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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
Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SickleFit arm | Experimental | Participants in SickleFit arm will complete the Sickle Cell Disease Functional Assessment before and after 12 weeks of SickleFit exeercise+Nutrition intervention. |
|
| Control Arm | No Intervention | Participants in the control arm will be on a wait list for SickleFit and will continue to receive usual care during that 12-week period. They will complete the Sickle Cell Disease Functional Assessment at baseline and after 12 weeks on the wait list. After their post-assessment, they will have the option to complete 12 weeks of SickleFit exercise+Nutrition intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SickleFit Exercise plus Nutrition | Behavioral | SickleFit personalized exercise plus dietitian-facilitated nutrition intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Randomization | Feasibility of randomization (proportion of participants randomized out of those approached) | From enrollment to the last paticipants randomized over a 2 year period |
| Safety/Adverse Events | number of life-threatening adverse events | adverse events will be measured for both arms up to 6 months |
| Acceptability | Proportion of participants reporting satisfaction with the program | From enrollment to after completion of the SickleFit Program over 6 months since we will also measure acceptability for control group |
| Retention in the program | retention (proportion of the SickleFit and control groups completing follow up assessment) | From the baseline Sickle Cell Disease Functional Assessment to the post-SCD-FA. Over a 30 week period since post assessments will be completed within 3 months of completion of the SickleFit program or control period. |
| Adherence | Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm | From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance on the Sickle Cell Disease Functional Assessment (SCD-FA) | Change in physical performance and patient-reported outcomes on the Sickle Cell Disease Functional Assessment (SCD-FA) | From baseline assessment to completion of the post-assessment within 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teagan Callaway | Contact | 919-684-0628 | SICKLEFIT@duke.edu | |
| Rania Mohamed | Contact | rania.mohamed@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charity I Oyedeji, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Charity I Oyedeji, Teagan Callaway, Rania Mohamed, Reena Ravi, Richard Faldowski, Corey Vessels, Miriam C Morey, John J Strouse; The Sicklefit Exercise Program for Older Adults with Sickle Cell Disease: Feasibility, Acceptability, and Safety. Blood 2024; 144 (Supplement 1): 604. doi: https://doi.org/10.1182/blood-2024-212100 |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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We will conduct a 12-week randomized control trial of a combined SickleFit exercise plus dietitian-led nutrition education intervention to be delivered virtual via Zoom in 40 adults (age ≥ 35) with sickle cell disease. There will be 20 participants in the SickleFit arm and 20 participants in the control arm. Randomization will be done 1:1.
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |