Fitness in Allogeneic Stem Cell Transplantation
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional

Summary: 
      Purpose: The primary hypothesis of this study is that the combination of interval exercise
      training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week
      intervention that will improve cardiorespiratory fitness in patients preparing to undergo
      allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but
      in respect to this study, MA refers to the use of wearable accelerometry paired with regular
      intervals of physical activity coaching from members of the study staff during the IET
      training. The study will also look at several secondary endpoints including the association
      of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor
      suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and
      quality of life before and after transplant.

      Participants: 60 patients will be randomized into two groups, 30 in the intervention group
      consisting of both IET and MA, and 30 in the control group applying usual care and use of
      wearable accelerometry without motivational physical activity coaching.

      Procedures (methods): Results of this study will inform a randomized, multi-site study of a
      pre-transplant exercise intervention.
    

Detailed description: 
      The investigator team for the current protocol has recently completed a single-arm pilot
      protocol (LCCC 1311) of a 6-week home-based unsupervised IET program (goal of three IET
      sessions per week, 65%-95% Max Heart Rate [MHR]) in patients planning to undergo alloHCT. In
      our study, participants preparing to undergo alloHCT experienced an average 3.8ml/kg*min
      improvement in peak volume of oxygen consumed (VO2peak) from pre to post-intervention.
      Patients in LCCC 1311 wore FitBit accelerometers throughout the study period.

      The primary purpose of the current randomized controlled trial is to determine, in patients
      preparing to undergo alloHCT, whether an intervention comprised of interval exercise training
      and motivational accelerometry (IET/MA) will improve cardiorespiratory fitness more than the
      control group who receives usual care and an accelerometer without motivational physical
      activity coaching. The study will also look at several secondary endpoints including the
      association of the intervention with changes in p16INK4a, and the association of the
      intervention with changes in symptoms and quality of life before and after transplant.

      This randomized controlled trial will include 60 patients preparing to undergo alloHCT (30 in
      the intervention group, 30 in the control group). We plan to analyze the effect of IET/MA on
      VO2peak. Subjects will be recruited after their transplant teams have determined that they
      will undergo alloHCT within the subsequent 5-12 weeks. Following recruitment, patients will
      undergo baseline fitness assessments consisting of cardiorespiratory exercise testing using
      indirect calorimetry on a cycle ergometry (for the assessment of VO2peak), 6 minute walk
      distance testing, and baseline physical activity, symptom and quality of life questionnaires.
      Participants randomized to the IET/MA group will then receive an individualized IET/MA
      prescription for a duration of at least 5 weeks, up until the time of admission for alloHCT
      or 12 weeks from the initiation of IET/MA, whichever occurs first. The mode of exercise can
      be walking, jogging, running, cycling, elliptical, stair climbing, or a combination of these,
      and will be performed unsupervised at home. For the first week, participants will be asked to
      engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and
      beyond, participants will undergo 3-4 sessions of IET, consisting of a 5 minute warm-up and
      five 2-minute intervals, with the goal of reaching 80% MHR, separated by 3 minutes of
      recovery/light activity in between each interval. Each exercise session is a total of 30
      minutes. Fitness assessments will be completed at the end of the intervention period, at the
      time of admission for alloHCT. Based on the improvement in VO2peak seen in the pre-alloHCT
      patient population in LCCC 1311, the current study is powered to detect a 3.8ml/kg*min
      VO2peak improvement in the intervention group relative to the control group.

      All participants in both groups will be provided with a FitBit Surge accelerometer.
      Participants in the intervention group will also receive weekly motivation from a study team
      member to achieve a 10% week over week improvement in average steps/day. Participants in the
      control group will not receive this physical activity coaching. Participants will continue to
      wear the accelerometers after the intervention and until 1 year following alloHCT.
      Participants in both groups will have blood drawn for p16INK4a levels before and after the
      IET intervention. Participants in both groups will also complete symptom and quality of life
      questionnaires before the intervention and periodically throughout the year following alloHCT
      (please see study plan and time and events tables).
    

Intervention name(s): Interval Exercise Training/Motivational Accelerometry
Intervention type(s): Behavioral
Intervention description(s): During the 5-12 weeks before allogeneic stem cell transplant, the patient will participate in an at home, interval exercise training (IET) program, as well as wear a physical activity tracker, the FitBit Surge, combined with a weekly motivational call, termed Motivational Accelerometry (MA). The combined intervention is referred to as (IET/MA). The first week of the IET program consists of the participants being asked to engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and beyond, patients be asked to undergo 3-4 sessions of IET, consisting of a 5 minute warm-up and five 2-minute intervals, with the goal of reaching 80% MHR, separated by 3 minutes of recovery/light activity in between each interval. Each exercise session is a total of 30 minutes. In addition, each week prior to transplant, the patient will receive a weekly check-in/motivational call from the study staff in order to track progress and motivate the patient to continue participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment