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Trial record 1 of 2 for:    15076800 [PUBMED-IDS]
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Fitness in Allogeneic Stem Cell Transplantation (FAST)

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ClinicalTrials.gov Identifier: NCT02564458
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William A. Wood, MD, UNC Lineberger Comprehensive Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Behavioral: Interval Exercise Training/Motivational Accelerometry Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fitness in Allogeneic Stem Cell Transplantation
Study Start Date : September 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interval Exercise Training/Motivational Accelerometry (IET/MA)
All patients on the experimental arm receive the intervention of 5-12 weeks of pre-transplant IET, motivational accelerometry via the FitBit Surge, pre- and post-fitness assessments, and periodic quality of life and symptom surveys.
Behavioral: Interval Exercise Training/Motivational Accelerometry
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.

No Intervention: Normal Standard of Care (control)
All patients on the control arm participate in the pre- and post-fitness assessment, are given the FitBit Surge without the motivational component, and are also given periodic quality of life and symptom surveys.



Primary Outcome Measures :
  1. Compare changes in VO2peak after a 5-12 week period of time prior to alloHCT in patients undergoing interval exercise training (IET) and motivational accelerometry (MA) vs patients receiving usual care (controls). [ Time Frame: 5-12 weeks ]
    Patients will undergo a baseline fitness assessment consisting of cardiorespiratory exercise testing using indirect calorimetry on a cycle ergometer (for the assessment of VO2peak).


Secondary Outcome Measures :
  1. Compare changes in 6 minute walk distance (6MWD) after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls. [ Time Frame: 5-12 weeks ]
  2. Compare changes in peripheral blood p16INK4a after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls. [ Time Frame: 5-12 weeks ]

Other Outcome Measures:
  1. Compare average steps per day during a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs. controls [ Time Frame: 5-12 weeks ]
  2. Compare post-alloHCT average steps per day in patients who received pre-alloHCT IET/MA vs controls. [ Time Frame: Post-alloHCT refers to Day0 (transplant day) through Day+365 ]
  3. Compare post-alloHCT symptom burden and quality of life in patients who received pre-alloHCT IET/MA vs controls. [ Time Frame: Post-alloHCT refers to Day0 (transplant day) through Day+365 ]
  4. Compare post-alloHCT days alive and out of the hospital within the first 100 days post-transplant in patients who received pre-alloHCT IET/MA vs controls. [ Time Frame: Post-alloHCT refers to the initial discharge day after allo-HCT through the first 100 days out of the hospital and/or alive, whichever is the shorter duration. ]
  5. Compare post-alloHCT survival in patients who received pre-alloHCT IET/MA vs controls. [ Time Frame: Post-alloHCT refers to Day0 (transplant day) through Day+365 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years of age, inclusive
  • Verification of a functioning email address and access to electronic device(s) with the ability to charge and sync the FitBit Surge
  • Planned allogeneic stem cell transplant with schedule that accommodates at least a 5 week exercise intervention, but not greater than 12 weeks
  • Ability to understand and communicate in English
  • Ability to understand and comply with study procedures for the entire length of the study
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
  • Co-morbid illness that would contraindicate maximal effort exercise testing or participation in regular exercise programming as determined by the treating physician or exercise physiologist
  • Concurrent radiation, chemotherapeutic, or investigational therapy other than transplant related therapy
  • Concurrent enrollment in LCCC 1404

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564458


Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: William A Wood, MD, MPH UNC Lineberger Comprehensive Cancer Center

Additional Information:
Publications:

Responsible Party: William A. Wood, MD, Dr. William A. Wood, MD, MPH, UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02564458     History of Changes
Other Study ID Numbers: 15-1705
1R21CA192127-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No