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

December 13, 2025 updated by: Hospices Civils de Lyon

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Lyon, France, 69003
        • Hopital Edouard Herriot

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surface Electromyography (EMG) Activity
Time Frame: Day 1
Surface EMG signals will be recorded by non-invasive electrodes on the dominant leg.
Day 1
Muscle oxygenation measurement
Time Frame: Day 1
oxyhemoglobin (HbO2) and deoxyhemoglobin (HHb) levels will be measured using Near-Infrared spectroscopy on the dominant leg.
Day 1
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).
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giovanna CANNAS, MD, Hospices Civils de Lyon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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