Evaluation of Cardiorespiratory Performance After Interval Exercise Training Prior to Hematopoietic Cell Transplantation
Completed · Not applicable
Conditions studied: Stem Cell Transplantation, Hematopoietic
In brief
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.
Key facts
- Study ID
- NCT02577939
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 40
- Starts
- 2013-06-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2015-10-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Not currently participating in IET training
- Willing and able to provide signed, informed consent
- Planned autologous or allogeneic stem cell transplant with schedule that accommodates a 6 week exercise intervention
- Willing to participate in an IET program that will last 6 weeks.
- Subject must complete at least one interval exercise session during the 6 weeks in order to be eligible for analysis.
- Planning to undergo transplant but continuing to receive cycles of chemotherapy on a previously started regimen while awaiting transplant
You may not qualify if…
- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- Received erythropoiesis-stimulating proteins (ESPs) within 4 weeks prior to enrollment
Where it is running
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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