The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease.
Study Goal
The researchers aimed to compare the effectiveness of an internet-based walking program, telephone counseling, or their combination in promoting regular walking among adults with peripheral arterial disease (PAD).
Results Summary
The study is ongoing, but it aims to assess walking distance, step-counts, pain-free walking distance, and health-related quality of life changes from baseline to follow-up. The abstract does not yet report specific results.
Population
Sedentary adults with documented lower extremity PAD.
Effective Dosage
Not specified (intervention involves tailored step-count goals).
Duration
4-month intervention phase with an additional 8-month follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
internet-based walking program | increase | promotion of regular walking | patients with PAD | - | examine the effectiveness | #1 |
telephone intervention | increase | promotion of regular walking | patients with PAD | - | examine the effectiveness | #2 |
combination (internet-based with telephone counseling) | increase | promotion of regular walking | patients with PAD | - | examine the effectiveness | #3 |
telephone counseling to promote walking | increase | regular walking | Sedentary adults with documented lower extremity PAD | - | promote walking | #4 |
internet-based walking program with tailored step-count goals | increase | regular walking | Sedentary adults with documented lower extremity PAD | - | promote walking | #5 |
combination of telephone counseling with the internet-based walking program | increase | regular walking | Sedentary adults with documented lower extremity PAD | - | promote walking | #6 |
4-month intervention phase | increase | regular walking | participants | - | assess long-term adherence | #7 |
internet based programs with and without telephone counseling | increase | regular walking | PAD patients | - | promote regular walking | #8 |
BACKGROUND: Despite established guidelines for regular walking as a first line therapy for adults with peripheral arterial disease (PAD), most patients do not walk routinely. This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a telephone intervention, or the combination (internet-based with telephone counseling) for promotion of regular walking in patients with PAD. METHODS: Sedentary adults with documented lower extremity PAD are being recruited from the University of Michigan Health System and the surrounding area. Participants are randomized to one of four arms in a 2×2 factorial design: 1) telephone counseling to promote walking, 2) an internet-based walking program with tailored step-count goals, 3) the combination of telephone counseling with the internet-based walking program, or 4) waitlist control. Participants receive a 4-month intervention phase, after which all participants are followed for an additional 8months to assess long-term adherence to regular walking. Outcomes are assessed at baseline, 4 and 12months. The primary outcome is walking distance assessed through a standardized treadmill protocol. Additional outcomes include change in step-counts measured with a commercial activity tracker, pain-free walking distance, and changes in health-related quality of life from baseline to follow-up. CONCLUSION: Finding effective and feasible programs to promote walking among PAD patients is warranted. This study will add to current evidence regarding use of internet based programs with and without telephone counseling to promote regular walking in this population.