MOSAIC (peripheral artery disease)
Trial question
Is a motivating, home-based, walking exercise behavior change intervention superior to usual care for walking in adults with PAD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 190
190 patients (57 female, 133 male).
Inclusion criteria: adult patients with PAD and intermittent claudication.
Key exclusion criteria: unstable intermittent claudication; walking > 90 minutes/week; contraindications to walking exercise; completion of prescribed supervised exercise sessions in the previous 6 months.
Interventions
N=95 motivating structured walking activity treatment (home-based, walking exercise behavior change intervention delivered by physical therapists trained to use a motivational approach).
N=95 usual care (initial assessment, drug therapy, and simple advice to walk provided by a vascular specialist).
Primary outcome
Mean improvement in 6-minute walking distance at 3-month follow-up
27.7 m
2.3 m
27.7 m
20.8 m
13.8 m
6.9 m
0.0 m
Motivating structured walking activity
treatment
Usual
care
Significant
increase ▲
Significantly greater improvement in mean 6MWD at 3-month follow-up (27.7 m vs. 2.3 m; MD 16.7, 95% CI 4.2 to 29.2).
Secondary outcomes
Significantly greater improvement in mean Walking Estimated Limitation Calculated by History score at 6 months (9.8 points vs. 0 points; MD 7.4, 95% CI 2.5 to 12.3).
Significantly greater improvement in mean attitude component of the theory of planned behavior questionnaire score at 6 months (0.7 points vs. -0.7 points; MD 1.4, 95% CI 0.3 to 2.5).
Conclusion
In adult patients with PAD and intermittent claudication, motivating structured walking activity treatment was superior to usual care with respect to mean improvement in 6MWD at 3-month follow-up.
Reference
Lindsay M Bearne, Brittannia Volkmer, Janet Peacock et al. Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial. JAMA. 2022 Apr 12;327(14):1344-1355.
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