Multiple SclerosisOXYSEPNCT06083194
Evaluation of Muscle Oxidative Capacity Relationship With Muscular Endurance, Fatigue (Multiple Sclerosis).
An observational study of Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2024to Jun 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand, 63000
Lise LACLAUTRE, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Frédéric COSTES, fcostes@chu-clermontferrand.fr
About this study
Official title: Non-invasive Evaluation of Muscle Oxidative Capacity. Study of Its Relationship With Muscular Endurance and Fatigue in Patients With Multiple Sclerosis
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.
Read the detailed description
Following an arterial occlusion, the rate of decay of the NIRS signal is only dependent on local O2 consumption. Following an exercise increasing the oxygen consumption of the muscle (isometric contractions for 10 to 15 s), carrying out a series of brief occlusions makes it possible to calculate mVO2 (slope of O2 desaturation at each occlusion). mVO2 decreases exponentially with time, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Furthermore, it has been shown that kNIRS correlates with mitochondrial respiration rate measured in oxygraphy (Ryan et al., 2014).
A few studies have focused on the link between maximal muscular oxidative capacity (mVO2), fatigue and muscular endurance in patients with MS. Furthermore, contradictory results have been reported regarding mVO2 in this population, suggesting in one case a higher mVO2 compared to healthy subjects while others observe the opposite. This results in an imprecise assessment of maximum muscle oxidative capacity (mVO2) in MS patients and its relationship with fatigue and muscular endurance in this population. The investigator therefore propose to carry out a prospective interventional study to analyze the relationship between these different parameters. The investigator's hypothesis is the existence of a positive correlation between mVO2 and muscular endurance, and negative with fatigue. This relationship will also be sought 6 months after participants engagement in regular physical activity. Given the accumulation of functional deficits, this approach is focused on preventive medicine, and with the aim of improving the care of these patients.
The statistical analyzes will be carried out with Stata software (version 15; StataCorp, College Station, Texas, USA), considering a risk of two-sided first type error of 5%.
Continuous variables will be presented in the form of mean and standard deviation, according to the normality of their distribution (Shapiro-Wilk test if necessary). In case of non-normality, they will be presented in the form of median, quartiles and extreme values. Qualitative variables will be expressed in numbers and associated percentages.
Graphical representations will, as much as possible, be associated with these analyses.
A description of the deviations from the protocol, the patients distributed according to these deviations and the causes of abandonment will also be carried out. The number of patients included and the inclusion curve will be presented by group.
Patients will be described at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and possible treatments.
The main analysis aiming to investigate the association between maximum muscle oxidative capacity (mVO2) of MS patients assessed by near-infrared spectroscopy (NIRS) and muscular endurance of the gastrocnemius muscles assessed with the unipedal plantar flexion test (Single- Leg standing Heel Raise Test (SLSHR)) will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution), interpreted with regard to the recommendations reported in the literature.
The main analysis could be supplemented by a multivariate analysis aimed at taking into account possible confounding factors (including form/type of MS, functional deficits and age); a multiple linear regression will be proposed. The normality of the residuals will be studied; if necessary, a transformation (for example logarithmic) of the dependent variable of the study may be proposed). The results will then be expressed in terms of regression coefficients and 95% confidence interval. A subgroup analysis of the main analysis will be carried out (if possible), according to age, MS, and functional deficits; which will make it possible to evaluate the robustness of the results with regard to the heterogeneity of the sample under study and the possible impact of these variables in addition to the aforementioned multivariate analysis. The maximum muscular oxidative capacity and the muscular endurance of the gastrocnemius muscles could, secondly, be treated and analyzed as categorical data with regard to the work reported in the literature; the study of their relationship will then be analyzed by the most appropriate statistical test. For the study of the relationship between two categorical variables, a chi2 test or a Fisher exact test will be confirmed by presenting the results in terms of absolute difference and 95% confidence interval. The secondary analyzes aiming to study the relationship between the maximum muscular oxidative capacity, the fatigue (FACIT-F questionnaire) and the walking capacity will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution) and will be interpreted with regard to the recommendations reported in the literature. The variation in mVO2 at 6 months following the engagement in physical activity [assessed by the variation in energy expenditure (number of METs per week)] will be studied by the paired Student test or the Wilcoxon test; Results will be expressed in terms of effect size and 95% confidence interval.
