Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID): Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Absolute Claudication Distance (ACD) in Meters From Baseline
研究概览
简要总结
Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise and physical activity (PA) are central to the management of PAD and help to improve walking distances and reduce the risks associated with PAD such as heart attack and stroke. However, exercise and PA in this population is often limited due to pain. Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase walking distance in patients with PAD. Investigators have also shown that educating patients about their condition and helping them to set goals has the potential to increase PA, and quality of life. This study will examine the feasibility of designing a definitive trial that investigates whether TENS can improve the physical activity of patients with PAD when delivered alone and/or alongside a patient education programme.
详细描述
Peripheral Arterial disease (PAD) affects 2.7 million people in the United Kingdom (UK). The most common symptom that patients experience is Intermittent Claudication (IC), which is pain in the buttock, calf or thigh precipitated by exercise and relieved by rest. The underlying cause of PAD is atherosclerosis, which leads to arterial stenosis, inadequate blood flow and build-up of lactic acid during exercise. Patients with IC have impaired quality of life due to reduced physical capacity. Furthermore, due to the diffuse nature of atherosclerosis and the involvement of other arterial beds, they have 3-4 times increased mortality compared to age and sex matched controls.
Patients with symptomatic PAD should receive the same secondary prevention management as patients with symptomatic coronary artery disease. Improving daily physical activity (PA) is particularly important in individuals with IC as lower PA levels have been recognised as a strong predictor of increased morbidity and mortality in this population. Current National Institute for Health and Care Excellence (NICE) guidelines recommend the use of supervised exercise programmes (SEPs), encouraging patients "to exercise to the point of maximal pain", as first line treatment. SEPs has been shown to be cost-effective when compared to other treatment options such as endovascular intervention and surgical revascularisation. However, while systematic reviews show that SEPs lead to a significant improvement in the absolute walking distances of patients with IC on a treadmill, it is unclear if this is sustained or leads to improvement in daily PA. Furthermore, due to the considerable extra resources required to deliver the recommended 3 months exercise programme (30-45 minutes 3x weekly), SEPs are not always routinely available to National Health Service (NHS) patients, and time and travel costs tend to lead to low patient uptake and high attrition rates. Therefore, investigating the feasibility of using low-cost, patient-centred interventions that can support increased PA is warranted.
Lack of self-efficacy, attributed to poor understanding of the disease and uncertainty regarding the importance of exercise, has been shown to be a major barrier to exercise uptake in this population. Educating patients with IC about their disease pathology and the benefits of walking is key to enhancing success of secondary prevention strategies for people with IC. Investigators recently piloted a structured, patient-centred education intervention (SEDRIC) with the specific aim of educating patients with IC about their condition, improving patient ownership, and promoting self-managed walking. In addition to improved treadmill walking distances, investigators found out that there was a trend for patients to increase their daily PA.
For patients with IC to gain benefits of secondary prevention, exercising beyond the point when pain occurs is recommended, representing another barrier to engagement in PA. Despite this, investigators' systematic review found that pain management as a route to facilitate exercise and PA has rarely been explored. Recent interest has focused on the use of TENS (a low-cost, non-invasive pain management device) to improve angiogenesis, muscle function, pain and walking distances in patients with IC. TENS has a strong placebo effect in pain conditions, and testing effectiveness against placebo is advocated. In a proof-of-concept pilot study, Investigators demonstrated that TENS could significantly improve pain and increase treadmill walking distances above placebo levels. Our exploratory study also established that home use of TENS was both acceptable and provided self-reported improvement in PA in individuals with IC.
Although patient-centred education (SEDRIC) and TENS have both demonstrated potential to improve daily PA in people with IC, the use of these components in combination has not previously been evaluated. Investigators therefore propose a 2 x 2 (TENS versus placebo TENS x SEDRIC versus no additional education) feasibility Randomised Controlled Trial (RCT) that will compare use of TENS against placebo TENS with and without a patient-centred education programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Primary outcome assessors will be blinded for patient group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting Ankle Brachial Pressure Index (ABPI) <0.9 in at least one leg
- •Stable IC for ≥3 months
- •Walking limited primarily by claudication
- •Able to exercise on a treadmill
- •Able to read and speak English to a level allowing satisfactory completion of the study procedures
- •Able to provide written informed consent for participation
排除标准
- •Planned surgical or endovascular intervention for PAD within the next 3 months
- •Critical limb ischaemia
- •The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
- •Previous experience of using TENS/ structured patient education for PAD
- •Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently.
- •Patients who require walking aids including artificial limbs
- •Major surgery, myocardial infarction or stroke/ Transient Ischaemic Attack (TIA) in the previous 6 months
- •Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis)
- •>20% variation in baseline ACD on treadmill
- •Severe peripheral neuropathies above the ankle.
- •Participation in another research protocol
结局指标
主要结局
Change in Absolute Claudication Distance (ACD) in Meters From Baseline
时间窗: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Maximal walking distance on graded treadmill test
Participant Retention Rate
时间窗: End of study (18 weeks)
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Recruitment Rates
时间窗: Recruitment
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Adverse Events
时间窗: End of study (18 weeks)
Record defined adverse events in all groups
Uptake of Interventions
时间窗: End of study (18 weeks)
Measure uptake of intervention via log of TENS use and attendance at education session and follow up phone calls
次要结局
- Visual Analogue Scale (VAS)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Geriatric Depression Scale (Short Form) (GDS-SF)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Intermittent Claudication Questionnaire (ICQ)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Change in Initial Claudication Distance (ICD) in Meters From Baseline(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Change in Daily Number of Steps(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Change in Total Number of Upright Events Per Day(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Change in Total Number of Walking Events Per Day(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Change in Event-based Claudication Index(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Intermittent Claudication Questionnaire (ICQ)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Short-Form 36 Questionnaire- Physical Component(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- McGill Pain Questionnaire (MPQ) Pain Rating Index (PRI)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Visual Analogue Scale (VAS)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Brief Illness Perception Questionnaire (IPQ)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Geriatric Depression Scale (Short Form) (GDS-SF)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 6 weeks (post-intervention), 18 weeks (follow-up))
- SF-36 Mental Component Score(Baseline, end of intervention and follow-up)