Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04181944 |
| Other study ID # |
SCDFit |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 14, 2020 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Memorial Healthcare System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
