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Randomized Controlled Trial
. 2013 Nov;36(2):502-9.
doi: 10.1016/j.cct.2013.09.011. Epub 2013 Sep 27.

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

Kathryn Domanchuk  1 , 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
Affiliations
Randomized Controlled Trial

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

Kathryn Domanchuk et al. Contemp Clin Trials. 2013 Nov.

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.

Trial registration: ClinicalTrials.gov NCT01408901.

Keywords: GM-CSF; Intermittent claudication; Peripheral vascular disease; Physical functioning; Stem cells.

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Figures

Figure 1
Figure 1
Theoretical model by which interventions improve outcomes in the PROPEL Study.
Figure 2
Figure 2
Overview of data collection and interventions for the PROPEL Study
See this image and copyright information in PMC

References

    1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics—2013 Update: A Report from the American Heart Association. Circulation. 2013;127:e6–e245. - PMC - PubMed
    1. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. Oct 3. 2001;286(13):1599–606. - PubMed
    1. McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. Jul 28. 2004;292(4):453–61. - PubMed
    1. McDermott MM, Greenland P, Liu K, Guralnik JM, Celic L, Criqui MH, Chan C, Martin GJ, Schneider J, Pearce WH, Taylor LM, Clark E. The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study. Ann Intern Med. 2002 Jun 18;136(12):873–83. - PubMed
    1. McDermott MM, Guralnik JM, Tian L, et al. Baseline functional performance predicts the rate of mobility loss in peripheral arterial disease. J Am Coll Cardiol. 2007;50:974–982. - PMC - PubMed

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