40 Participants NeededMy employer runs this trial

SickleFit Exercise and Nutrition for Sickle Cell Disease

TC
RM
Overseen ByRania Mohamed
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program that combines exercise and nutrition, specifically designed for adults with sickle cell disease. The goal is to determine if this program can improve health and daily functioning for individuals with this condition. Participants will either begin the program immediately or wait 12 weeks while continuing their usual care. The trial seeks adults diagnosed with sickle cell disease who can speak and understand English. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for those with sickle cell disease.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SickleFit exercise and nutrition intervention is safe for adults with sickle cell disease?

Research has shown that the SickleFit exercise and nutrition program is safe for adults with sickle cell disease. One study found that participants did not experience any major or life-threatening problems due to the program. The program proved to be feasible and acceptable, allowing people to complete it without serious issues. Another study noted that controlled exercise, as in SickleFit, is well-tolerated by individuals with sickle cell disease and can enhance their health. These findings suggest that the SickleFit program is generally safe and manageable for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the SickleFit Exercise and Nutrition protocol because it offers a non-drug approach to managing sickle cell disease, focusing on lifestyle modifications like exercise and diet. Unlike standard treatments that primarily involve medications like hydroxyurea or blood transfusions, SickleFit aims to enhance patients' quality of life through holistic health improvements. This approach could empower individuals with sickle cell disease to take an active role in their health management, potentially reducing complications and improving overall well-being.

What evidence suggests that the SickleFit Exercise plus Nutrition intervention could be effective for sickle cell disease?

Research has shown that exercise can be safe and beneficial for people with sickle cell disease (SCD). For instance, a study in France found that exercise improved blood flow to muscles in individuals with SCD. Another study demonstrated that the SickleFit exercise program was safe and well-received among older adults with SCD, with most participants rating their results as good or very good. Exercise has also been linked to a better quality of life and fewer health issues for those with SCD. In this trial, participants in the SickleFit arm will engage in a combined exercise and nutrition program, which previous findings suggest could offer real benefits for people living with this condition.25678

Who Is on the Research Team?

CI

Charity I Oyedeji, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 35 or older who have sickle cell disease and can understand English. People can't join if they've had a stem cell transplant or gene therapy, need oxygen, have severe heart problems, are pregnant, use a wheelchair, can't give consent themselves, or have major vision/hearing issues.

Inclusion Criteria

Understand and speak English by self-report
I have been diagnosed with sickle cell disease.
I am 35 years old or older.

Exclusion Criteria

I have been cured of sickle cell disease with stem cell transplant or gene therapy.
I need to use oxygen regularly.
Diagnosed with severe cognitive impairment based on ICD-10 codes or reported by their outpatient provider
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the SickleFit arm undergo a 12-week exercise and nutrition intervention

12 weeks
Regular sessions (frequency not specified)

Control Period

Participants in the control arm are on a wait list and receive usual care for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Optional SickleFit Extension

Control group participants have the option to complete 12 weeks of SickleFit exercise and nutrition intervention after the control period

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SickleFit Exercise plus Nutrition

Trial Overview

The study is testing whether a special exercise and nutrition program called SickleFit helps adults with sickle cell disease. Participants are randomly assigned to either receive this program or not.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SickleFit armExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

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

Only one small study of an exercise intervention program in France has reported exercise to be safe, effective, and reverse SCD-related muscle vasculature ...

Personalized Exercise Intervention for Older Adults with ...

Conclusion In cohort 1, we found that the SickleFit exercise program is feasible, acceptable, and safe for older adults with SCD. Participants ...

Gerofit Exercise Intervention for Older Adults with Sickle Cell ...

The Sickle-Fit virtual exercise study is important because older adults with SCD are at high risk of premature functional decline. Interventions ...

Effectiveness of a home-based therapeutic exercise program ...

To investigate the effectiveness of a home-based therapeutic exercise program on lower back pain and functionality of SCD patients.

SickleFit Exercise and Nutrition for Sickle Cell Disease

To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized control trial.

Personalized Exercise Intervention for Older Adults with ...

In cohort 1, we found that the SickleFit exercise program is feasible, acceptable, and safe for older adults with SCD. Participants demonstrated improvements in ...

The Sicklefit Exercise Program for Older Adults with Sickle ...

The safety goal was no major or life-threatening adverse events (AEs) related to the intervention. Participants completed acceptability surveys.

SickleFit Randomized Control Trial

To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized ...