Sickle Cell Disease
Conditions
Keywords
sickle cell anemia, older adults, exercise, geriatrics, functional impairment
Brief summary
The purpose of this study to assess the feasibility, acceptability, and safety of a personalized exercise training program adapted from Gerofit to improve physical health and quality of life for adults with SCD
Detailed description
The purpose of this study is to adapt and pilot the Gerofit personalized exercise intervention for older adults with sickle cell disease (age ≥ 40 years). The Sickle Cell Disease Functional Assessment (SCD-FA) will be performed at steady state at baseline and every 3 months to track progress. Endpoints include feasibility, acceptability, and safety. All participants will be interviewed to identify barriers and facilitators to exercise and how to better optimize the exercise intervention.
Interventions
BEHAVIORALGerofit Exercise Program
The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Sponsors
Duke University
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping * Understand and speak fluent English.
Exclusion criteria
* Diagnosed with moderate or severe cognitive impairment based on ICD-10 codes or report from their outpatient provider * Unable to self-consent * Wheelchair-bound * Successfully treated with hematopoietic stem cell transplantation for SCD * Have moderate to severe uncorrected visual or auditory impairment * Oxygen-dependent * Pregnant * Have severe avascular necrosis requiring an assist device * Unstable cardiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events | 12 weeks | Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session. |
| Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable | 12 weeks | Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharity I Oyedeji, MD
Duke University
Participant flow
Pre-assignment details
One participant was withdrawn by the PI due to weekly hospitalizations and never started the program. Two participants consented but never completed the safety orientation and never started the program. Both cited a busy schedule and inability to make the time commitment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 9.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed