A systematic review of exercise intervention reporting quality and dose in studies of intermittent claudication.

BACKGROUND: Exercise therapy is an important treatment option for people with intermittent claudication (IC). Appropriate reporting of exercise interventions in populations with IC within randomised controlled trials (RCTs) is important to ensure that research can be translated into clinical practice. Therefore, the purpose of our review is to evaluate the reporting of exercise interventions in RCTs of exercise therapy in patients with IC. METHODS: A systematic search was performed to identify relevant trials in patients with IC published until May 2020. Studies including only participants with critical limb ischaemia or asymptomatic peripheral artery disease were excluded. Each trial was scored using the recently developed 'Consensus on Exercise Reporting Template' (CERT) which has a maximum obtainable score of 19. RESULTS: Of 1489 unique records identified from the search, 73 trials were included, reporting 107 exercise interventions. Overall, the average CERT score was 10/19. The exercise equipment used, the use of supervision and a description of whether the exercise prescription was tailored or generic were the most frequently reported intervention components. The motivational strategies used, intervention adherence and intervention fidelity were the most underreported CERT components. There was no trend indicating that CERT scores were higher in more recent publications. CONCLUSIONS: We have identified that important details about exercise interventions are frequently missing from the published literature. These missing data hinder replication of research findings and limit the translation of evidence into clinical practice.

The effect of resistance training on functional capacity in middle-aged to elderly individuals with peripheral artery disease: a meta-analysis.

INTRODUCTION: Peripheral artery disease (PAD) is an ischemic disease of the lower limbs, caused by atherosclerotic plaques, leading to impairments in functional capacity and reduced quality of life. This meta-analysis aimed to assess the effect of 12-week and 24-week resistance training (RT) interventions on 6-minute walking distance (6WMD) and initial claudication distance (ICD) measured during a 6-minute walk test (6MWT). EVIDENCE ACQUISITION: A meta-analysis was conducted in accordance with PRISMA guidelines, with an electronic search conducted using the online database of PUBMED. Methodological quality of all included studies was completed using a modified version of the Newcastle Ottawa Scale (NOS). The effect sizes (ES) of 6MWD and ICD were calculated, with the 12-week and 24-week interventions analyzed separately. EVIDENCE SYNTHESIS: An initial literature search yielded 1973 results that were consequently reduced to 7 studies to be included in the final meta-analysis. The pooled effect size for 6MWD for 12-week and 24-week interventions was ES=0.189 [95% CI: -0.074 to 0.451] P=0.159 and ES=0.298 [95% CI: -0.036 to 0.631] P=0.080 respectively. For ICD, ES=0.498 [95% CI: 0.000 to 0.995] P=0.050 and ES: 1.106 [95% CI: 0.120 to 0.428] P=0.001 respectively. CONCLUSIONS: Short-term RT interventions have a positive effect on functional capacity in middle-aged to elderly individuals with PAD. There was a greater effect on ICD compared to 6MWD, with 24-week interventions showing larger effects for both measures. Improvements in functional capacity in such populations confers significant potential for positive health outcomes.

Effects of exercise prescribed at different levels of claudication pain on walking performance in patients with intermittent claudication: a protocol for a randomised controlled trial.

BACKGROUND: Peripheral artery disease affects over 236 million people globally and the classic symptom is intermittent claudication (IC) which is associated with reduction in physical activity. The evidence that supervised exercise programmes (SEPs) improve pain-free and maximal walking distance is irrefutable. However, adherence rates are low with exercise-related pain cited as a contributing factor. National and international guidelines recommend exercising at a moderate to maximal level of claudication pain to improve walking ability; however, exercising pain-free or at mild claudication pain has been shown to achieve this outcome. There is limited evidence that compares the relative effects of exercise prescribed at different levels of claudication pain. OBJECTIVE: The objective of this study is to directly compare the effects of exercise prescribed at three different levels of claudication pain on walking performance. DESIGN: This study will be a single-centre randomised controlled trial. METHODS: Based on an a priori power calculation, 51 patients with IC will be allocated to 24 weeks of twice-weekly pain-free (PF), moderate pain (MOD-P) or maximal pain (MAX-P) exercise. The PF group will cease exercise at the onset of claudication (1 on the 0-4 IC rating scale), the MOD-P group will stop once moderate pain is reached (2 on the rating scale) and the MAX-P group will stop once maximal pain is reached (4 on the rating scale). ANALYSIS: Outcome measures will be assessed at baseline, 12 and 24 weeks adopting an analysis of covariance (ANCOVA) to compare MWD across three time points. The primary outcome for the trial will be change in maximal treadmill walking distance at 12 and 24 weeks. REGISTRATION: Trial registration number: NCT04370327.

