Hematopoietic Stem Cell TransplantationFASTNCT02564458
Fitness in Allogeneic Stem Cell Transplantation
A study testing Interval Exercise Training/Motivational Accelerometry in people with Hematopoietic Stem Cell Transplantation, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Interval Exercise Training/Motivational Accelerometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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).
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Interval Exercise Training/Motivational Accelerometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval Exercise Training/Motivational AccelerometryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interval Exercise Training/Motivational Accelerometry (IET/MA) | Experimental | 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. Receives: Behavioral: Interval Exercise Training/Motivational Accelerometry |
| Normal Standard of Care (control) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Patients will undergo a baseline fitness assessment consisting of cardiorespiratory exercise testing using indirect calorimetry on a cycle ergometer (for the assessment of VO2peak).
Measured: 5-12 weeks
Secondary outcomes (2)
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.
Measured: 5-12 weeks
Compare changes in peripheral blood p16INK4a after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls.
Measured: 5-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, William A. Wood, MD, UNC Lineberger Comprehensive Cancer Center
- Investigators
- William A Wood, MD, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564458
- Sponsor's protocol ID
- 15-1705
- Other IDs
- 1R21CA192127-01A1
- Acronym
- FAST
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bevans MF, Mitchell SA, Marden S. The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT). Support Care Cancer. 2008 Nov;16(11):1243-54. doi: 10.1007/s00520-008-0420-6. Epub 2008 Mar 6.
PubMed 18322708Bevans M. Health-related quality of life following allogeneic hematopoietic stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2010;2010:248-54. doi: 10.1182/asheducation-2010.1.248.
PubMed 21239801Khera N, Zeliadt SB, Lee SJ. Economics of hematopoietic cell transplantation. Blood. 2012 Aug 23;120(8):1545-51. doi: 10.1182/blood-2012-05-426783. Epub 2012 Jun 13.
PubMed 22700725Majhail NS, Rizzo JD, Hahn T, Lee SJ, McCarthy PL, Ammi M, Denzen E, Drexler R, Flesch S, James H, Omondi N, Pedersen TL, Murphy E, Pederson K. Pilot study of patient and caregiver out-of-pocket costs of allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2013 Jun;48(6):865-71. doi: 10.1038/bmt.2012.248. Epub 2012 Dec 10.
PubMed 23222378Wiskemann J, Dreger P, Schwerdtfeger R, Bondong A, Huber G, Kleindienst N, Ulrich CM, Bohus M. Effects of a partly self-administered exercise program before, during, and after allogeneic stem cell transplantation. Blood. 2011 Mar 3;117(9):2604-13. doi: 10.1182/blood-2010-09-306308. Epub 2010 Dec 29.
PubMed 21190995Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.
PubMed 18026154Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
PubMed 22900793Guiraud T, Labrunee M, Gaucher-Cazalis K, Despas F, Meyer P, Bosquet L, Gales C, Vaccaro A, Bousquet M, Galinier M, Senard JM, Pathak A. High-intensity interval exercise improves vagal tone and decreases arrhythmias in chronic heart failure. Med Sci Sports Exerc. 2013 Oct;45(10):1861-7. doi: 10.1249/MSS.0b013e3182967559.
PubMed 23591293Puhan MA, Busching G, Schunemann HJ, VanOort E, Zaugg C, Frey M. Interval versus continuous high-intensity exercise in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2006 Dec 5;145(11):816-25. doi: 10.7326/0003-4819-145-11-200612050-00006.
PubMed 17146066Nybo L, Sundstrup E, Jakobsen MD, Mohr M, Hornstrup T, Simonsen L, Bulow J, Randers MB, Nielsen JJ, Aagaard P, Krustrup P. High-intensity training versus traditional exercise interventions for promoting health. Med Sci Sports Exerc. 2010 Oct;42(10):1951-8. doi: 10.1249/MSS.0b013e3181d99203.
PubMed 20195181Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
PubMed 18029834Shephard RJ. Tests of maximum oxygen intake. A critical review. Sports Med. 1984 Mar-Apr;1(2):99-124. doi: 10.2165/00007256-198401020-00002.
PubMed 6385195Jones LW, Eves ND, Haykowsky M, Joy AA, Douglas PS. Cardiorespiratory exercise testing in clinical oncology research: systematic review and practice recommendations. Lancet Oncol. 2008 Aug;9(8):757-65. doi: 10.1016/S1470-2045(08)70195-5.
