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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Exercise; Sickle Cell Disease
• Intervention / Treatment: Other: Exercise Treatment Group

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Treatment Group	Other: Exercise Treatment Group; be specific

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One year

Collaborators and Investigators

• Sponsor: Memorial Healthcare System
• Investigators: Principal Investigator: Foluso J Ogunsile, MD, Memorial Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Cardiovascular Diseases; Anemia, Sickle Cell
• Other Study ID Numbers: SCDFit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No