Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease
NCT ID: NCT03243812
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2017-09-15
2019-12-13
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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
Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters
Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
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
Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters
Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
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
Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters
Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
Interventions
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Blood sampling
Blood sampling will be performed to assess hematological and hemorheological parameters
Maximum Voluntary Contraction (MVC) test force
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
Localized muscle endurance test
Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
Self-paced six-minute walk test
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
60 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Giovanna CANNAS, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital Edouard Herriot
Lyon, , France
Countries
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References
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Gouraud E, Connes P, Gauthier-Vasserot A, Faes C, Merazga S, Poutrel S, Renoux C, Boisson C, Joly P, Bertrand Y, Hot A, Cannas G, Hautier C. Is Skeletal Muscle Dysfunction a Limiting Factor of Exercise Functional Capacity in Patients with Sickle Cell Disease? J Clin Med. 2021 May 22;10(11):2250. doi: 10.3390/jcm10112250.
Other Identifiers
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69HCL17_0313
Identifier Type: -
Identifier Source: org_study_id