Benefits of Exercise Program in Pediatric HSCT
Condition: Exercise; Transplantation
Study type: Interventional

Summary: 
      Deconditioning is a common adverse effect of short and long-term immobilization. For months
      pediatric hematopoietic stem cell transplant patients can be quarantined while hospitalized,
      much of which time is spent immobilized putting these patients at a higher risk for loss of
      muscle strength, functionality, endurance, and quality of life. Phoenix Children's Hospital
      is conducting approximately forty (40) transplants per year. Adult studies have shown that
      exercise as an effective counter measure to deconditioning in stem cell transplant patients.
      However, there is a knowledge gap in pediatric HSCT. Thus this study is being conducted to
      determine if there is a correlation between intra-hospital exercise and improved
      functionality, mobility, strength, and quality of life. To achieve these aims investigators
      will perform a randomized control study. The investigators will aim to recruit 40 patients,
      20 in each arm, ages 4-21 at Phoenix Children's Hospital. Each participant will receive
      baseline measures by a physical therapist; for functionality using (WeeFIM), muscle strength
      using manual muscle testing (MMT), endurance using the 6-minute walk test, and quality of
      life using the NIH PROMIS measures. Measurements will be taken again at discharge and 6-weeks
      post-discharge. During hospital admittance the intervention group will perform exercise
      routines 3 times weekly while the control group will be treated per standard of care with no
      exercise intervention. Patients recruited must be receiving first HSCT. A full explanation of
      the study and possible benefits will be given to the patients and their families upon
      consent. Primary outcomes will look at endurance, functionality and muscle strength.
      Secondary outcomes will include QoL and amount of achievable "time out of bed".
    

Detailed description: 
      Despite growing numbers of publications describing the effects of these exercise modalities
      in adult HSCT patients, only limited attention has been paid to this effective supportive
      therapy in children. Only five publications describe the effectiveness of exercise training
      in pediatric HSCT. San Juan et al. showed beneficial effects on functional performance,
      muscle strength, and Qol scores in a study of children (aged 8-16) undergoing a supervised
      exercise program that included resistance and aerobic exercises for 3 weeks after HSCT. In
      another study, the moderate intensity exercise program implemented to children undergoing
      allogeneic HSCT for 3 weeks during hospitalization showed positive effects on body mass and
      body mass index (BMI), and no negative effect on immune cell recovery. It was found that a
      structured physical activity program has positive effects on Qol and fatigue scores in
      children undergoing peripheral blood stem cell transplantation. Yildez et al. showed
      improvement in areas such as functional performance, muscle strength, functional mobility.
      Marchese et al. showed an improvement in knee extension strength and ankle dorsiflexion range
      of motion.This study will implement an exercise program that is personalized to hematopoietic
      stem cell transplant recipients designed to prevent a decline in function/independence.
      Investigators will accomplish this by conducting a randomized controlled trial (RCT) that
      will examine the effect of an 8-12 week personalized exercise program compared to standard
      care following hematopoietic stem cell transplantation. Data from this study should increase
      understanding of the effect of exercise in this population on QoL, functional ability,
      endurance, muscle strength, and fatigue.
    

Intervention name(s): Exercise program
Intervention type(s): Other
Intervention description(s): Depending on the age, there will be two components of the exercise program completed by the patients. The first component will be strengthening exercises. The second component will be endurance activities. This will be administered by the physical therapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care