Progenitor cell release plus exercise to improve functional performance in peripheral artery disease: the PROPEL Study.
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.
Department of Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA.
Kathryn
K
Domanchuk
Luigi
L
Ferrucci
Jack M
JM
Guralnik
Michael H
MH
Criqui
Lu
L
Tian
Kiang
K
Liu
Douglas
D
Losordo
James
J
Stein
David
D
Green
Melina
M
Kibbe
Lihui
L
Zhao
Brian
B
Annex
Harris
H
Perlman
Donald
D
Lloyd-Jones
William
W
Pearce
Doris
D
Taylor
Mary M
MM
McDermott
D055109:Ankle Brachial Index; D003131:Combined Modality Therapy; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000188:drug therapy / Q000628:therapy*; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
D016178:Granulocyte-Macrophage Colony-Stimulating Factor
GM-CSF; Intermittent claudication; Peripheral vascular disease; Physical functioning; Stem cells