Sickle Cell DiseaseDREPAMUSCLENCT03243812
Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease
A study testing Blood sampling, Maximum Voluntary Contraction (MVC) test force and Localized muscle endurance test in people with Sickle Cell Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Blood sampling, Maximum Voluntary Contraction (MVC) test force and Localized muscle endurance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2017to 13 Dec 2019
- Phase
- Interventional
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sickle Cell Disease
- Being tested
- Blood sampling, Maximum Voluntary Contraction (MVC) test force, Localized muscle endurance test, Self-paced six-minute walk test
- Keywords
- Sickle Cell Disease, Muscle function, Hemorheological disorders
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling will be performed to assess hematological and hemorheological parameters
Maximum Voluntary Contraction (MVC) test forceOther
Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
Localized muscle endurance testOther
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 testOther
Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
| Study group | Role | What they receive |
|---|---|---|
| SS genotype group | Active comparator | 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 Receives: Biological: Blood sampling; Other: Maximum Voluntary Contraction (MVC) test force; Other: Localized muscle endurance test; Other: Self-paced six-minute walk test |
| SC genotype group | Active comparator | 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 Receives: Biological: Blood sampling; Other: Maximum Voluntary Contraction (MVC) test force; Other: Localized muscle endurance test; Other: Self-paced six-minute walk test |
| control group | Active comparator | 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 Receives: Biological: Blood sampling; Other: Maximum Voluntary Contraction (MVC) test force; Other: Localized muscle endurance test; Other: Self-paced six-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum isometric muscular strength
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.
Measured: Day 1
Secondary outcomes (10)
Surface Electromyography (EMG) Activity
Surface EMG signals will be recorded by non-invasive electrodes on the dominant leg.
Measured: Day 1
Muscle oxygenation measurement
oxyhemoglobin (HbO2) and deoxyhemoglobin (HHb) levels will be measured using Near-Infrared spectroscopy on the dominant leg.
Measured: Day 1
Measurement of six-minute walk distance (6MWD)
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).
Measured: Day 1
Complete Blood Count (CBC)
CBC will be performed in order to evaluate the role of hematological disorders in the muscle fatigue of sickle cell patients.
Measured: Day 1
Hematocrit
Hematocrit will be measured in order to evaluate the role of hematological disorders in the muscle fatigue of sickle cell patients.
Measured: Day 1
Blood viscosity
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.
Measured: Day 1
Red blood cell (RBC) deformability
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.
Measured: Day 1
Aggregation properties
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.
Measured: Day 1
Hemoglobin oxygenation level
Hemoglobin oxygenation level will be measured in order to evaluate the role of hemorheological disorders in the muscle fatigue of sickle cell patients.
Measured: Day 1
Number of vaso-occlusive crises and acute chest syndrome within a 5 years retrospective period.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start15 Sep 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna CANNAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243812
- Sponsor's protocol ID
- 69HCL17_0313
- Acronym
- DREPAMUSCLE
- Status last verified
- Dec 2025
- First submitted
- 27 Jul 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34067352
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03243812
- Acronym / sponsor ID
- DREPAMUSCLE / 69HCL17_0313
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Muscle function, Hemorheological disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 9 Aug 2017 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SS genotype group | Active comparator | Biological: Blood sampling, Other: Maximum Voluntary Contraction (MVC) test force, Other: Localized muscle endurance test, Other: Self-paced six-minute walk testSickle 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 |
| SC genotype group | Active comparator | Biological: Blood sampling, Other: Maximum Voluntary Contraction (MVC) test force, Other: Localized muscle endurance test, Other: Self-paced six-minute walk testSickle 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 |
| control group | Active comparator | Biological: Blood sampling, Other: Maximum Voluntary Contraction (MVC) test force, Other: Localized muscle endurance test, Other: Self-paced six-minute walk testHealthy 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 |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- other hemoglobinopathies,
- stroke or vasculopathy history,
- presence of leg ulcers or osteonecrosis,
- recent infectious episode (less than 1 month),
- chronic transfusion therapy programs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling will be performed to assess hematological and hemorheological parameters | Biological | SC genotype group, SS genotype group, control group |
| Maximum Voluntary Contraction (MVC) test forceMaximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test | Other | SC genotype group, SS genotype group, control group |
| Localized muscle endurance testSubject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery. | Other | SC genotype group, SS genotype group, control group |
| Self-paced six-minute walk testSelf-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society | Other | SC genotype group, SS genotype group, control group |
Primary outcome
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.
10 secondary outcomes
Surface Electromyography (EMG) Activity
Time frame: Day 1
Muscle oxygenation measurement
Time frame: Day 1
Measurement of six-minute walk distance (6MWD)
Time frame: Day 1
Complete Blood Count (CBC)
Time frame: Day 1
Hematocrit
Time frame: Day 1
Blood viscosity
Time frame: Day 1
Red blood cell (RBC) deformability
Time frame: Day 1
Aggregation properties
Time frame: Day 1
Hemoglobin oxygenation level
Time frame: Day 1
Number of vaso-occlusive crises and acute chest syndrome within a 5 years retrospective period.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 34067352Gouraud 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.
- Individual participant dataSharing planned: No
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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.
Giovanna CANNAS, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Maximum Voluntary Contraction (MVC) test force and Localized muscle endurance test in people with Sickle Cell Disease, run by Hospices Civils de Lyon 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum isometric muscular strength (time frame: Day 1). 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 NCT03243812, which also lists 1 linked publication.
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 19 Dec 2025.