Progenitor cell release plus exercise to improve functional performance in peripheral artery disease: The PROPEL Study

Kathryn Domanchuk, Luigi Ferrucci, Jack M. Guralnik, Michael H. Criqui, Lu Tian, Kiang Liu, Douglas Losordo, James Stein, David Green, Melina Kibbe, Lihui Zhao, Brian Annex, Harris Perlman, Donald Lloyd-Jones, William Pearce, Doris Taylor, Mary M. McDermott

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)502-509
Number of pages8
JournalContemporary Clinical Trials
Volume36
Issue number2
DOIs
StatePublished - Nov 2013

Keywords

  • GM-CSF
  • Intermittent claudication
  • Peripheral vascular disease
  • Physical functioning
  • Stem cells

ASJC Scopus subject areas

  • Pharmacology (medical)

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    Domanchuk, K., Ferrucci, L., Guralnik, J. M., Criqui, M. H., Tian, L., Liu, K., Losordo, D., Stein, J., Green, D., Kibbe, M., Zhao, L., Annex, B., Perlman, H., Lloyd-Jones, D., Pearce, W., Taylor, D., & McDermott, M. M. (2013). Progenitor cell release plus exercise to improve functional performance in peripheral artery disease: The PROPEL Study. Contemporary Clinical Trials, 36(2), 502-509. https://doi.org/10.1016/j.cct.2013.09.011