- 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
- Medical subject headings
- Multiple Sclerosis, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal muscle oxidative capacity (mVO2)
Maximal muscle oxidative capacity will be measured by near-infrared spectroscopy (NIRS)
Measured: 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.
Measured: At the beginning of the protocol inclusion day (to) and at 6 months (t1)
Secondary outcomes (22)
Expanded Disability Status Scale (EDSS)
Medical information about the degree of disability patients with Multiple Sclerosis (MS) using the EDSS score; varying between (0 -10). Higher the value higher the disability.
Measured: At the beginning of the protocol inclusion day (to)
Weight (Kg)
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Height (cm)
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Waist circumference (cm)
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Hip circumference (cm)
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Body Mass Index (Kg/m²)
BMI will be calculated (weight in kilograms divided by height in meters squared).
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Body composition
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Thickness of subcutaneous adipose tissue of the gastrocnemius muscles (mm)
the measure will be performed using a portable ultrasound machine (Sonobook 6 (CHISON Medical Technologies Co., Ltd.) with a linear probe (40 MHz - 150MHz Linear L7-V). The patient will be in a standing position with the foot placed on a stool so that the thigh is parallel to the ground and the knee joint forms a 90° angle.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Functional capacity
Functional capacity will be evaluated using the 6-minute walk test.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Gastrocnemius muscle endurance (number of repetitions and time(sec))
Muscular endurance of the gastrocnemius muscles will be measured with theSingle-Leg Heel Raise Test. Number of repetition will be recorded as well as the time to failure.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Energy expenditure level (MET/minute/week)
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Functional Assessment of Chronic Illness Therapy Fatigue Scale
The degree of fatigue will be evaluated with the FACIT-F Questionnaire. Score varying between 0 to 52. Higher the score higher the fatigue.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
VO2max (maximal oxygen consumption) (mL/Kg/min)
: VO2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Maximum power (Watts)
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Threshold power (Watts)
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Maximum heart rate (bpm)
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Threshold heart rate (bpm)
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Forced vital Capacity (L and % of the theoretical value)
Forced vital Capacity will be measured with a spirometry test
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Forced Expiratory volume (L and % of the theoretical value)
Forced Expiratory volume will be measured with a spirometry test
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Tiffeneau ratio (%)
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Ventilatory reserve (%)
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Tissue saturation index (kNIRS, min-1)
For the determination of mVO2 The patient will be lying down, a cuff (Hokanson SC 12L) will be placed at the level of the thigh, 2 cm from the upper edge of the patella. The NIRS sensor (Portamon, Artinis, Netherlands) will be positioned opposite the body of the two gastrocnemius at the level of its maximum arch, maintained and protected from ambient light by an elastic bandage. The calculation of the absorbances at the 2 wavelengths will be carried out by specific software (Oxysoft) making it possible to display in real time the relative concentrations of Hb and HbO2 and the tissue oxygen saturation (TSI) reflecting muscle O2 saturation.
Measured: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start14 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fréderic COSTES, Principal investigator, fcostes@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083194
- Sponsor's protocol ID
- RBHP 2023 COSTES
- Acronym
- OXYSEP
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adami A, Rossiter HB. Principles, insights, and potential pitfalls of the noninvasive determination of muscle oxidative capacity by near-infrared spectroscopy. J Appl Physiol (1985). 2018 Jan 1;124(1):245-248. doi: 10.1152/japplphysiol.00445.2017. Epub 2017 Jul 6. No abstract available.
PubMed 28684592Boushel R, Piantadosi CA. Near-infrared spectroscopy for monitoring muscle oxygenation. Acta Physiol Scand. 2000 Apr;168(4):615-22. doi: 10.1046/j.1365-201x.2000.00713.x.
PubMed 10759598Edwards T, Pilutti LA. The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Mult Scler Relat Disord. 2017 Aug;16:31-39. doi: 10.1016/j.msard.2017.06.003. Epub 2017 Jun 12.
PubMed 28755682Fromont A, Binquet C, Sauleau EA, Fournel I, Bellisario A, Adnet J, Weill A, Vukusic S, Confavreux C, Debouverie M, Clerc L, Bonithon-Kopp C, Moreau T. Geographic variations of multiple sclerosis in France. Brain. 2010 Jul;133(Pt 7):1889-99. doi: 10.1093/brain/awq134. Epub 2010 Jun 15.