PubMed 18672211ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Liu Y, Sanoff HK, Cho H, Burd CE, Torrice C, Ibrahim JG, Thomas NE, Sharpless NE. Expression of p16(INK4a) in peripheral blood T-cells is a biomarker of human aging. Aging Cell. 2009 Aug;8(4):439-48. doi: 10.1111/j.1474-9726.2009.00489.x. Epub 2009 May 22.
PubMed 19485966
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness in Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02564458
- Acronym / sponsor ID
- FAST / 15-1705
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Sep 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval Exercise Training/Motivational Accelerometry (IET/MA) | Experimental | Behavioral: Interval Exercise Training/Motivational AccelerometryAll 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. |
| Normal Standard of Care (control) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval Exercise Training/Motivational AccelerometryDuring 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. | Behavioural | Interval Exercise Training/Motivational Accelerometry (IET/MA) |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 18322708Bevans MF, Mitchell SA, Marden S. The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT). Support Care Cancer. 2008 Nov;16(11):1243-54. doi: 10.1007/s00520-008-0420-6. Epub 2008 Mar 6.
- Background: PubMed 21239801Bevans M. Health-related quality of life following allogeneic hematopoietic stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2010;2010:248-54. doi: 10.1182/asheducation-2010.1.248.
- Background: PubMed 22700725Khera N, Zeliadt SB, Lee SJ. Economics of hematopoietic cell transplantation. Blood. 2012 Aug 23;120(8):1545-51. doi: 10.1182/blood-2012-05-426783. Epub 2012 Jun 13.
- Background: PubMed 23222378Majhail NS, Rizzo JD, Hahn T, Lee SJ, McCarthy PL, Ammi M, Denzen E, Drexler R, Flesch S, James H, Omondi N, Pedersen TL, Murphy E, Pederson K. Pilot study of patient and caregiver out-of-pocket costs of allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2013 Jun;48(6):865-71. doi: 10.1038/bmt.2012.248. Epub 2012 Dec 10.
- Background: PubMed 21190995Wiskemann J, Dreger P, Schwerdtfeger R, Bondong A, Huber G, Kleindienst N, Ulrich CM, Bohus M. Effects of a partly self-administered exercise program before, during, and after allogeneic stem cell transplantation. Blood. 2011 Mar 3;117(9):2604-13. doi: 10.1182/blood-2010-09-306308. Epub 2010 Dec 29.
- Background: PubMed 18026154Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.
- Background: PubMed 22900793Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
- Background: PubMed 23591293Guiraud T, Labrunee M, Gaucher-Cazalis K, Despas F, Meyer P, Bosquet L, Gales C, Vaccaro A, Bousquet M, Galinier M, Senard JM, Pathak A. High-intensity interval exercise improves vagal tone and decreases arrhythmias in chronic heart failure. Med Sci Sports Exerc. 2013 Oct;45(10):1861-7. doi: 10.1249/MSS.0b013e3182967559.
- Background: PubMed 17146066Puhan MA, Busching G, Schunemann HJ, VanOort E, Zaugg C, Frey M. Interval versus continuous high-intensity exercise in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2006 Dec 5;145(11):816-25. doi: 10.7326/0003-4819-145-11-200612050-00006.
- Background: PubMed 20195181Nybo L, Sundstrup E, Jakobsen MD, Mohr M, Hornstrup T, Simonsen L, Bulow J, Randers MB, Nielsen JJ, Aagaard P, Krustrup P. High-intensity training versus traditional exercise interventions for promoting health. Med Sci Sports Exerc. 2010 Oct;42(10):1951-8. doi: 10.1249/MSS.0b013e3181d99203.
- Background: PubMed 18029834Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
- Background: PubMed 6385195Shephard RJ. Tests of maximum oxygen intake. A critical review. Sports Med. 1984 Mar-Apr;1(2):99-124. doi: 10.2165/00007256-198401020-00002.
- Pasquini MC, Wang Z. Current use and outcome of hematopoietic stem cell transplantation: CIBMTR Summary Slides, 2011. Slides 3, 18, 21-40.Link provided by the sponsor.
- National Cancer Institute. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Link provided by the sponsor.
- National Institutes of Health. Patient Reported Outcomes Measurement Information System (PROMIS).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A Wood, MD, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Exercise Training/Motivational Accelerometry in people with Hematopoietic Stem Cell Transplantation, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564458, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.