A home‐based progressive resistance exercise programme for patients with venous leg ulcers: a feasibility study

Self Cite

180

Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence-based care on the healing rates, functional ability and health-related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12-week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health-related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention-to-treat) analysis to highlight the importance of adherence to an exercise intervention. Intention-to-treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health-related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health-related quality of life), intention-to-treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self-management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.

Section: Discussioncontrasting

confidence: 53%

Evaluating the effectiveness of a self‐management exercise intervention on wound healing, functional ability and health‐related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial

O’Brien

Finlayson

Kerr

et al. 2016

Self Cite

180

“…Some reported healing in groups receiving standard care—at ≤12 weeks, ranging from 23.5% to 45.1%; at 24 weeks: 38.5%; at 6 months: 73.6%; and at 12 months: 67.7% . Some reported healing in groups receiving specialist care—at ≤12 weeks, ranging from 43.6% to 73.0%; and at 24 weeks: 57.6% . In a group receiving specialist care, 96.8% of low‐risk patients and 25.0% of high‐risk patients healed in 24 weeks…”

Section: Resultsmentioning

confidence: 99%

Chronic wounds in Australia: A systematic review of key epidemiological and clinical parameters

McCosker

Tulleners

Cheng

et al. 2018

Chronic wounds are a significant problem in Australia. The health care‐related costs of chronic wounds in Australia are considerable, equivalent to more than AUD $3.5 billion, approximately 2% of national health care expenditure. Chronic wounds can also have a significant negative impact on the health‐related quality of life of affected individuals. Studies have demonstrated that evidence‐based care for chronic wounds improves clinical outcomes. Decision analytical modelling is important in confirming and applying these findings in the Australian context. Epidemiological and clinical data on chronic wounds are required to populate decision analytical models. Although epidemiological and clinical data on chronic wounds in Australia are available, these data have yet to be systematically summarised. To address these omissions and clarify the state of existing evidence, we conducted a systematic review of the literature on key epidemiological and clinical parameters of chronic wounds in Australia. A total of 90 studies were selected for inclusion. This paper presents a synthesis of the evidence on the prevalence and incidence of chronic wounds in Australia, as well as rates of infection, hospitalisation, amputation, healing, and recurrence.

“…Operational factors that prevented authors from achieving their target sample size were reported in 11 studies (40.7%), including a lack of funding ( n = 5), time constraints ( n = 4), and having to compete with other trials concurrently recruiting patients ( n = 3). First, the small amount of funding resources meant that minimal incentives could be provided to the recruitment site, which would be unattractive as “commercially funded trials often offer reimbursement to the host institution at a 10‐20‐fold greater level” than what researchers could offer .…”

Section: Resultsmentioning

confidence: 99%

“…Of all the included studies, 5 reported to have extended the recruitment period, but only 1 study attained the target sample size, and the rest did not . Third, concurrent trials impacted the number of eligible patients that could be approached . Idris and colleagues found that, of those who were seen at the recruitment site, “29% were debarred by involvement in other studies” …”

Section: Resultsmentioning

confidence: 99%

Barriers and enablers to patient recruitment for randomised controlled trials on treatment of chronic wounds: A systematic review

Bugeja

Low

McGinnes

et al. 2018

Randomised controlled trials represent the gold standard in intervention efficacy evaluation. However, suboptimal recruitment affects completion and the power of a therapeutic trial in detecting treatment differences. We conducted a systematic review to examine the barriers and enablers to patient recruitment for randomised controlled trials on chronic wound treatment. Review registration was under PROSPERO 2017:CRD42017062438. We conducted a systematic search of Ovid MEDLINE, EBSCOhost CINAHL, Ovid Cochrane Library, Ovid EMBASE, and Ovid PsycINFO databases in June 2017 for chronic wound treatment randomised controlled trials. Twenty-seven randomised controlled trials or qualitative studies met the inclusion criteria. Among the 24 randomised controlled trials, 21 were assessed as low quality in relation to recruitment, and 3 were assessed as high quality. All 27 studies reported barriers to recruitment in chronic wound randomised controlled trials. The reported barriers to recruitment were: study-related, patient-related, clinician-related, health system-related, and/or operational-related. No study reported recruitment enablers. To enhance randomised controlled trial recruitment, we propose the need for improved integration of research and clinical practice. To alleviate the problems arising from inadequate reporting of randomised controlled trials, the Consolidated Standards of Reporting Trials Statement could include an additional item on recruitment barriers. This approach will allow for increased awareness of the potential barriers to recruitment for Randomised controlled trials (RCTs) in both wound management and other health care research.