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Randomized Controlled Trial
. 2015 May 20;4(5):e001659.
doi: 10.1161/JAHA.114.001659.

Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial

Mary M McDermott  1 , Jack M Guralnik  2 , Michael H Criqui  3 , Luigi Ferrucci  4 , Kiang Liu  5 , Bonnie Spring  5 , Lu Tian  6 , Kathryn Domanchuk  7 , Melina Kibbe  8 , Lihui Zhao  5 , Donald Lloyd Jones  1 , Yihua Liao  5 , Ying Gao  5 , W Jack Rejeski  9
Affiliations
Randomized Controlled Trial

Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial

Mary M McDermott et al. J Am Heart Assoc. .

Abstract

Background: Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease (PAD). Among people with PAD, we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control.

Methods and results: One hundred ninety-four PAD participants were randomized. During months 1 to 6, the intervention group met weekly with other PAD participants and a facilitator. Group support and self-regulatory skills were used to help participants adhere to walking exercise. Ninety-percent of exercise was conducted at or near home. The control group attended weekly lectures. During months 6 to 12, each group received telephone contact only. Primary outcomes have been reported. Here we compare changes in exploratory outcomes of mobility loss (the inability to climb a flight of stairs or walk one-quarter mile without assistance), walking velocity, and the Short Physical Performance Battery. Compared to controls, fewer participants randomized to the intervention experienced mobility loss at 6-month follow-up: 6.3% versus 26.5%, P=0.002, odds ratio=0.19 (95% CI=0.06 to 0.58) and at 12-month follow-up: 5.2% versus 18.5%, P=0.029, odds ratio=0.24 (95% CI=0.06 to 0.97). The intervention improved fast-paced 4-m walking velocity at 6-month follow-up (P=0.005) and the Short Physical Performance Battery at 12-month follow-up (P=0.027), compared to controls.

Conclusions: In exploratory analyses, a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients.

Clinical trial registration: URL: http://clinicaltrials.gov. Unique identifier: NCT00693940.

Keywords: exercise; mobility; peripheral artery disease; randomized controlled trial.

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Figures

Figure 1
Figure 1
Overview of study design for the GOALS randomized trial. Adapted with permission from McDermott et al. ABI indicates ankle brachial index; GOALS, Group Oriented Arterial Leg Study; PAD, peripheral artery disease.
Figure 2
Figure 2
Rates of new mobility loss in the exercise and control groups among people with peripheral artery disease. Analyses are limited to people without mobility loss at baseline.
Figure 3
Figure 3
Rates of mobility gain in the exercise and control groups among people with peripheral artery disease. Analyses are limited to people with mobility loss at baseline.
Figure 4
Figure 4
Changes in functional performance in the exercise vs control groups among people with peripheral artery disease.
See this image and copyright information in PMC

References

    1. McDermott MM, Guralnik JM, Ferrucci L, Liu K, Liao Y, Criqui MH. Baseline functional performance predicts the rate of mobility loss in persons with peripheral arterial disease. J Am Coll Cardiol. 2007;50:974–982. - PMC - 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;136:873–883. - 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. 2001;286:1599–1606. - 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. 2004;292:453–461. - PubMed
    1. McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009;301:165–174. - PMC - PubMed

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