PubMed 20551111Gelfand JM. Multiple sclerosis: diagnosis, differential diagnosis, and clinical presentation. Handb Clin Neurol. 2014;122:269-90. doi: 10.1016/B978-0-444-52001-2.00011-X.
PubMed 24507522Hansen D, Feys P, Wens I, Eijnde BO. Is walking capacity in subjects with multiple sclerosis primarily related to muscle oxidative capacity or maximal muscle strength? A pilot study. Mult Scler Int. 2014;2014:759030. doi: 10.1155/2014/759030. Epub 2014 Jan 29.
PubMed 24624296Harp MA, McCully KK, Moldavskiy M, Backus D. Skeletal muscle mitochondrial capacity in people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316678020. doi: 10.1177/2055217316678020. eCollection 2016 Jan-Dec.
PubMed 28607744Janardhan V, Bakshi R. Quality of life in patients with multiple sclerosis: the impact of fatigue and depression. J Neurol Sci. 2002 Dec 15;205(1):51-8. doi: 10.1016/s0022-510x(02)00312-x.
PubMed 12409184Kent-Braun JA, Ng AV, Castro M, Weiner MW, Gelinas D, Dudley GA, Miller RG. Strength, skeletal muscle composition, and enzyme activity in multiple sclerosis. J Appl Physiol (1985). 1997 Dec;83(6):1998-2004. doi: 10.1152/jappl.1997.83.6.1998.
PubMed 9390973Kent-Braun JA, Sharma KR, Miller RG, Weiner MW. Postexercise phosphocreatine resynthesis is slowed in multiple sclerosis. Muscle Nerve. 1994 Aug;17(8):835-41. doi: 10.1002/mus.880170802.
PubMed 8041390Malagoni AM, Felisatti M, Lamberti N, Basaglia N, Manfredini R, Salvi F, Zamboni P, Manfredini F. Muscle oxygen consumption by NIRS and mobility in multiple sclerosis patients. BMC Neurol. 2013 May 29;13:52. doi: 10.1186/1471-2377-13-52.
PubMed 23718840Manago MM, Kline PW, Harris-Love MO, Christiansen CL. The Validity of the Single-Leg Heel Raise Test in People With Multiple Sclerosis: A Cross-Sectional Study. Front Neurol. 2021 Jul 21;12:650297. doi: 10.3389/fneur.2021.650297. eCollection 2021.
PubMed 34354656Motl RW, McAuley E, Sandroff BM, Hubbard EA. Descriptive epidemiology of physical activity rates in multiple sclerosis. Acta Neurol Scand. 2015 Jun;131(6):422-5. doi: 10.1111/ane.12352. Epub 2015 Jan 18.
PubMed 25598210Nagaraj K, Taly AB, Gupta A, Prasad C, Christopher R. Prevalence of fatigue in patients with multiple sclerosis and its effect on the quality of life. J Neurosci Rural Pract. 2013 Jul;4(3):278-82. doi: 10.4103/0976-3147.118774.
PubMed 24250159N'Guessan B, Zoll J, Ribera F, Ponsot E, Lampert E, Ventura-Clapier R, Veksler V, Mettauer B. Evaluation of quantitative and qualitative aspects of mitochondrial function in human skeletal and cardiac muscles. Mol Cell Biochem. 2004 Jan-Feb;256-257(1-2):267-80. doi: 10.1023/b:mcbi.0000009874.14649.ca.
PubMed 14977187
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Muscle Oxidative Capacity. Study of Its Relationship With Muscular Endurance and Fatigue in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06083194
- Acronym / sponsor ID
- OXYSEP / RBHP 2023 COSTES
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
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.
Detailed description
Following an arterial occlusion, the rate of decay of the NIRS signal is only dependent on local O2 consumption. Following an exercise increasing the oxygen consumption of the muscle (isometric contractions for 10 to 15 s), carrying out a series of brief occlusions makes it possible to calculate mVO2 (slope of O2 desaturation at each occlusion). mVO2 decreases exponentially with time, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Furthermore, it has been shown that kNIRS correlates with mitochondrial respiration rate measured in oxygraphy (Ryan et al., 2014).
