Muscle Oxygenation in Effort in Neuromuscular Diseases (OXYNEMU)

April 17, 2026 updated by: University Hospital, Lille

Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment

Previous studies showed modifications of muscle oxygenation parameters in muscular dystrophies du to an impairment or an absence of dystrophin.

Our study aim at assessing muscle oxygenation during effort in different neuromuscular diseases (muscular dystrophies related and not related to dystrophin, non dystrophic myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and controls are invited to perform an inframaximal , standardized effort of the knee extensors by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through a Near Infrared Spectroscopy (NIRS) Device.

In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.

Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular dystrophies compared to other neuromuscular diseases and healthy controls because of lack of muscle capillary vessels dilatation during effort and impairment of mitochondrial function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective physiological study in a pathological condition (neuromuscular diseases).

5 groups of voluntary participants will be investigated:

1. 20 subjects affected by Dystrophin related muscular dystrophy (Becker Muscular Dystrophy ) 2. Subjects affected by muscular dystrophy not related to dystrophin impairment : 20 subjects affected by facioscapulohumeral dystrophy and 20 subjects affected by Limb Girdle Muscular dystrophy 3. 20 subjects affected by non-dystrophic myopathies (Congenital myopathies ) 4. 20 subjects affected by motor diseases: amyotrophic lateral sclerosis(ALS), Charcot Marie Tooth disease, Spinal Muscular Atrophy .

5. 20 healthy controls Objective: asses the muscular oxygenation modifications during a standardized effort and compare the variables between groups. Analyze the mitochondrial function and phenotype in the BMD group compared to healthy controls Outcome : Muscle Oxygenation by Near Infrared Spectroscopy parameters; oxygen consumption, Muscle Function Measure, Vignos and Brooke score, Borg scale, 6 minutes walk test, mitochondrial phenotype, mitochondrial oxygenation 3 visits : 1- inclusion 2- standardized effort protocol 3- for Becker dystrophy patients and voluntary controls, muscle biopsy of the Vastus Lateralis

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Hôpital Amiens Nord, Service de Neurologie
      • Lille, France
        • CHRU de Lille, Hôpital Swyngedhauw
      • Reims, France
        • Hôpital Sébastopol, CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy subjects and
  • subjects affected by one of the fallowing neuromuscular diseases: Becker Muscular dystrophy Facioscapulohumeral dystrophy, Limb Girdle Muscular Dystrophy , Congenital Myopathy , Spinal Muscular Atrophy Charcot Marie Tooth Disease and Amyotrophic Lateral Sclerosis ,
  • able to walk
  • presenting a manual muscle testing of at Least 4/5 on the quadriceps according to the Medical research Council

Exclusion Criteria:

  • musculoskeletal pain of the quadriceps
  • other neurological disorders
  • Heart failure arrhythmia, uncontrolled hypertension, angina pectoris
  • dyspnoea >2 according to the NYHA
  • Peripheral artery disease
  • BMI >30kg.m-2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: muscle oxygenation
assesment of muscle oxygenation and gas exchanges
Other: muscle oxygenation
Subjects will be invited to perform an isokinetic effort of the knee extensors against an isokinetic dynamometer. During this effort, muscle oxygenation and oxygen consumption will be assessed with a near infrared spectroscopy device and a gas exchange measurement device. Patients affected by Becker muscular dystrophy and healthy controls will be invited to have a muscle biopsy of the vastus lateralis.
Other Names:
  • Muscle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle oxygenation
Time Frame: on the day of first evaluation Visit V1
level of deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors
on the day of first evaluation Visit V1
Muscle oxygenation
Time Frame: on the day of first evaluation Visit V1
kinetics of the deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors
on the day of first evaluation Visit V1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal isokinetic strength of the knee extensors
Time Frame: on the day of first evaluation Visit V1
measurements of the maximal moment during a maximal effort of the knee extensors with an isokinetic dynamometer
on the day of first evaluation Visit V1
Gas exchange
Time Frame: on the day of first evaluation Visit V1
measurements of O2 and CO2 exchanges during the isokinetic effort
on the day of first evaluation Visit V1
MFM score
Time Frame: on the day of first evaluation Visit V1
Motor Function Measure score (in %) assessment. quantitative scale that makes it possible to measure the functional motor abilities of a person affected by a neuromuscular disease.
on the day of first evaluation Visit V1
6 Minutes Walking Test (MWT)
Time Frame: on the day of first evaluation Visit V1
assessment of the time performed during a 6 minutes walking test
on the day of first evaluation Visit V1
Vignos functional scales
Time Frame: on the day of first evaluation Visit V1
assesment of the 1 to 6 Vignos score for the lower limb functional assesment
on the day of first evaluation Visit V1
Brooke functional scales
Time Frame: on the day of first evaluation Visit V1
the 1 to 10 Brooke score for upper limb functional assesment
on the day of first evaluation Visit V1
Medical Research Council Muscle testing
Time Frame: on the day of first evaluation Visit V1
Assesment of the Medical Research Council 1 to 5 Muscle testing score of the quadriceps muscles
on the day of first evaluation Visit V1
Mitochondrial phenotype
Time Frame: at V2 at least 1 week after V1
Mitochondrial respiration (O2 consumption) of muscle fibers of the vastus lateralis
at V2 at least 1 week after V1
Mitochondrial H2O2 production
Time Frame: at V2 at least 1 week after V1
Mitochondrial H2O2 production of muscle fibers of the vastus lateralis
at V2 at least 1 week after V1
kinetic of Muscle oxygenation
Time Frame: on the day of first evaluation Visit V1
kinetic of level of deoxyhemoglobin during the isokinetic effort of the extensors of the knee
on the day of first evaluation Visit V1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Vincent Tiffreau, MD, CHRU de Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimated)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_29
  • 2014-A01157-40 (Other Identifier: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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