What side effects are associated with this type of intervention?

Hydroxyurea, a common treatment for SCD, can cause side effects such as bone marrow suppression, leading to decreased white blood cells and platelets, gastrointestinal disturbances, and potential long-term risks like secondary leukemia. Chronic transfusions can lead to iron overload, alloimmunization, and transfusion reactions. Hematopoietic stem cell transplantation, while potentially curative, carries risks of graft-versus-host disease, infections, and organ damage. Physical activity programs, like the Personalized Exercise Training Program, generally have minimal side effects but may include muscle soreness, fatigue, and the risk of injury if not properly supervised.

What prior FDA approvals exist?

Hydroxyurea is a key FDA-approved medication for Sickle Cell Disease, known for reducing vaso-occlusive pain and other complications. It improves overall quality of life and daily functioning, which can indirectly support physical health and well-being. While the context does not mention FDA-approved drugs specifically designed to enhance cardiovascular health and muscle strength in SCD patients, the Personalized Exercise Training Program being studied aims to fill this gap by focusing on tailored physical activity to improve these aspects.

What other types of research exist?

Promising novel alternatives to personalized exercise training programs for Sickle Cell Disease patients in 2024 include: 1) Hydroxyurea, which remains the first-line therapy for reducing vaso-occlusive pain and other complications, with well-established efficacy and safety profiles. 2) Chronic transfusions, which can help prevent complications by maintaining lower levels of sickled cells. 3) Hematopoietic cell transplantation, which offers a potential cure by replacing the defective blood-forming cells with healthy ones. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan for individual needs.

← Back to Search

Gerofit Exercise for Sickle Cell Disease (SICKLE-FIT Trial)

N/A

Recruiting

Led By Charity I Oyedeji, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping

Be older than 18 years old

Must not have

Have moderate to severe uncorrected visual or auditory impairment

Oxygen-dependent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a personalized exercise program for adults aged 40 and older with sickle cell disease. The goal is to see if this exercise plan can improve their physical health and quality of life. Participants will be monitored regularly to track their progress and provide feedback on the program. Exercise programs have been studied as a potential therapeutic strategy for patients with sickle cell disease, showing benefits in functional capacity and cardiovascular health.

Who is the study for?

This trial is for adults with Sickle Cell Disease (SCD) who can speak English fluently. Participants must have a confirmed diagnosis of any genotype of SCD. It's not suitable for those with unstable heart disease, severe cognitive issues, wheelchair users, oxygen-dependent individuals, or those who've had successful stem cell transplants for SCD.

What is being tested?

The study is testing the Gerofit Exercise Program to see if it's safe and effective in improving physical health and quality of life in adults with SCD. The program will be personalized to each participant's abilities and needs.

What are the potential side effects?

Since this is an exercise-based intervention, potential side effects may include muscle soreness, fatigue, joint pain or discomfort during or after exercise sessions. However, the program aims to minimize risks by personalizing activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sickle cell disease through a specific blood test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have significant hearing or vision loss that hasn't been corrected.

Select...

I need oxygen support to breathe.

Select...

I do not have unstable heart conditions.

Select...

I have had a successful stem cell transplant for sickle cell disease.

Select...

I use a wheelchair for mobility.

Select...

I have been diagnosed with moderate or severe memory or thinking problems.

Select...

I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Acceptability, as measured by acceptability survey

Safety, as measured by number of participants with moderate or severe adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ExerciseExperimental Treatment1 Intervention

Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sickle Cell Disease (SCD) include hydroxyurea, chronic transfusions, and hematopoietic stem cell transplantation. Hydroxyurea works by increasing fetal hemoglobin (Hb F) levels, which reduces the sickling of red blood cells and decreases vaso-occlusive events. Chronic transfusions lower the proportion of sickle hemoglobin (Hb S) in the blood, preventing severe complications such as stroke. Hematopoietic stem cell transplantation can potentially cure SCD by replacing defective blood-forming cells with healthy ones. Additionally, personalized exercise programs can significantly improve cardiovascular health, muscle strength, and overall well-being, helping patients manage the chronic symptoms and improve their quality of life.

The risk of sudden death in sickle cell trait: noninvasive assessmanet of cardiac response to exercise.Ischaemia-induced muscle metabolic abnormalities are poorly alleviated by endurance training in a mouse model of sickle cell disease.Exercise capacity and clinical outcomes in adults followed in the Cooperative Study of Sickle Cell Disease (CSSCD).