Participants' experiences and acceptability of a home-based walking exercise behaviour-change intervention (MOtivating Structure walking Activity in people with Intermittent Claudication (MOSAIC)).

OBJECTIVES: This study explored the experiences and acceptability of a novel, home-based, walking exercise behaviour-change intervention (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in adults with Peripheral Arterial Disease (PAD). DESIGN AND SETTING: Individual semi-structured audio-recorded interviews were conducted with adults with Peripheral Arterial Disease who had completed the MOSAIC intervention as part of a randomised clinical trial. Data were analysed using inductive reflexive thematic analysis and interpreted using the seven-construct theoretical framework of acceptability of healthcare interventions (TFA). PARTICIPANTS: Twenty participants (mean age (range) 67(54-80) years, 70% male, 55% White British) were interviewed. RESULTS: One central theme was identified: Acceptability of walking exercise as a treatment. This theme was explained by four linked themes: Exploring walking exercise with a knowledgeable professional, Building confidence with each step, Towards self-management-learning strategies to continue walking and The impact of walking exercise. These themes were interpreted using six of the seven TFA constructs: affective attitude, burden, perceived effectiveness, intervention coherence, opportunity costs, and self-efficacy. CONCLUSIONS: Participants perceived MOSAIC as an effective, acceptable, and low burden intervention. Physiotherapists were regarded as knowledgeable and supportive professionals who helped participants understand PAD and walking exercise as a treatment. Participants developed confidence to self-manage their condition and their symptoms. As participants confidence and walking capacity improved, they expanded their activities and gained a more positive outlook on their future. MOSAIC is an acceptable intervention that may facilitate adoption of and access to exercise for people with PAD.

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.

Importance: Home-based walking exercise interventions are recommended for people with peripheral artery disease (PAD), but evidence of their efficacy has been mixed. Objective: To investigate the effect of a home-based, walking exercise behavior change intervention delivered by physical therapists in adults with PAD and intermittent claudication compared with usual care. Design, Setting, and Participants: Multicenter randomized clinical trial including 190 adults with PAD and intermittent claudication in 6 hospitals in the United Kingdom between January 2018 and March 2020; final follow-up was September 8, 2020. Interventions: Participants were randomized to receive a walking exercise behavior change intervention delivered by physical therapists trained to use a motivational approach (n = 95) or usual care (n = 95). Main Outcomes and Measures: The primary outcome was 6-minute walking distance at 3-month follow-up (minimal clinically important difference, 8-20 m). There were 8 secondary outcomes, 3 of which were the Walking Estimated Limitation Calculated by History (WELCH) questionnaire (score range, 0 [best performance] to 100), the Brief Illness Perceptions Questionnaire (score range, 0 to 80 [80 indicates negative perception of illness]), and the Theory of Planned Behavior Questionnaire (score range, 3 to 21 [21 indicates best attitude, subjective norms, perceived behavioral control, or intentions]); a minimal clinically important difference was not defined for these instruments. Results: Among 190 randomized participants (mean age 68 years, 30% women, 79% White race, mean baseline 6-minute walking distance, 361.0 m), 148 (78%) completed 3-month follow-up. The 6-minute walking distance changed from 352.9 m at baseline to 380.6 m at 3 months in the intervention group and from 369.8 m to 372.1 m in the usual care group (adjusted mean between-group difference, 16.7 m [95% CI, 4.2 m to 29.2 m]; P = .009). Of the 8 secondary outcomes, 5 were not statistically significant. At 6-month follow-up, baseline WELCH scores changed from 18.0 to 27.8 in the intervention group and from 20.7 to 20.7 in the usual care group (adjusted mean between-group difference, 7.4 [95% CI, 2.5 to 12.3]; P = .003), scores on the Brief Illness Perceptions Questionnaire changed from 45.7 to 38.9 in the intervention group and from 44.0 to 45.8 in the usual care group (adjusted mean between-group difference, -6.6 [95% CI, -9.9 to -3.4]; P < .001), and scores on the attitude component of the Theory of Planned Behavior Questionnaire changed from 14.7 to 15.4 in the intervention group and from 14.6 to 13.9 in the usual care group (adjusted mean between-group difference, 1.4 [95% CI, 0.3 to 2.5]; P = .02). Thirteen serious adverse events occurred in the intervention group, compared with 3 in the usual care group. All were determined to be unrelated or unlikely to be related to the study. Conclusions and Relevance: Among adults with PAD and intermittent claudication, a home-based, walking exercise behavior change intervention, compared with usual care, resulted in improved walking distance at 3 months. Further research is needed to determine the durability of these findings. Trial Registrations: ISRCTN Identifier: 14501418; ClinicalTrials.gov Identifier: NCT03238222.

Physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: A mixed-methods treatment fidelity evaluation.

OBJECTIVES: A randomized controlled trial of a new type of Physiotherapy informed by Acceptance and Commitment Therapy (PACT), found that it improved functioning in people with chronic low back pain compared to usual physiotherapy care. Fidelity evaluation is necessary to understand trial processes and outcomes. This study evaluated PACT treatment fidelity including delivery, receipt, and enactment. DESIGN: A mixed-methods study nested within a randomized controlled trial was conducted. METHODS: A total of 72 (20% of total) PACT treatment audio files were independently assessed by two raters, according to a novel framework developed to measure PACT treatment content adherence, therapeutic alliance, ACT competence, and treatment enactment. Interview transcripts from 19 trial participants randomized to PACT were analysed thematically for evidence of treatment receipt and enactment. RESULTS: PACT physiotherapists delivered treatment as intended with high content adherence and satisfactory therapeutic alliance, but ACT competence was low. Qualitative findings indicated participant receipt of 11/17 and enactment of 3/17 components; 89% (n = 17) and 47% (n = 9) of participants reported treatment receipt and enactment of at least one component, respectively. CONCLUSIONS: This mixed-methods study of PACT treatment demonstrated high fidelity reflecting treatment content delivery and receipt, and therapeutic alliance. There was some evidence of treatment enactment in participants with chronic low back pain. Low ACT competence could be addressed through additional support and adaptations to therapeutic processes for delivery by physiotherapists.

