Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients
NCT02571088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-09-13
Summary
Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature reports that SCD patients display intolerance to exercise, important muscle weakness and profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular network.
Because strenuous exercise induces acidosis, hemorheological alterations, endothelial activation and oxidative stress, it constitutes a potential triggering factor of sickling and vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in patients with SCD. However, moderate and regular physical activity seems to be not only safe but also beneficial for SCD patients.
Conditions
- Sickle Cell Hemoglobin C Disease
- Hemoglobin S Disease
Interventions
- OTHER
-
Training Program
Each training session will last 45 min. Exercise will start by a 5-min warm-up cycling period, followed by 30 min of cycling at the power output (W) individually determined before and corresponding to the first lactate threshold corresponding approximately to 2.5 mmol/l . Then patients will cool down for 5 min. Finally, the training sessions will end by 5 min of light stretching. All training sessions will take place at the hospital and will be under the supervision of a physician. Heart rate, oxygen saturation and blood lactate concentrations will be regularly measured. Work rate will be adjusted according to the obtained results. As a safety procedure, blood lactate concentration must not exceed 4 mmol/L during the training sessions. A particular attention will be paid to the hydration of patients. Pain and fatigue will be evaluated everyday by the patients using (100 mm) visual analog scales.
Sponsors & Collaborators
-
Centre de Référence des Syndromes Drépanocytaires Majeurs
collaborator OTHER -
Laboratoire de Physiologie de l'Exercice
collaborator UNKNOWN -
Claude Bernard University
collaborator OTHER -
Centre Hospitalier Universitaire de Saint Etienne
lead OTHER
Principal Investigators
-
Leonard FEASSON, MD · CHU de SAINT-ETIENNE
-
Laurent MESSONIER, PhD · Université de Savoie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- France
Study Locations
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