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

NCT04772391 | Completed

• 1 other identifier: IRB-300006888
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Sickle Cell Disease; Exercise

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Exercise Treatment Group

OTHER

Exercise Sessions

Other: Exercise Sessions

Interventions

Exercise Sessions OTHER

Participant will complete up to 8 exercise sessions

Exercise Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Healthcare System: lead

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Anemia, Sickle Cell; Motor Activity

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Foluso Ogunsile, MD

  Memorial Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)