A Systematic Review of Exercise Prescription in Patients with Intermittent Claudication: Does Pain Matter?

BACKGROUND: Current guidelines for intermittent claudication advocate exercise at moderate to maximal claudication pain. However, adherence rates to supervised exercise programmes (SEP) remain poor and claudication pain is a contributing factor. Limited evidence suggests that moderate or pain-free exercise may be just as beneficial and may be better tolerated. However, it remains unclear what 'level' of claudication pain is optimal for improving functional outcomes. We therefore conducted a systematic review to synthesise the evidence for exercise prescribed at different levels of claudication pain. METHODS: The CENTRAL, MEDLINE, Embase and CINAHL databases were searched up to October 2020. Randomized controlled trials (RCTs) that directly compared at least 2 different intensities of claudication pain were included. Outcome measures included walking performance, adherence, quality of life and vascular function. RESULTS: Of 1,543 search results, 2 studies were included. Maximal walking distance improved by 100-128% in the moderate-pain SEP groups, and by 77-90% in the pain-free SEP groups. Importantly, there were no significant differences between the moderate-pain and pain-free SEP groups in either study for improvements in walking performance, though comparison to a maximal-pain SEP group was not made. CONCLUSIONS: The efficacy of SEPs for patients with intermittent claudication is irrefutable, though there is no consensus on the optimal level of pain. Therefore, adequately powered RCTs are required to compare the effect of pain-free SEPs, moderate-pain SEPs and maximal-pain SEPs on functional outcomes. (PROSPERO ID: CRD42020213684).

A systematic review of exercise testing in patients with intermittent claudication: A focus on test standardisation and reporting quality in randomised controlled trials of exercise interventions.

A systematic review was conducted to identify the range of terminology used in studies to describe maximum walking distance and the exercise testing protocols, and testing modalities used to measure it in patients with intermittent claudication. A secondary aim was to assess the implementation and reporting of the exercise testing protocols. CINAHL, Medline, EMBASE and Cochrane CENTRAL databases were searched. Randomised controlled trials whereby patients with intermittent claudication were randomised to an exercise intervention were included. The terminology used to describe maximal walking distance was recorded, as was the modality and protocol used to measure it. The implementation and reporting quality was also assessed using pre-specified criteria. Sixty-four trials were included in this review. Maximal walking distance was reported using fourteen different terminologies. Twenty-two different treadmill protocols and three different corridor tests were employed to assess maximal walking distance. No single trial satisfied all the implementation and reporting criteria for an exercise testing protocol. Evidence shows that between-study interpretation is difficult given the heterogenous nature of the exercise testing protocols, test endpoints and terminology used to describe maximal walking distance. This is further compounded by poor test reporting and implementation across studies. Comprehensive guidelines need to be provided to enable a standardised approach to exercise testing in patients with intermittent claudication.

Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: A protocol for a pilot study.

INTRODUCTION: Current UK guidance for the treatment of intermittent claudication (IC) states that supervised exercise programmes (SEPs) should be offered as first-line treatment [1], prior to surgical interventions. However, there is currently a national shortage of dedicated SEPs. It has been suggested that the established network of UK Cardiac Rehabilitation (CR) programmes could cater for IC patients. This study will investigate the feasibility of combining IC and CR patients into one SEP, and explore the patient perception's regarding the treatment programme, to establish whether CR could potentially fill the gap in service provision. METHODS AND ANALYSIS: Patients diagnosed with IC will be incorporated into a CR programme where they will exercise alongside patients with coronary artery disease (CAD). Participants will attend a 2-h class, once a week for a total of 12 weeks. Another group of IC patients will attend an SEP consisting solely of other IC patients (control group). OUTCOME MEASURES: The study will evaluate the feasibility of recruitment, retention, and participant experience of the intervention as well as physiological outcomes (primary outcome: pain-free walking, and maximal walking distance; secondary outcomes: physical activity levels, perceived walking ability, and disease-specific quality of life). Outcomes will be assessed at baseline and on completion of the SEP. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from North West- Greater Manchester West Research Ethics Committee on 13th June 2018 (IRAS ID: 230391). This study is registered with clinicaltrials. gov (NCT03564080) and conforms to the Declaration of Helsinki. Results will be disseminated via national conferences and published in peer-reviewed journals.