Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Feasibility, as measured by number of participants completing at least 50% of the exercise sessions
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
- •Understand and speak fluent English.
排除标准
- •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
- •Have severe avascular necrosis requiring an assist device
- •Unstable cardiac disease.
研究组 & 干预措施
Exercise
Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual
干预措施: Gerofit Exercise Program (Behavioral)
结局指标
主要结局
Feasibility, as measured by number of participants completing at least 50% of the exercise sessions
时间窗: 12 weeks
Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions
时间窗: 12 weeks
次要结局
- Safety, as measured by number of participants with moderate or severe adverse events(12 weeks)
- Acceptability, as measured by acceptability survey(12 weeks)
- Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events(12 weeks)
- Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable(12 weeks)