychosis, , etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
• People with poorly controlled or unstable cardiovascular disease.
• Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
• Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
• Pregnant or lactating women.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fréderic COSTES

  fcostes@chu-clermontferrand.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: January 14, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-10

Locations

FR (1)