A Mixed Methods Study of Cross-sectoral Rehabilitation Intervention for Patients with Intermittent Claudication Versus Usual Care for Patients in Non-operative Management. -The Cipic Rehab Study

Abstract

Introduction: The study examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients conservatively treated for intermittent claudication (IC). Peripheral Artery Disease is one of the most prevalent cardiovascular diseases (1). The most common symptom is IC, defined as a cramping leg pain that occurs during walking and is relieved by a short period of rest. Patients with IC have diminished walking capacity, restricted activity and mobility and reduced health-related quality of life. It leads to social isolation and worsening of the disease with the risk of cardiovascular morbidity and mortality (2). Many patients with IC are not motivated for lifestyle changes (3-5). Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training (6). The aim of the trial is to investigate the effects of a cross-sectoral exercise and lifestyle intervention based on the established cardiac rehabilitation program versus usual care without rehabilitation in patients with IC. The effects, benefits and motivational factors of conservative management will be examined and patient experiences of the intervention, including factors that support or hinder adherence to the intervention explored. The primary hypothesis is that a specialized rehabilitation program for patients with intermittent claudication improves maximum walking distance at Treadmill Walking Test in the intervention group compared with the control group after the completed intervention. The secondary hypothesis is that pain-free walking distance at Treadmill Walking Test improves in the intervention group compared with the control group after 6 and 12 months. Exploratory analyses will test the hypotheses that IC rehabilitation improves quality of life, diet, smoking, alcohol, physical activity and reduces anxiety and depression after 6 and 12 months. Methods: Based on sample size calculation, 118 patients offered conservative management for IC will be included in the trial. The trial is a cross-sectorial Mixed Method design with 1:1 individual randomization to either the intervention or control group. Patients in the intervention group will receive a pedometer and be asked to self-report walking in a logbook. The intervention consists of a 12-week exercise programme provided by physiotherapists, specialized nurse, clinical dietician and personalized motivational follow-up text messages. A qualitative postintervention study will explore experiences of the intervention consisting surveys with open ended questions, brief interview and focus group interview. Results: Inclusion was initiated in December 2017 and is expected to be completed in May 2019. The inclusion rate is carefully monitored. End of 12-month follow-up of all patients will be in May 2020. Result of the study are expected in October 2020. Conclusion: The Study will provide evidence on rehabilitation needs of patients treated conservatively for IC. Point out recommendations for a specialised IC rehabilitation programme, which healthcare professionals and policymakers may use to make qualified, evidence-based decisions in everyday clinical practice and as a foundation for national and international guidelines. Disclosure: Nothing to disclose