Experiences of training and delivery of Physical therapy informed by Acceptance and Commitment Therapy (PACT): a longitudinal qualitative study.

OBJECTIVES: Physiotherapy informed by Acceptance and Commitment Therapy (PACT) is a novel intervention that is related to improved disability and functioning in people with chronic lowback pain. This study explored physiotherapists experiences over time of the PACT training programme and intervention delivery. DESIGN: A longitudinal qualitative study using semi-structured, in-depth, individual interviews at three time points was conducted. METHODS: A phenomenological approach underpinned the methods. Interviews followed topic-guides developed a priori. Transcribed interviews were coded inductively to generate themes. Data were member checked by participants and validated by two researchers. PARTICIPANTS: Eight clinical physiotherapists from three secondary care centres in the United Kingdom (n = 5 female; age, 24 to 44 years; duration of practice, 3 to 14 years) were included. RESULTS: Five themes emerged from the data. Experiential learning techniques were challenging but valued because they bridged theoretical principles and concepts with practice. Ongoing individual and group supervision was beneficial, but required tailoring and tapering. PACT delivery extended physiotherapy skills and practice, including techniques that acknowledged and addressed patient treatment expectations. With experience, participants desired greater flexibility and autonomy to tailor PACT delivery. CONCLUSIONS: PACT training and delivery were acceptable to physiotherapists. Existing skills were developed and additional, applicable approaches were provided that addressed psychosocial and behavioural aspects of chronic low back pain.

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

Walking treatment is recommended for improving intermittent claudication (IC), a debilitating symptom of leg pain caused by peripheral arterial disease. However, center-based exercise programs offered in a community or hospital setting are often not implemented or adhered to. We developed a home-delivered behavior-change intervention, MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC), to increase walking in people with IC. A feasibility randomized controlled trial with nested qualitative interviews involving a subsample of trial participants was conducted. Feasibility criteria evaluated participant recruitment and retention; suitability of proposed outcome measures; and acceptability and adherence to the intervention and trial. Participants (adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics) were randomized 1:1 to receive MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behavior-change techniques) or an attention-control comparison. Outcomes (baseline and 16-week follow-up) included the 6-minute walking distance (meters), pedometer-assessed daily walking activity (steps/d), health-related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and self-regulatory processes. Twenty-four 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 for 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.

Effect of patellofemoral pain on foot posture and walking kinematics.

Background Excessive pronation has been implicated in patellofemoral pain (PFP) aetiology and foot orthoses are commonly prescribed for PFP patients. Pronation can be assessed using foot posture tests, however, the utility of such tests depends on their association with foot and lower-limb kinematics. Research questions Do PFP participants compared with healthy participants (1) have a more pronated foot measured with static foot tests and a kinematic multi-segmental foot model and (2) is there an association between static foot posture and foot and lower limb kinematics during walking? Methods A case-control study including 22 participants (n = 11 PFP, 5 females per group, aged 24 ± 3 (mean ± SD) years) was conducted. Foot posture measures included Arch Height Ratio, Navicular Drop (ND), and Foot Posture Index. Between-group comparisons of foot posture, segment and joint angle magnitudes, and associations between foot posture and kinematic data during gait were evaluated. Results There were no group differences in foot posture tests and mean joint angles. PFP participants had greater internal rotation of the shank and rearfoot segments, and adduction of the mid- and forefoot in the transverse plane (all p < 0.05). Greater ND was associated with increased forefoot abduction (rho=-0.68, p = 0.02) in healthy participants but no relationships were found between foot posture and kinematics in PFP participants. Significance Foot posture and kinematic data did not indicate excessive pronation in PFP participants questioning the use of orthoses to correct pronation. Larger studies are needed to determine the utility of foot posture tests as indicators of gait abnormalities in PFP.

Are Walking Treatment Beliefs and Illness Perceptions Associated With Walking Intention and 6-Min Walk Distance in People With Intermittent Claudication? A Cross-Sectional Study.

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 (ß = 0.26), treatment control (ß = -0.27), personal control (ß = 0.32), coherence (ß = 0.18), and risk factor attributions (ß = 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.

'You can't walk with cramp!' A qualitative exploration of individuals' beliefs and experiences of walking as treatment for intermittent claudication.

Walking is an effective but underused treatment for intermittent claudication. This qualitative study explored people's experiences of and beliefs about their illness and walking with intermittent claudication. Using the Framework method, semi-structured in-depth interviews included 19 individuals with intermittent claudication, and were informed by the Theory of Planned Behaviour and Common Sense Model of Illness Representations. Walking was overlooked as a self-management opportunity, regardless of perceptions of intermittent claudication as severe or benign. Participants desired tailored advice, including purposeful and vigorous exercise, and the potential outcome of walking. Uncertainties about their illness and treatment may explain low walking participation among people with intermittent claudication.