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Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA) (SCA)

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ClinicalTrials.gov Identifier: NCT04181944
Recruitment Status : Not yet recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Foluso Joy Ogunsile, University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to assess the potential interventions of exercises in adults with sickle cell anemia (SCA) and cardiopulmonary disease; only including the more severe genotypes of sickle cell disease.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Sickle Cell Disease Exercise Other: Exercise Treatment Group Not Applicable

Detailed Description:
Sickle cell disease is an inherited blood disorder that affects approximately 100,000 people in the United States. People living with sickle cell disease have numerous complications that cause significant morbidity and mortality such as painful episodes of vasoocclusion, acute chest syndrome, stroke, end organ damage, and early death. Unfortunately, their lifespan remains markedly shorter than the general population and this had not dramatically changed in the last 2 decades. Adults, are now not dying primarily from infections and sickle cell disease related complications, but cardiopulmonary disease is a leading cause of death. The etiology of cardiopulmonary disease in sickle cell disease is unclear but studies suggest that microvascular hypoxia, inflammation and endothelial dysfunction play a major role in the pathogenesis. In the general population, exercise reduces cardiovascular complications, pulmonary exacerbations, and decreases cardiovascular death. However, exercise used as primary or secondary prevention in sickle cell disease for cardiopulmonary disease has not been explored. Evidence shows that exercise in sickle cell disease can decrease oxidative stress, lower blood viscosity, and increase nitric oxide levels in both human and mouse models, but there remains some concern that high-intensity training in sickle cell disease may trigger vaso-occlusive crisis and adverse outcomes. However, multiple recent studies show that moderate intensity exercise can be safely performed in adults with sickle cell disease. Currently, providers lack evidence-based knowledge to inform the quantity and quality of regular exercise training that is safe but also improves cardiovascular outcomes in sickle cell disease. In addition, data does not exist on the feasibility and adherence of home-based training regimens in adults with sickle cell disease. Only one study has explored the feasibility and adherence in children. This study will be a qualitative assessment of potential interventions of exercises in adults with sickle cell anemia, only including the more severe genotypes of sickle cell disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA)
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : January 15, 2021


Arm Intervention/treatment
Experimental: Exercise Treatment Group Other: Exercise Treatment Group
be specific




Primary Outcome Measures :
  1. Specific exercise regimen for those living with sickle cell disease [ Time Frame: One year ]
    100 participants with sickle cell disease exercise preference based on the survey results, decrease the severity of cardiovascular disease in patients with sickle cell disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older with a known diagnosis of sickle cell anemia
  • Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign a consent form and complete an interview

Exclusion Criteria:

- Subjects who does not meet the inclusion criteria above


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): NCT04181944


Contacts
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Contact: Nicky H Staton 205-975-4017 nsharris@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Contact: Nicky H Staton, BA    205-975-4017    nsharris@uabmc.edu   
Principal Investigator: Joy Ogunsile, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Foluso J Ogunsile, MD University of Alabama at Birmingham

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Responsible Party: Foluso Joy Ogunsile, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04181944    
Other Study ID Numbers: SCDFit
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Cardiovascular Diseases
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn