Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Completion rate
研究概览
简要总结
This pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days post-HCT.
SECONDARY OBJECTIVES:
I. Examine the change from baseline of a RT intervention on muscle strength and body composition at day +200 and day +365.
II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 80 days but less than <120 days post-autologous or allogeneic HCT for a malignancy.
- •Platelet transfusion independent.
- •Fully mobile on an independent basis.
- •For patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =< 1.0 mg/kg/day and they must be on a tapering schedule.
- •English speaking.
排除标准
- •Individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen.
- •Women who are pregnant will be excluded.
结局指标
主要结局
Completion rate
时间窗: At day +200 post hematopoietic cell transplant (HCT)
Percentage of enrolled participants completing the full intervention
Enrollment rate
时间窗: 200 Days
Percentage of eligible, approached patients enrolling in program
Adherence rate
时间窗: At day +200 post hematopoietic cell transplant (HCT)
Percentage of participants completing weekly follow-up phone calls
次要结局
- Change in anthropometrics (BMI)(Baseline to day +365 post HCT)
- Heart rate(Baseline to day +365 post HCT)
- Change in muscular strength(Baseline to day +365 post HCT)
- Blood pressure(Baseline to day +365 post HCT)
- Change in quality of life (QOL)(Baseline to day +365 post HCT)
- Change in body composition(Baseline to day +365 post HCT)
- Incidence of adverse events(Up to day +200 post HCT)
- Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile)(Baseline to day +365 post HCT)
- Change in physical activity(Baseline to day +365 post HCT)