Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Median number of exercise sessions delivered pre-HCT and post-HCT.
研究概览
简要总结
This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort A (Prehab)
- •Age 60 years or older.
- •Planned allogeneic HCT in the next 1-6 months.
- •Hematological malignancy as the indication for HCT.
- •Pre-frail or frail by Fried frailty phenotype.
- •Cohort B (Rehab)
- •Age 60 years or older.
- •Planned allogeneic HCT or HCT within the last 30 days.
- •Hematological malignancy as the indication for HCT.
排除标准
- •Cohorts A and B
- •1. Comorbid disability or illness that prevents safe exercise.
研究组 & 干预措施
Cohort A (Prehab)
Pre-frail and frail subjects will attend at least twice weekly exercise sessions with a physical therapist and be given an exercise program to complete at home prior to admission for HCT. Patients enrolled in this cohort can continue on to Cohort B.
干预措施: Exercise Program (Cohort A Prehab) (Behavioral)
Cohort B (Rehab)
All patients 60 years and older upon discharge from their initial hospital stay for HCT will attend at least weekly exercise sessions with a physical therapist and be given an exercise program to complete at home with sessions continued through Day +100 after HCT.
干预措施: Exercise Program (Cohort B Rehab) (Behavioral)
结局指标
主要结局
Median number of exercise sessions delivered pre-HCT and post-HCT.
时间窗: From 3 months prior to HCT to 100 days after HCT
Proportion of enrolled subjects who participate in the supervised exercise program
时间窗: From 3 months prior to HCT to 100 days after HCT
次要结局
- 1-year and 2-year PFS(From day 0 of HCT to 1-year and 2-years)
- Hospital LOS for HCT(From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months)
- Rate of readmission(From time of discharge from initial hospital stay up through 1-2 years after HCT)
- 6-month and 1-year overall mortality(From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS)
- 1-year and 2-year OS(From day 0 of HCT to 1-year and 2-years)