A few studies have focused on the link between maximal muscular oxidative capacity (mVO2), fatigue and muscular endurance in patients with MS. Furthermore, contradictory results have been reported regarding mVO2 in this population, suggesting in one case a higher mVO2 compared to healthy subjects while others observe the opposite. This results in an imprecise assessment of maximum muscle oxidative capacity (mVO2) in MS patients and its relationship with fatigue and muscular endurance in this population. The investigator therefore propose to carry out a prospective interventional study to analyze the relationship between these different parameters. The investigator's hypothesis is the existence of a positive correlation between mVO2 and muscular endurance, and negative with fatigue. This relationship will also be sought 6 months after participants engagement in regular physical activity. Given the accumulation of functional deficits, this approach is focused on preventive medicine, and with the aim of improving the care of these patients.
The statistical analyzes will be carried out with Stata software (version 15; StataCorp, College Station, Texas, USA), considering a risk of two-sided first type error of 5%.
Continuous variables will be presented in the form of mean and standard deviation, according to the normality of their distribution (Shapiro-Wilk test if necessary). In case of non-normality, they will be presented in the form of median, quartiles and extreme values. Qualitative variables will be expressed in numbers and associated percentages.
Graphical representations will, as much as possible, be associated with these analyses.
A description of the deviations from the protocol, the patients distributed according to these deviations and the causes of abandonment will also be carried out. The number of patients included and the inclusion curve will be presented by group.
Patients will be described at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and possible treatments.
The main analysis aiming to investigate the association between maximum muscle oxidative capacity (mVO2) of MS patients assessed by near-infrared spectroscopy (NIRS) and muscular endurance of the gastrocnemius muscles assessed with the unipedal plantar flexion test (Single- Leg standing Heel Raise Test (SLSHR)) will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution), interpreted with regard to the recommendations reported in the literature.
The main analysis could be supplemented by a multivariate analysis aimed at taking into account possible confounding factors (including form/type of MS, functional deficits and age); a multiple linear regression will be proposed. The normality of the residuals will be studied; if necessary, a transformation (for example logarithmic) of the dependent variable of the study may be proposed). The results will then be expressed in terms of regression coefficients and 95% confidence interval. A subgroup analysis of the main analysis will be carried out (if possible), according to age, MS, and functional deficits; which will make it possible to evaluate the robustness of the results with regard to the heterogeneity of the sample under study and the possible impact of these variables in addition to the aforementioned multivariate analysis. The maximum muscular oxidative capacity and the muscular endurance of the gastrocnemius muscles could, secondly, be treated and analyzed as categorical data with regard to the work reported in the literature; the study of their relationship will then be analyzed by the most appropriate statistical test. For the study of the relationship between two categorical variables, a chi2 test or a Fisher exact test will be confirmed by presenting the results in terms of absolute difference and 95% confidence interval. The secondary analyzes aiming to study the relationship between the maximum muscular oxidative capacity, the fatigue (FACIT-F questionnaire) and the walking capacity will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution) and will be interpreted with regard to the recommendations reported in the literature. The variation in mVO2 at 6 months following the engagement in physical activity [assessed by the variation in energy expenditure (number of METs per week)] will be studied by the paired Student test or the Wilcoxon test; Results will be expressed in terms of effect size and 95% confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Maximal muscle oxidative capacity (mVO2)
Time frame: At the beginning of the protocol inclusion day (to) and at 6 months (t1)
Maximal muscle oxidative capacity will be measured by near-infrared spectroscopy (NIRS)
Muscular endurance of the gastrocnemius muscles
Time frame: At the beginning of the protocol inclusion day (to) and at 6 months (t1)
Muscular endurance of the gastrocnemius muscles, represented by the number of repetitions measured with the Single-Leg Heel Raise Test.
22 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: At the beginning of the protocol inclusion day (to)
Weight (Kg)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Height (cm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Waist circumference (cm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Hip circumference (cm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Body Mass Index (Kg/m²)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Body composition
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Thickness of subcutaneous adipose tissue of the gastrocnemius muscles (mm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Functional capacity
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Gastrocnemius muscle endurance (number of repetitions and time(sec))
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Energy expenditure level (MET/minute/week)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Functional Assessment of Chronic Illness Therapy Fatigue Scale
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
VO2max (maximal oxygen consumption) (mL/Kg/min)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Maximum power (Watts)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Threshold power (Watts)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Maximum heart rate (bpm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Threshold heart rate (bpm)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Forced vital Capacity (L and % of the theoretical value)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Forced Expiratory volume (L and % of the theoretical value)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Tiffeneau ratio (%)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Ventilatory reserve (%)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Tissue saturation index (kNIRS, min-1)
Time frame: At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 28684592Adami A, Rossiter HB. Principles, insights, and potential pitfalls of the noninvasive determination of muscle oxidative capacity by near-infrared spectroscopy. J Appl Physiol (1985). 2018 Jan 1;124(1):245-248. doi: 10.1152/japplphysiol.00445.2017. Epub 2017 Jul 6. No abstract available.
