Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial

Abstract

Importance: Clinical practice guidelines state there is insufficient evidence to support advising patients with peripheral artery disease (PAD) to participate in a home-based walking exercise program.

Objective: To determine whether a home-based walking exercise program that uses a group-mediated cognitive behavioral intervention, incorporating both group support and self-regulatory skills, can improve functional performance compared with a health education control group in patients with PAD with and without intermittent claudication.

Design, setting, and patients: Randomized controlled clinical trial of 194 patients with PAD, including 72.2% without classic symptoms of intermittent claudication, performed in Chicago, Illinois between July 22, 2008, and December 14, 2012.

Interventions: Participants were randomized to 1 of 2 parallel groups: a home-based group-mediated cognitive behavioral walking intervention or an attention control condition.

Main outcomes and measures: The primary outcome was 6-month change in 6-minute walk performance. Secondary outcomes included 6-month change in treadmill walking, physical activity, the Walking Impairment Questionnaire (WIQ), and Physical and Mental Health Composite Scores from the 12-item Short-Form Health Survey.

Results: Participants randomized to the intervention group significantly increased their 6-minute walk distance ([reported in meters] 357.4 to 399.8 vs 353.3 to 342.2 for those in the control group; mean difference, 53.5 [95% CI, 33.2 to 73.8]; P < .001), maximal treadmill walking time (intervention, 7.91 to 9.44 minutes vs control, 7.56 to 8.09; mean difference, 1.01 minutes [95% CI, 0.07 to 1.95]; P = .04), accelerometer-measured physical activity over 7 days (intervention, 778.0 to 866.1 vs control, 671.6 to 645.0; mean difference, 114.7 activity units [95% CI, 12.82 to 216.5]; P = .03), WIQ distance score (intervention, 35.3 to 47.4 vs control, 33.3 to 34.4; mean difference, 11.1 [95% CI, 3.9 to 18.1]; P = .003), and WIQ speed score (intervention, 36.1 to 47.7 vs control, 35.3-36.6; mean difference, 10.4 [95% CI, 3.4 to 17.4]; P = .004).

Conclusion and relevance: A home-based walking exercise program significantly improved walking endurance, physical activity, and patient-perceived walking endurance and speed in PAD participants with and without classic claudication symptoms. These findings have implications for the large number of patients with PAD who are unable or unwilling to participate in supervised exercise programs.

Trial registration: clinicaltrials.gov Identifier: NCT00693940.

Conflict of interest statement

Conflict of Interest Disclosures

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr McDermott reports being a medical editor for the Foundation for Informed Medical Decision Making, consulting for Ironwood Pharmaceuticals, and receipt of travel expenses from the American Heart Association as an SACC member. Dr Spring reports board membership with Actigraph. No other disclosures were reported.

Figures

Figure 1

Study Participation and Follow-up for the Group-Oriented Arterial Leg Study (GOALS)

Figure 2

Association Between Home-Based Walking Exercise Intervention and Change in 6-Minute Walk at 6-Month Follow-up Within Subsets of GOALS Participants. Change in 6-minute walk is shown for specific subsets of participants within the Group-Oriented Arterial Leg Study (GOALS) according to whether they were randomized to the intervention vs control group. P values represent the change in 6-minute walk between the intervention vs control group for each study characteristic. Error bars indicate 95% CIs.