NCT05228756

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable cardiovascular-diseases

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

December 9, 2021

Last Update Submit

October 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Acceptability will be measured

    One year

Other Outcomes (1)

  • Tolerability will be measured

    One year

Study Arms (1)

Resistance Band exercise for Sickle Cell Disease

OTHER

Participants will complete 16 exercise session at home wearing an accelerometer

Other: Accelerometer

Interventions

Participants will complete 16 exercise sessions at home wearing an accelerometer

Resistance Band exercise for Sickle Cell Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants will include ambulatory adult patients of all SCD genotypes who are in care at UAB's sickle cell center and provide consent to participate in the study.
  • Eligible participants include adults with SCD of any genotype older than 18 yrs. of age followed by the UAB sickle cell center.
  • Participants must be in steady-state disease defined as not having a vaso-occlusive crisis or SCD-related hospitalization within four weeks of enrollment.

You may not qualify if:

  • Participants will be excluded if they have severe avascular necrosis of the hip, are pregnant, or have absolute contraindications to exercise according to the American Heart Association (AHA) and American College of Sports Medicine guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesAnemia, Sickle CellMotor Activity

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Foluso Ogunsile, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2021

First Posted

February 8, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10