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Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease (DREPAMUSCLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243812
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Background : Sickle cell patients have profound remodeling of their muscle microcirculation networks with signs of amyotrophy. However, the consequences of these muscle alterations on the functional status of muscles are unknown. In addition, whether the poor physical fitness of sickle cell patients can be attributed, at least partly, to an hypothetical muscle dysfunction has never been tested.

Purpose : this study will compare the muscle function of legs between sickle cell patients (SS and SC genotypes) and healthy individuals (AA genotype) before, during and after a short localized muscle endurance exercise.

Abstract : Very recently, a study reported large differences between the muscle microcirculation networks of sickle cell patients compared to healthy individuals with decreased capillary density and higher proportion of large capillaries in the former population. In addition, the same study showed signs of amyotrophy in sickle cell patients. However, the muscle function of sickle cell patients has not been investigated and one may suggest that muscle dysfunction could participate in the decrease of physical fitness, in association with the hematological and hemorheological disorders, already reported in this population. The hypothesis is that muscle fatigue during a short localized muscle endurance exercise should be higher in sickle cell patients compared to healthy individuals, due to a greater recruitment of glycolytic fibers and a faster decrease of muscle oxygenation during exercise.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Biological: Blood sampling Other: Maximum Voluntary Contraction (MVC) test force Other: Localized muscle endurance test Other: Self-paced six-minute walk test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SS genotype group

Sickle cell patients with SS genotype. Each subject will undergo the following :

  1. Blood sample
  2. Maximum Voluntary Contraction (MVC) test force before and after a localized muscle endurance test
  3. Localized muscle endurance test: 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
  4. Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
 Biological: Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters

Other: Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test

Other: Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.

Other: Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
Active Comparator: SC genotype group

Sickle cell patients with SC genotype. Each subject will undergo the following :

  1. Blood sample
  2. Maximum Voluntary Contraction (MVC) test force before and after a localized muscle endurance test
  3. Localized muscle endurance test: 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
  4. Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
 Biological: Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters

Other: Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test

Other: Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.

Other: Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
Active Comparator: control group

Healthy subjects. Each subject will undergo the following :

  1. Blood sample
  2. Maximum Voluntary Contraction (MVC) test force before and after a localized muscle endurance test
  3. Localized muscle endurance test: 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
  4. Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
 Biological: Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters

Other: Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test

Other: Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.

Other: Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society


Outcome Measures
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Primary Outcome Measures :
  1. Maximum isometric muscular strength [ Time Frame: Day 1 ]

    Isometric muscular strength will be determined by Maximum Voluntary Contraction (MVC) test force on dominant leg.

    Muscular function will be evaluated using Maximum Voluntary Contraction (MVC) test force and the muscle endurance ability, which will be highlighted by the degree of decline of MVC after a short localized muscle effort using the formula: ((post MVC force - pre MVC force) / pre MVC force)x100.

    Muscle weakness will be determined by a loss of maximum isometric strength ≥ 20 % compared with control group.



Secondary Outcome Measures :
  1. Surface Electromyography (EMG) Activity [ Time Frame: Day 1 ]
    Surface EMG signals will be recorded by non-invasive electrodes on the dominant leg.

  2. Muscle oxygenation measurement [ Time Frame: Day 1 ]
    oxyhemoglobin (HbO2) and deoxyhemoglobin (HHb) levels will be measured using Near-Infrared spectroscopy on the dominant leg.

  3. Measurement of six-minute walk distance (6MWD) [ Time Frame: Day 1 ]

    In order to investigate the association between muscle endurance ability and physical fitness in sickle cell patients, patients will realize a six-minute walk test (6MWT).

    6MWD will be measured = the distance that a patient has walked on a flat, hard surface in a period of 6 minutes (6MWT).


  4. Complete Blood Count (CBC) [ Time Frame: Day 1 ]
    CBC will be performed in order to evaluate the role of hematological disorders in the muscle fatigue of sickle cell patients.

  5. Hematocrit [ Time Frame: Day 1 ]
    Hematocrit will be measured in order to evaluate the role of hematological disorders in the muscle fatigue of sickle cell patients.

  6. Blood viscosity [ Time Frame: Day 1 ]
    Blood viscosity will be measured by using viscosimetry, in order to evaluate the role of hemorheological disorders in the muscle fatigue of sickle cell patients.

  7. Red blood cell (RBC) deformability [ Time Frame: Day 1 ]
    RBC deformability will be assessed by using ektacytometry, in order to evaluate the role of hemorheological disorders in the muscle fatigue of sickle cell patients.

  8. Aggregation properties [ Time Frame: Day 1 ]
    Aggregation properties will be assessed by using syllectometry, in order to evaluate the role of hemorheological disorders in the muscle fatigue of sickle cell patients.

  9. Hemoglobin oxygenation level [ Time Frame: Day 1 ]
    Hemoglobin oxygenation level will be measured in order to evaluate the role of hemorheological disorders in the muscle fatigue of sickle cell patients.

  10. Number of vaso-occlusive crises and acute chest syndrome within a 5 years retrospective period. [ Time Frame: Day 1 ]

    Number of vaso-occlusive crises and acute chest syndrome reflects of clinical severity of the sickle cell disease.

    Clinical severity will be retrospectively (5 years) collected in clinical record of sickle cell patients.

    These clinical data will be used to study the relationships between the degree of muscle dysfunction and the degree of clinical severity in sickle cell patients.



Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Sickle cell patients :

  • age ≥ 15 and < 60 years old,
  • SS homozygote or SC heterozygote
  • in clinical steady state (i.e. without vaso-occlusive crisis or recent blood transfusion)
  • identified by systematic neonatal screening programs,
  • registered in the French medical social security national program

For Healthy and non sickle cell subjects:

  • age ≥ 18 and < 60 years old
  • without cardiovascular/respiratory/muscle disease,
  • registered in the French medical social security national program.

Exclusion Criteria:

  • other hemoglobinopathies,
  • stroke or vasculopathy history,
  • presence of leg ulcers or osteonecrosis,
  • recent infectious episode (less than 1 month),
  • chronic transfusion therapy programs,
  • recent blood transfusion or phlebotomies (less than 3 months),
  • patients not at steady state,
  • pregnancy or breast feeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243812


Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Giovanna CANNAS, MD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03243812    
Other Study ID Numbers: 69HCL17_0313
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Sickle Cell Disease
Muscle function
Hemorheological disorders
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn