TY - JOUR
T1 - Progenitor cell release plus exercise to improve functional performance in peripheral artery disease
T2 - The PROPEL Study
AU - Domanchuk, Kathryn
AU - Ferrucci, Luigi
AU - Guralnik, Jack M.
AU - Criqui, Michael H.
AU - Tian, Lu
AU - Liu, Kiang
AU - Losordo, Douglas
AU - Stein, James
AU - Green, David
AU - Kibbe, Melina
AU - Zhao, Lihui
AU - Annex, Brian
AU - Perlman, Harris
AU - Lloyd-Jones, Donald
AU - Pearce, William
AU - Taylor, Doris
AU - McDermott, Mary M.
N1 - Funding Information:
This study is supported by the National Heart, Lung, and Blood Institute (grant number R01HL107510 ).
PY - 2013/11
Y1 - 2013/11
N2 - Functional impairment, functional decline, and mobility loss are major public health problems in people with lower extremity peripheral artery disease (PAD). Few medical therapies significantly improve walking performance in PAD. We describe methods for the PROgenitor cell release Plus Exercise to improve functionaL performance in PAD (PROPEL) Study, a randomized controlled clinical trial designed to determine whether granulocyte-macrophage colony stimulating factor (GM-CSF) combined with supervised treadmill walking exercise improves six-minute walk distance more than GM-CSF alone, more than supervised treadmill exercise alone, and more than placebo plus attention control in participants with PAD, respectively. PROPEL Study participants are randomized to one of four arms in a 2 by 2 factorial design. The four study arms are GM-CSF plus supervised treadmill exercise, GM-CSF plus attention control, placebo plus supervised exercise therapy, or placebo plus attention control. The primary outcome is change in six-minute walk distance at 12-week follow-up. Secondary outcomes include change in brachial artery flow-mediated dilation (FMD), change in maximal treadmill walking time, and change in circulating CD34. + cells at 12-week follow-up. Outcomes are also measured at six-week and six-month follow-up. Results of the PROPEL Study will have important implications for understanding mechanisms of improving walking performance and preventing mobility loss in the large and growing number of men and women with PAD.
AB - Functional impairment, functional decline, and mobility loss are major public health problems in people with lower extremity peripheral artery disease (PAD). Few medical therapies significantly improve walking performance in PAD. We describe methods for the PROgenitor cell release Plus Exercise to improve functionaL performance in PAD (PROPEL) Study, a randomized controlled clinical trial designed to determine whether granulocyte-macrophage colony stimulating factor (GM-CSF) combined with supervised treadmill walking exercise improves six-minute walk distance more than GM-CSF alone, more than supervised treadmill exercise alone, and more than placebo plus attention control in participants with PAD, respectively. PROPEL Study participants are randomized to one of four arms in a 2 by 2 factorial design. The four study arms are GM-CSF plus supervised treadmill exercise, GM-CSF plus attention control, placebo plus supervised exercise therapy, or placebo plus attention control. The primary outcome is change in six-minute walk distance at 12-week follow-up. Secondary outcomes include change in brachial artery flow-mediated dilation (FMD), change in maximal treadmill walking time, and change in circulating CD34. + cells at 12-week follow-up. Outcomes are also measured at six-week and six-month follow-up. Results of the PROPEL Study will have important implications for understanding mechanisms of improving walking performance and preventing mobility loss in the large and growing number of men and women with PAD.
KW - GM-CSF
KW - Intermittent claudication
KW - Peripheral vascular disease
KW - Physical functioning
KW - Stem cells
UR - http://www.scopus.com/inward/record.url?scp=84885936001&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84885936001&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2013.09.011
DO - 10.1016/j.cct.2013.09.011
M3 - Article
C2 - 24080099
AN - SCOPUS:84885936001
SN - 1551-7144
VL - 36
SP - 502
EP - 509
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -