NCT04181944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

June 14, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

November 20, 2019

Last Update Submit

December 6, 2022

Conditions

Cardiovascular DiseasesSickle Cell DiseaseExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Exercise Treatment Group

EXPERIMENTAL
Other: Exercise Treatment Group

Interventions

Exercise Treatment GroupOTHER

be specific

Exercise Treatment Group

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

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 J 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

November 20, 2019

First Posted

December 2, 2019

Study Start

June 14, 2020

Primary Completion

January 1, 2022

Study Completion

October 1, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

To be determined

Locations

US(1)