- Background: PubMed 10759598Boushel R, Piantadosi CA. Near-infrared spectroscopy for monitoring muscle oxygenation. Acta Physiol Scand. 2000 Apr;168(4):615-22. doi: 10.1046/j.1365-201x.2000.00713.x.
- Background: PubMed 28755682Edwards T, Pilutti LA. The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Mult Scler Relat Disord. 2017 Aug;16:31-39. doi: 10.1016/j.msard.2017.06.003. Epub 2017 Jun 12.
- Background: PubMed 20551111Fromont A, Binquet C, Sauleau EA, Fournel I, Bellisario A, Adnet J, Weill A, Vukusic S, Confavreux C, Debouverie M, Clerc L, Bonithon-Kopp C, Moreau T. Geographic variations of multiple sclerosis in France. Brain. 2010 Jul;133(Pt 7):1889-99. doi: 10.1093/brain/awq134. Epub 2010 Jun 15.
- Background: PubMed 24507522Gelfand JM. Multiple sclerosis: diagnosis, differential diagnosis, and clinical presentation. Handb Clin Neurol. 2014;122:269-90. doi: 10.1016/B978-0-444-52001-2.00011-X.
- Background: PubMed 24624296Hansen D, Feys P, Wens I, Eijnde BO. Is walking capacity in subjects with multiple sclerosis primarily related to muscle oxidative capacity or maximal muscle strength? A pilot study. Mult Scler Int. 2014;2014:759030. doi: 10.1155/2014/759030. Epub 2014 Jan 29.
- Background: PubMed 28607744Harp MA, McCully KK, Moldavskiy M, Backus D. Skeletal muscle mitochondrial capacity in people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316678020. doi: 10.1177/2055217316678020. eCollection 2016 Jan-Dec.
- Background: PubMed 12409184Janardhan V, Bakshi R. Quality of life in patients with multiple sclerosis: the impact of fatigue and depression. J Neurol Sci. 2002 Dec 15;205(1):51-8. doi: 10.1016/s0022-510x(02)00312-x.
- Background: PubMed 9390973Kent-Braun JA, Ng AV, Castro M, Weiner MW, Gelinas D, Dudley GA, Miller RG. Strength, skeletal muscle composition, and enzyme activity in multiple sclerosis. J Appl Physiol (1985). 1997 Dec;83(6):1998-2004. doi: 10.1152/jappl.1997.83.6.1998.
- Background: PubMed 8041390Kent-Braun JA, Sharma KR, Miller RG, Weiner MW. Postexercise phosphocreatine resynthesis is slowed in multiple sclerosis. Muscle Nerve. 1994 Aug;17(8):835-41. doi: 10.1002/mus.880170802.
- Background: PubMed 23718840Malagoni AM, Felisatti M, Lamberti N, Basaglia N, Manfredini R, Salvi F, Zamboni P, Manfredini F. Muscle oxygen consumption by NIRS and mobility in multiple sclerosis patients. BMC Neurol. 2013 May 29;13:52. doi: 10.1186/1471-2377-13-52.
- Background: PubMed 34354656Manago MM, Kline PW, Harris-Love MO, Christiansen CL. The Validity of the Single-Leg Heel Raise Test in People With Multiple Sclerosis: A Cross-Sectional Study. Front Neurol. 2021 Jul 21;12:650297. doi: 10.3389/fneur.2021.650297. eCollection 2021.
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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.
Fréderic COSTES principal investigator
fcostes@chu-clermontferrand.fr
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 Multiple Sclerosis, run by University Hospital, Clermont-Ferrand 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 8 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal muscle oxidative capacity (mVO2) (time frame: At the beginning of the protocol inclusion day (to) and at 6 months (t1)). The study lists 2 primary outcomes in all. 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 NCT06083194, which also lists 28 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 17 Jan 2024.