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

Primary Purpose

Cardiovascular Diseases, Sickle Cell Disease, Exercise

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Treatment Group
Sponsored by
Memorial Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Specific exercise regimen for those living with sickle cell disease
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

Secondary Outcome Measures

Full Information

First Posted
November 20, 2019
Last Updated
December 6, 2022
Sponsor
Memorial Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04181944
Brief Title
Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA)
Acronym
SCA
Official Title
Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Sickle Cell Disease, Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Treatment Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise Treatment Group
Intervention Description
be specific
Primary Outcome Measure Information:
Title
Specific exercise regimen for those living with sickle cell disease
Description
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
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Foluso J Ogunsile, MD
Organizational Affiliation
Memorial Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined

Learn more about this trial

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

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