Does a physical therapist-led, home-based walking exercise behavior change intervention improve walking capacity compared with usual care in adults with peripheral artery disease and intermittent claudication? FindingsIn this randomized clinical trial that included 190 participants with intermittent claudication due to peripheral artery disease, receipt of the intervention, compared with usual care, resulted in a statistically significant adjusted difference in mean six-minute walk distance at 3-months of 16.7m. MeaningAmong adults with peripheral artery disease, a home-based walking exercise behavior change intervention, compared with usual care, increased six-minute walking distance at 3-months.
IntroductionWalking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.Methods and analysisThe MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.Ethics and disseminationThis trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.Trial registration numberISRCTN14501418
To the Editor A recent study 1 demonstrated a greater improvement in 6-minute walk distance, self-reported walking ability, pain-free walking time, exercise-related behavior, and quality of life following 3 months of combined home-based, walking and exercise behavior counseling intervention compared with usual care in patients with peripheral artery disease (PAD). We have some concerns about this study's protocol.First, the patients' physical activity was subjectively assessed using the short form of the International Physical Activity Questionnaire, which was recently shown to overestimate physical activity and underestimate sedentary behavior compared with accelerometry in patients with coronary artery disease. 2 The same discrepancies between objectively and subjectively assessed physical activity have also been shown in patients with PAD. 3 Because greater than 40% of the patients in this study 1 had cardiovascular disease along with PAD, we believe that overestimation of physical activity could have occurred in this trial. This potential overestimation may have affected the enrollment process because all patients who walked more than 90 minutes per week, according to the brief physical activity questionnaire, were excluded from the study. In addition, the absence of posttraining improvement in physical activity may also have been influenced by an overestimation of self-reported physical activity at baseline.Second, the exercise adherence in this study 1 was monitored using pedometers, which have limited measurement characteristics (measuring only step count and distance) compared with triaxial accelerometry. Therefore, use of pedometers may have limited the optimal training adjustment of walking intensity, which is used to elicit greater improvements in maximal walking distance and pain-free walking, and is wellestablished to be associated with lower risk of cardiovascular and all-cause mortality. 4 With increasing use of accelerometers in cardiovascular rehabilitation, 5 we are proponents of objective assessment of daily sedentary behavior, walking, and different levels of physical activity to monitor and study the effects of home-based exercise training interventions. Accelerometer-or pedometerguided exercise therapy is established in patients with coronary artery disease. 5 Therefore, we believe that exercise therapy for PAD should follow in these footsteps to investigate whether the same principles can be applied.
Objective This study aimed to explore the experience and impact of fatigue in adults with primary antiphospholipid syndrome (pAPS). Methods This sequential, explanatory mixed-methods study enrolled adults with a six-month or more history of pAPS. Consenting participants completed the Functional Assessment of Chronic Illness Therapy–Fatigue subscale (FS), Multi-Dimensional Perceived Social Support Scale, Patient Health Questionnaire (PHQ9), Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQMETS). Relationships between FS and other variables were explored with multiple linear regression. Interviews were conducted with a subgroup of participants, and the data were analysed thematically. Results A total of 103 participants were recruited ( Mage = 50.3 years; standard deviation = 10.1 years; 18 males). Of these, 62% reported severe fatigue. Greater fatigue was associated with lower mood, physical inactivity, poorer sleep quality and lower perceived social support. The best-fit model explained 56% of the variance in FS (adjusted R2 = 0.560, F(3, 74) = 33.65, p > 0.001) and included PHQ9 and IPAQMETS as significant predictors, and PSQI as a non-significant predictor. Twenty participants completed interviews. Three key themes were identified: characteristics of fatigue, impact on life and coping strategies. Conclusion Fatigue was a common symptom of pAPS and challenging to manage. Other factors, particularly mood and physical activity, influenced fatigue. Evidence-based self-management interventions are needed.
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