Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05228756 |
Other study ID # |
300008284 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2022 |
Est. completion date |
December 1, 2023 |
Study information
Verified date |
October 2022 |
Source |
University of Alabama at Birmingham |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this project is to develop novel approaches to promote health and longevity
while enhancing quality of life among persons with Sickle cell disease (SCD). Therefore,
investigators are aiming to adapt an evidence-based exercise intervention for adults with SCD
informed by culturally- relevant and biologic factors.
Description:
Sickle cell disease (SCD) is a major public health concern as it is the most common inherited
blood disorder in the US, affecting predominantly African Americans.1 SCD causes intermittent
painful vaso-occlusion events, which lead to multi-organ damage, significant morbidity and
early mortality.2 As a result, individuals with SCD often report poor quality of life, high
rates of work absenteeism, and increased healthcare utilization with estimated annual US
healthcare costs of 786 million.3-5 Historically, individuals with SCD did not live beyond 18
years of age, but patients are now living into the fifth decade of life due to advancements
in care.6 Cardiopulmonary disease (CVD) has replaced acute SCD-related complications as the
leading cause of death for adults with SCD.7 Specifically, SCD increases the risk for
pulmonary hypertension and congestive heart failure, which in turns causes mortality.8
Currently, there are knowledge gaps related to prevention of cardiopulmonary complications in
SCD. There are no validated therapies or strategies to modify cardiopulmonary disease for
persons with SCD (compared to other conditions) resulting in a disparity in care. Exercise is
associated with improved quality of life, reduced morbidity, and decreased mortality in
patients with advanced CVD, but regular exercise has yet to be studied in this context in
SCD.9,10 For this reason, there is a critical need to evaluate the impact of exercise to
address CVD risk and to promote longevity in SCD.
Previously, providers discouraged exercise for patients with advanced CVD.11 However, recent
data suggest exercise is not associated with increased risk in this population.12 In non-SCD,
advanced CVD, exercise training in cardiac rehabilitation is now considered an adjunctive
tool to decrease chronic inflammation, improve CVD outcomes, and decrease mortality.10
Similarly, moderate-intensity exercise regimens can be completed in SCD without adverse
complications.13 Mirroring the success of exercise therapy in CVD, there is potential for
efficacy as a therapeutic tool in SCD to decrease inflammation, aid vascular endothelium
remodeling, and improve endorgan dysfunction.14 Sterile inflammation secondary to chronic
hemolysis is a well-characterized pathogenetic mechanism that occurs in the development of
SCD cardiopulmonary disease.15 Regular exercise could modify CV disease progression in SCD by
targeting inflammation that leads to microvascular damage.
In preparation for this project, we collected preliminary quantitative data in 69 adults with
SCD; two-thirds of adults report physical inactivity, poor fitness, and exercise capacity -
deficits that lead to poor CV outcomes and early mortality.16,17 We also found that adults
with SCD have positive attitudes towards exercise and prefer individualized home-based
programs but indicate an overall lack of guidance to exercise. To date, investigating the
effect of exercise on sterile inflammation and adapting a lifestyle intervention to SCD - an
understudied and minority population - has not been addressed extensively. Therefore, there
is a need to develop exercise program for adults with SCD that integrates patient
perspectives, is safe, and could modify CV outcomes in SCD. Furthermore, home-based
interventions are more accessible, preferred by adults with SCD, and important to widely
implementing exercise interventions.18 Our objective is to pilot a home-based exercise
intervention tailored for adults with SCD based on patients' preferences. We hypothesize that
a moderate-intensity homebased exercise regimen tailored to adults with SCD is feasible and
acceptable. The overall long-term objective is to develop a safe exercise intervention to
promote sustainable physical activity that could decrease CV risk in SCD.