Chronic low back pain (CLBP) is a major cause of global disability and improving management is essential. Acceptance and commitment therapy (ACT) is a promising treatment for chronic pain but has not been modified for physical therapy. This randomized controlled trial (RCT) compared physical therapy informed by ACT (PACT) against standard care physical therapy for patients with CLBP. Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in 4 UK public hospitals. The Roland-Morris Disability Questionnaire (RMDQ) at 3 months' postrandomization was the primary outcome. Two hundred forty-eight participants (59% female, mean age = 48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference = 1.07, p = .037, 95% CI = À2.08 to À.07, d = .2), Patient Specific Functioning (p = .008), SF12 physical health (p = .032), and treatment credibility (p < .001). At 12 months' follow-up, there were no significant differences between groups. PACT was acceptable to patients and clinicians and feasible to deliver. Physical therapists incorporated psychological principles successfully and treatment was delivered with high (≥80%) fidelity. Our results may inform the management of CLBP, with potential benefits for patients, health care providers, and society.Perspective: Psychologically informed physical therapy has great potential but there are challenges in implementation. The training and support included in the PACT trial enabled the intervention to be delivered as planned. This successfully reduced disability in the short but not long term. Findings could inform physical therapists' treatment of CLBP.
Walking is an effective but underused treatment for intermittent claudication (IC). This qualitative study explored people's experiences of and beliefs about their illness and walking with IC. Using
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.
IntroductionChronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP.Methods and analysisThe PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model.Ethics and disseminationThis trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP.Trial registration numberISRCTN95392287; Pre-results.
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.
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
Intermittent claudication is debilitating leg pain affecting older people with peripheral arterial disease, which is improved by regular walking. This study evaluated associations between psychosocial variables and 6-min walk distance (6MWD) to identify factors that motivate walking. A total of 142 individuals with intermittent claudication (116 males; Mage = 66.9 years [SD = 10.2]) completed cross-sectional assessments of sociodemographics, walking treatment beliefs and intention (Theory of Planned Behaviour), illness perceptions (Revised Illness Perceptions Questionnaire), and 6MWD. Multiple linear regression was used to evaluate relationships among psychosocial variables (treatment beliefs and illness perceptions) and outcomes (walking intention and 6MWD). Theory of planned behavior constructs were associated with intention (R = .72, p < .001) and 6MWD (R = .08, p < .001). Illness perceptions were associated with 6MWD only (R = .27, p < .001). Intention (β = 0.26), treatment control (β = −0.27), personal control (β = 0.32), coherence (β = 0.18), and risk factor attributions (β = 0.22; all ps < .05) were independently associated with 6MWD. Treatment beliefs and illness perceptions associated with intention and 6MWD in people with intermittent claudication are potential intervention targets.
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