Evaluation of Cardiorespiratory Performance After Interval Exercise Training Prior to Hematopoietic Cell Transplantation
Condition: Stem Cell Transplantation, Hematopoietic
Study type: Interventional

Summary: 
      The primary objective of this study is to demonstrate the efficacy of a pre-transplant,
      interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak)
      scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is
      feasible in this population. Secondary objectives include documenting the safety of IET in
      this population, evaluating the correlation of VO2peak with other methods of measuring
      pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre
      and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a
      health care professional.

      Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full
      intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise
      intervention by their treating physician. The investigators will enroll no more than 50
      patients onto this trial. Results of this study will inform a randomized, multi-site study of
      a pre-transplant exercise intervention.
    

Detailed description: 
      The primary purpose of the study is to determine the ability of a pre-transplant exercise
      intervention to improve cardiorespiratory performance (measured by VO2peak). If the safety of
      this approach is documented, and its efficacy demonstrated, a foundation will be laid for a
      larger, randomized, multi-center study to formally determine the benefit of the
      pre-transplant exercise intervention.

      We plan to analyze the effect of IET on VO2peak in the auto and allo groups separately given
      their different course of treatment and outcomes. Study subjects will be recruited after they
      and their transplant teams have decided that they will undergo HCT. Following recruitment,
      patients will undergo baseline fitness assessments and then receive an individualized IET
      prescription for a duration of 6 weeks prior to stem cell mobilization (auto) or prior to
      hospitalization for conditioning (allo). For the first two weeks, subjects will undergo three
      times weekly 3 minute interval training during walking at 60-70% MHR. This will be followed
      by three times weekly aerobic interval training for 5 three-minute bouts at 65-85% maximum
      heart rate per session for 4 weeks.

      All patients will also be provided with a FitBit accelerometer. Prior to transplant, patients
      will undergo follow-up fitness assessments. All patients will undergo activity tracking by
      accelerometry (FitBit) and admission/weekly symptom/HRQOL tracking by electronic survey
      throughout the post-transplant hospitalization. Also during hospitalization, all patients
      will perform weekly clinician supervised 6MWD testing while inpatient. One of the weekly
      tests during hospitalization will include patient self-administered (clinician observed)
      6MWD, along with the clinician supervised 6MWD. Unsupervised patient performed 6MWD will be
      considered feasible if all patients who perform 6MWD can do so safely, and if for 80% of
      patients, the patient-performed 6MWD values are within 10% of the corresponding clinician
      supervised 6MWD results. If feasibility is met, we will ask patients to perform the 6MWD
      weekly for 4 weeks post discharge and record their distance.
    

Intervention name(s): Interval Exercise Training (IET)
Intervention type(s): Behavioral
Intervention description(s): This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.
Other intervention name(s): Aerobic Training; Aerobic Exercise; Endurance Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment