The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the Mean Daily Walking Distance Over 7 Consecutive Days
研究概览
简要总结
Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits patients' walking ability and quality of life. For patients with PAD, home exercise programs can improve walking ability and quality of life. In many patient populations, walking more than 5,000 steps a day is associated with better health. Currently, the benefit of walking more than 5,000 steps a day in patients with PAD has not been well studied.
The purpose of this clinical trial is to compare two different home exercise programs in patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs. walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for PAD). This study has the potential to demonstrate that, with the help of fitness monitors, walking at least 5,000 steps a day can improve walking ability and quality of life for patients with PAD.
详细描述
Peripheral artery disease (PAD) is the third leading cause of cardiovascular morbidity, following coronary artery disease and stroke. Symptoms of PAD include claudication, decreased exercise capacity, progressive functional impairment, and decreased quality of life. Structured exercise therapy is a cornerstone of treating symptomatic PAD. Guidelines recommend a symptom-based exercise program that uses claudication to moderate walking sessions.
Home exercise programs have demonstrated efficacy in improving walking ability and quality of life for symptomatic PAD patients. In the general population and patients with certain chronic diseases, walking more than 5,000 steps a day has been associated with better health. The efficacy of walking more than 5,000 steps a day has not been well studied in symptomatic PAD patients.
The EASY FIT Trial is a single-center prospective randomized controlled trial comparing the effectiveness of a daily step-based exercise program (walking at least 5,000 steps a day) vs. a guideline-recommended symptom-based exercise program (walking 45 consecutive minutes for 3 to 5 days a week), on improving walking ability and quality of life in patients with symptomatic PAD. The study will enroll and randomize 40 patients with symptomatic PAD (20 to each exercise program).The results of this study have the potential to create an effective, safe, feasible, and sustainable exercise program that can help PAD patients have greater walking ability and better quality of life.
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
- None
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
- •Male or female, age 18 years or older
- •Diagnosis of lower extremity PAD based on at least 1 of the following criteria:
- •Ankle-brachial index (ABI) of 0.9 or less in one or both legs
- •Invasive angiography demonstrating obstructive lower extremity artery disease
- •Endovascular or surgical revascularization of lower extremity artery
- •Symptomatic lower extremity PAD, characterized by 1 of the following:
- •Fontaine Stage IIa: intermittent claudication after walking > 200 meters
- •Fontaine Stage IIb: intermittent claudication after walking < 200 meters
- •Have the availability of a suitable environment in which to walk
- •Have a mobile phone with WiFi and Bluetooth capability
- •Have the ability to read and speak the English language
排除标准
- •Wheelchair bound
- •Use of a walking aid (ie. cane, crutches, walker, motorized chair)
- •Below or above the knee amputation
- •Leg pain at rest
- •Acute or critical limb ischemia
- •Ischemic ulceration or gangrene
- •Diabetes mellitus complicated by neuropathy
- •Walking impairment due to another cause than PAD
- •Ongoing evaluation for coronary artery disease (ie. awaiting a stress test or cardiac catheterization)
- •Active coronary artery disease requiring the initiation or uptitration of an anti-anginal medication
- •Angina with Canadian Cardiovascular Society (CCS) class 3-4 symptoms
- •Myocardial infarction in the last 3 months
- •Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
- •Congestive heart failure with New York Heart Association (NYHA) class 3-4 symptoms
- •Active arrhythmia requiring the initiation or uptitration of an anti-arrhythmic medication
- •Severe valve disease
- •Active cancer or malignancy (not in remission)
- •End-stage renal disease requiring hemodialysis or peritoneal dialysis
- •Advanced liver disease, defined as cirrhosis
- •Thyroid disease with abnormal TSH in the past 3 months
- •Severe cognitive dysfunction, defined as dementia
结局指标
主要结局
Change in the Mean Daily Walking Distance Over 7 Consecutive Days
时间窗: Baseline, Month 3
At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.
次要结局
- Change in the Peripheral Artery Questionnaire (PAQ) Summary Score(Baseline, Month 3)
- Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score(Baseline, Month 3)