Fitness Trial in Adults With Sickle Cell Disease (SCD Fit): A Feasibility Study

Fitness Intervention Trial in Adults With Sickle Cell Disease (SCD Fit): A Feasibility Study

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 and pre-test the adapted exercise program in a small sample of adults with SCD.

Study Overview

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

Detailed Description

Sickle cell disease (SCD) is a major public health concern as it is the most common inherited blood disorder in the US, affecting over 100,000 persons.(1) This disease predominantly affects African Americans, occurring in 1 out 365 African American births. Sickle cell disease causes intermittent extremely painful vaso-occlusion events, which lead to multi-organ damage, significant morbidity and early mortality - and resulting in increased healthcare utilization with estimated annual United States healthcare costs of 786 million.(2,3) To date, there are very few strategies for reducing pain, preventing organ dysfunction, and improving quality of life for persons with SCD leading to a disproportionate disparity in care. For this reason, there is a critical need to develop novel approaches to promote health and longevity while enhancing quality of life among persons with SCD.

Exercise capacity and cardiorespiratory fitness are important predictors of cardiovascular outcomes and overall survival; however, adults with SCD have severely reduced levels of fitness, with less than 50% of expected compared to the general population. (4) Since cardiopulmonary disease accounts for 40% of the mortality in adults with SCD, enhancing physical activity with regular exercise is one potential method for improving survival, reducing poor Cardiovascular disease (CVD) outcomes, and improving quality of life for adults with SCD.(5,6) Evidence-based exercise interventions in rheumatoid arthritis, an inflammatory, chronic disease with similar sequelae to SCD, have shown that exercise interventions can increase quality of life, reduce pain, and improve CVD outcomes.(7-9) Currently, a paucity of research on the benefits of exercise for SCD exists and this is a critical barrier to overcome to both understand the role of physical fitness SCD and to develop evidence-based recommendations to guide exercise in SCD. Only one small study of an exercise intervention program in France has reported exercise to be safe, effective, and reverse SCD-related muscle vasculature damage but long term data in larger populations are needed.(10) Therefore, there is a need to conduct more studies in the United States and to develop an evidence-based exercise program for adults with SCD that integrates patient perspectives, can be broadly implemented among different settings, and is physically safe. To address this unmet need, the central hypothesis of this proposal is that an evidence-based exercise intervention informed by the needs and preferences of adults with SCD will be feasible, acceptable, and tolerable in a cohort of adults with SCD. Our long-term goal is to develop a safe and effective exercise intervention to promote sustainable physical activity in SCD and to guide exercise recommendations for SCD which currently do not exist. Therefore, investigators propose to adapt an evidence-based exercise intervention for adults with SCD informed by culturally- relevant and biologic factors and pre-test the adapted exercise program in a small sample of adults with SCD.

Outcomes: The primary outcome will be to collect preliminary data on feasibility, acceptability, and tolerability of the exercise intervention. Rates of recruitment and retention will be measured to assess feasibility. Acceptability will be measured through attendance, engagement, and qualitative feedback. Tolerability will be measured by the ability for participants to complete the exercise program without adverse events.

• Study Type: Interventional
• Enrollment (Actual): 10
• 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:

• Participant must have sickle cell disease of any genotype
• Participant must be 18 years of age
• Participant must be seen and followed by the UAB sickle cell center
• Participant must have reliable transportation to the UAB center of Exercise Medicine
• Participant must be in steady-state disease (No vaso-occlusive crisis or SCD-related hospitalization with 4 weeks of enrollment)

Exclusion Criteria:

• Participant has avascular necrosis
• Participant is pregnant
• Participant has absolute contraindications to exercise according to the American Heart Association and American College of Sports Medicine guidelines (42)

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
Other: Exercise Treatment Group; Exercise Sessions	Other: Exercise Sessions; Participant will complete up to 8 exercise sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility will be measured	Outcome will be to collect preliminary data on feasibility of the exercise intervention using rates of recruitment and retention	One year
Acceptability will be measured	Outcome will be to collect preliminary data on acceptability of the exercise intervention using attendance, engagement, and qualitative feedback.	One year
Tolerability will be measured	Outcome will be to collect preliminary data on tolerability of the exercise intervention using the ability for participants to complete the exercise program without adverse events.	One year

Collaborators and Investigators

• Sponsor: Memorial Healthcare System
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Foluso Ogunsile, MD, Memorial Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

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: IRB-300006888; 5R25HL106365-12 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No