Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline 6-minute walk test at 6 weeks discharge.
研究概览
简要总结
This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The physical therapist doing the evaluations, the data analyst, and primary investigator will all be masked.
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
- •Karnofsky (if ≥16 years) or Lansky (if <16 years) score >60 at enrollment and prior to each testing point
- •Parental/guardian permission (informed consent) and child assent prior to transplant.
排除标准
- •Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
- •Previous stem cell transplant in the last 6 months
- •Patients with grade 3 or greater sensory/motor neuropathy
研究组 & 干预措施
Exercise
This structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. In addition to standard of care, it consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization. This exercise program will be done three times a week for 30-45 mins supervised by the same physiotherapist throughout hospitalization and will be self-administered every weekend. A home exercise program printout with the appropriate resistance exercises will be provided to the family upon discharge, with instructions on how often to complete throughout the week. Discharged children will attend one supervised exercise session per week with the physiotherapist for six weeks. The family and patient will also be provided a weekly sheet to check off the days they completed strengthening and endurance exercises.
干预措施: Exercise regimen (Behavioral)
Standard of Care
The second arm of the study involves patients following standard of care during the HSCT period in the hospital with PT evaluation and management prescribed as needed by their transplant medical team including any additional PT interventions as a result of clinical indications. No additional intervention is incorporated in this group
结局指标
主要结局
Change from Baseline 6-minute walk test at 6 weeks discharge.
时间窗: Average of 100 days post-transplant
Test of Endurance (Pre-transplant, at discharge, and 6 weeks discharge.)
Change from Baseline Manual Muscle Testing at 6 weeks post discharge
时间窗: Average of 100 days post-transplant
Muscle strength
WeeFIM
时间窗: Average of 100 days post-transplant
Change from Baseline Functionality at 6 weeks post discharge.
次要结局
- PROMISE Measures(Average of 100 days post transplant)
- Time Out of Bed(through study completion, average of 1 year)