Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in absolute walking distance
研究概览
简要总结
Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing.
During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.
RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.
详细描述
Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust.
Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial.
Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups.
With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium).
The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent assessment of absolute walking distance and QoL.
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
- •Arterial claudication with ABPI <0.9 or post-treadmill pressure drop of >20mmHg
- •Able to walk 50 metres unaided
- •Willing to try and give up smoking
- •Willing to take antiplatelet, rivaroxaban and statin
- •Has a smartphone or pedometer or watch
- •Has an email account
- •Adult > 18 years old
- •Able to give informed consent
排除标准
- •Nocturnal foot pain or tissue loss
- •Use of walking stick, frame or wheelchair
- •Severe COPD or heart failure or arthritis
- •Home oxygen
- •Major amputation and non-limb wearer
- •Severe hearing or visual impairment
- •Prior failed exercise regime
- •Prior falls
- •Cognitive impairment
- •Unable to work due to severity of claudication
研究组 & 干预措施
Remotely supervised exercise
Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD.
Intervention = electronic walking log and fortnightly video/telephone call with physiotherapist for 3 months.
干预措施: Remotely supervised exercise programme (Behavioral)
Self-directed exercise
Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD.
Control = electronic walking log and instructions to exercise 4 times per week for 3 months
干预措施: Self-directed exercise (Behavioral)
结局指标
主要结局
Change in absolute walking distance
时间窗: 3 and 6 months post randomisation
Indoor flat surface walking distance until leg pain stops patient walking.
次要结局
- Adherence(1, 2 and 3 months)
- Unplanned revascularisation(6 months)
- Patient satisfaction(3 months)
- Change in disease specific quality of life(3 and 6 months post randomisation)