Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in 6-minute walk test (6MWT) distance completed
研究概览
简要总结
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).
详细描述
Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable intermittent claudication
- •Able to give informed consent
- •Age 18-89 years
- •And one of the following:
- •ABI < 0.9 after 10 minutes of rest OR
- •For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.
排除标准
- •Life-threatening process including:
- •Critical limb ischemia (Rutherford class 4-6)
- •Unstable angina
- •Active malignancy with life expectancy < 6 months
- •Severe NYHA Class IV heart failure
- •Condition other than PAD that limits walking before claudication onset
- •This includes, but is not limited to:
- •Severe angina or dyspnea
- •Arthritis
- •Muscle weakness/pain
- •Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation
- •Inability to attend study visits
结局指标
主要结局
Change in 6-minute walk test (6MWT) distance completed
时间窗: Immediately before and after the 12-week period
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
次要结局
- Change in claudication onset time during 6MWT(Immediately before and after the 12-week period)
- Change in Physical Health Composite Score of SF-36(Immediately before and after the 12-week period)
- Change in ankle-brachial pressure index (ABPI)(Immediately before and after the 12-week period)
- Mortality(Over the 12-week study period)
- Change in Walking Impairment Questionnaire (WIQ) score(Immediately before and after the 12-week period)
- Change in number of steps/week(Immediately before and after the 12-week period)
- Exercise-Related Injury(Over the 12-week study period)
- Critical Limb Ischemia(Over the 12-week study period)
- Other Cardiovascular Outcomes(Over the 12-week study period)
研究者
Amit J. Shah
Assistant Professor
Emory University