A randomized controlled feasibility trial of a home-based walking behavior–change intervention for people with intermittent claudication

Abstract

L. M. (2019). A randomized controlled feasibility trial of a home-based walking behavior-change intervention for people with intermittent claudication. JOURNAL OF VASCULAR NURSING, 37(2), 135-143. https://doi. ABSTRACTWalking treatment is recommended for improving intermittent claudication (IC), a debilitating symptom of leg pain caused by peripheral arterial disease. However, centre-based exercise programmes offered in a community or hospital setting are often not implemented or adhered to. We developed a home-delivered behaviour-change intervention, Motivating Structured walking Activity in Intermittent Claudication (MOSAIC), to increase walking in people with IC. A feasibility randomised controlled trial with nested qualitative interviews involving a subsample of trial participants was conducted. Feasibility criteria evaluated a) participant recruitment and retention; b) suitability of proposed outcome measures; and c) acceptability and adherence to the intervention and trial. Participants (adults ≥18 years diagnosed with IC identified from vascular outpatient clinics) were randomised 1:1 to receive MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behaviour-change techniques) or an attentioncontrol comparison. Outcomes (baseline and 16-week follow-up) included: the 6-Minute Walk Distance (metres), pedometer-assessed daily walking activity (steps/day), health related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and selfregulatory processes. 24 Participants (mean age 66.8 ±9.4 years, 79% male) were included.Feasibility criteria achieved were: recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%). Missing data rates were <10% for all outcomes except baseline daily walking activity (36%). The trial protocol and interventions were acceptable to participants and the clinician. In conclusion, the MOSAIC trial was feasible to conduct, with the exception of high missing pedometer data. The intervention is an acceptable approach to facilitate walking among people with IC.

Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study

“…Furthermore, this study also included a feasibility evaluation of the different assessments. Our findings were in line with earlier publications, that is, 2 recent studies also reported difficulties (55% and 50% baseline and follow-up data, respectively [ 43 , 45 ]) in collecting physical activity data using a triaxial pedometer or accelerometer on the hip. A possible explanation for these missing values might be the instruction to wear the monitor during waking hours compared with a more compliant 24-hour protocol [ 55 ].…”

“…Despite the short intervention duration, a clinically relevant improvement was found in the WIQ distance score [ 41 ]. As this study was designed to primarily evaluate patients’ satisfaction and acceptance, our results complement contemporary pilot studies in the field of eHealth solutions in patients with IC [ 20 , 42 - 45 ] .…”

An updated systematic review and meta-analysis of home-based exercise programs for individuals with intermittent claudication

“…Of the included trials, three were non-randomised and compared HEPs with SEPs . The 28,30,36,38,[41][42][43]45,47 remaining trials were RCT's, with nine comparing HEPs with SEPs , three comparing HEPs with basic exercise advice 31,32,48 , two comparing HEPs with both these groups 18,46 and six comparing HEPs to no exercise controls 17,19,29,39,49,50 .…”

Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication

“…MOSAIC was systematically developed to target the salient factors identified from these two models12 23 and includes behavioural change techniques to facilitate the uptake and maintenance of walking exercise 24. This protocol was informed by a preliminary study which demonstrated that the MOSAIC intervention and trial procedures were acceptable to participants and clinicians and feasible to deliver 26…”

“…Crucial conditions to support health behavioural change, such as increasing self-directed walking exercise, are an individual’s capability (eg, knowledge and understanding that walking exercise is a treatment for intermittent claudication), opportunity (eg, identifying an appropriate environment place to walk) and motivation (eg, attitudes and beliefs about walking as a treatment) 21–23. Evidence suggests that targeting these factors using behavioural change techniques (eg, setting walking goals, action planning22 24 or motivational interviewing25) in addition to exercise or advice may increase walking ability in people with intermittent claudication 24 26…”