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While counseling about walking did not increase step counts for people with peripheral artery disease (PAD), it still was linked to cardiovascular prevention in a post hoc analysis of a small randomized trial.

After a few sessions of advice and goal-setting support face-to-face and over the phone, a significant reduction in major adverse cardiovascular events (MACE 9.8% vs 21.4%, HR 0.43, 95% CI 0.20-0.91) was observed over an average 3.5 years' follow-up compared with controls who got the same amount of attention from non-counseling phone calls.

Notably, the difference seemed to be explained by improvements in disease-specific quality of life (QOL or QoL) at 4 and 12 months. After adjusting for QOL scores, the counseling intervention was no longer significantly associated with a lower risk of MACE, as the BIP trialists led by Jonathan Golledge, MChir, of James Cook University in Townsville, Australia, reported in .

"To our knowledge, the BIP trial is the first randomized clinical trial to show that a physical activity counseling intervention, which also improved QOL, is associated with reduced risk of MACE, a finding which needs to be validated in larger trials," the authors wrote.

That's especially true as the trial missed its primary endpoint, finding that counseling in PAD . It had been thought that improved walking or increased physical activity would be the main way to reduce cardiovascular events in PAD.

"It is plausible that both impaired walking and reduced QOL are independent modifiable risk factors for MACE in people with PAD," Golledge and coauthors wrote. MACE included myocardial infarction (MI), stroke, and cardiovascular death in the study.

Between the intervention and control arms in BIP, a lower risk of MACE was significantly predicted by:

• Intermittent Claudication Questionnaire score (HR per percentage point increase 0.97 at both 4 and 12 months)
• Peripheral Artery Disease Quality of Life domains of symptoms and limitations in physical functioning (HR per unit increase 0.91 at both 4 and 12 months)

"These results align with other studies that found associations between better QoL and improved clinical outcomes, although there is limited evidence for this in PAD," commented Manasi Tannu, MD, MPH, and Jennifer Rymer, MD, MBA, MHS, both of Duke University School of Medicine in Durham, North Carolina.

In an , Tannu and Rymer cited some data that walking is not all that matters in PAD, as home-based walking exercise interventions have increased walking distance without much improvement in QOL.

BIP had been designed to test an intervention aimed at helping patients with the challenges of increasing physical activity. The 200 participants who were randomized all got a pamphlet recommending that they walk for 40 minutes at least three times a week.

The intervention arm was provided with two weekly face-to-face meetings with trained allied health professionals and two subsequent phone calls at weeks 6 and 12. Among the components of the counseling were advice-giving, social support, and encouragement of three 40-minute sessions per week of interval walking at maximum tolerated speed.

"The intervention in the BIP trial focused on assisting participants to understand and self-manage the challenges of exercising with ischemic leg pain. It is possible this led to more acceptance and reduced psychological distress, which then led to less perceived physical disability and pain and, thus, improved QOL and reduced risk of MACE," Golledge and colleagues suggested. Also, "there was a significant reduction in depression and anxiety in participants allocated to the intervention, which could have contributed to the reduced risk of MACE that was identified."

However, attendance for follow-up dropped from 88.0% at 4 months to only a quarter at 6 years. Such large loss to follow-up was a major limitation of the study, which had a small sample to begin with.

"In conclusion, the present analysis presents a compelling hypothesis that improving QoL through counseling interventions may reduce MACE in patients with symptomatic PAD. Future randomized clinical trials may further define the etiology of such interventions in improving MACE, with specific measures for psychological distress and self-care behaviors," according to Tannu and Rymer.

The trial included patients with walking impairment due to PAD recruited from 2015 to 2018 in Australia but excluded people with ischemic rest pain, ulceration, or gangrene.

Those randomized to the control group received phone calls in which they were asked open-ended questions about symptoms and general health but not given any advice -- except to direct any PAD-specific questions to their doctor.

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