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

Mary M McDermott, Jack M Guralnik, Michael H Criqui, Luigi Ferrucci, Kiang Liu, Bonnie Spring, Lu Tian, Kathryn Domanchuk, Melina Kibbe, Lihui Zhao, Donald Lloyd Jones, Yihua Liao, Ying Gao, W Jack Rejeski, Mary M McDermott, Jack M Guralnik, Michael H Criqui, Luigi Ferrucci, Kiang Liu, Bonnie Spring, Lu Tian, Kathryn Domanchuk, Melina Kibbe, Lihui Zhao, Donald Lloyd Jones, Yihua Liao, Ying Gao, W Jack Rejeski

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: https://ichgcp.net/clinical-trials-registry/NCT00693940" title="See in ClinicalTrials.gov">NCT00693940.

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

© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

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.

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Source: PubMed

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