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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772391
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Healthcare System

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Sickle Cell Disease Exercise Other: Exercise Sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fitness Intervention Trial in Adults With Sickle Cell Disease (SCD Fit): A Feasibility Study
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : September 1, 2022
Actual Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Exercise Treatment Group
Exercise Sessions
Other: Exercise Sessions
Participant will complete up to 8 exercise sessions




Primary Outcome Measures :
  1. Feasibility will be measured [ Time Frame: One year ]
    Outcome will be to collect preliminary data on feasibility of the exercise intervention using rates of recruitment and retention

  2. Acceptability will be measured [ Time Frame: One year ]
    Outcome will be to collect preliminary data on acceptability of the exercise intervention using attendance, engagement, and qualitative feedback.

  3. Tolerability will be measured [ Time Frame: One year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772391


Locations
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United States, Florida
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
Memorial Healthcare System
Investigators
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Principal Investigator: Foluso Ogunsile, MD Memorial Healthcare System
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Responsible Party: Memorial Healthcare System
ClinicalTrials.gov Identifier: NCT04772391    
Other Study ID Numbers: IRB-300006888
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn