Promoting Walking in African Americans With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change from baseline to eight weeks in 6 minute walk test
研究概览
简要总结
The investigators are conducting a pilot study for a clinical research trial to establish the feasibility and acceptability of the intervention and the most effective recruitment strategies prior to the full study.
详细描述
The eight week pilot will be conducted to establish the feasibility of implementing motivational interviewing as a means to counsel African Americans with peripheral arterial disease (PAD) to increase their walking. Additionally, we will determine the acceptance of culturally sensitive print material on managing PAD. Finally, we will utilize the pilot to develop best practice methods for successfully carrying out the full study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •African American (determined by self-report)
- •Lived most of their life in the United States
- •Resting ABI <0.95
- •English Speaking
- •Has a telephone
排除标准
- •Currently walking for exercise at least 5 days per week (i.e., a PACE score ranging from 5-8)
- •Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
- •Rest pain with ABI <0.4 and non-palpable femoral pulses without prior evaluation by a vascular surgeon, given the need for evaluation for the role of more invasive therapy prior to recommending walking therapy
- •Leg revascularization within 3 months of enrollment or plans for revascularization during the study period
- •Use of supplemental oxygen
- •Myocardial infarction within the preceding 3 months
- •Resting blood pressure > 200/110 mmHg
- •Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression > 2.0 mm
- •Inability to walk for 2 minutes; the rationale being that people who cannot walk for 2 minutes would not be able to complete the necessary submaximal treadmill test, which is used to screen for coronary ischemic symptoms. We will also exclude anyone who can walk for 20 minutes or more during the submaximal treadmill test. Anyone who can complete the submaximal test would not have significant walking impairment and would not get that much out of the study.
- •Short Physical Performance Battery score of 10 or higher as such persons do not have a clinically significant impairment in mobility; therefore, we will exclude anyone who scores a 10 or higher (out of a maximum of 12 points).
结局指标
主要结局
Change from baseline to eight weeks in 6 minute walk test
时间窗: 8 weeks
The participant will walk as far as possible for 6 minutes in a marked corridor. They will be permitted to slow down, stop, and to rest as necessary, but the time will continue to run. They will be given standardized encouragement at each minute and their ending point will be marked with tape. The laps will be counted and the total distance in feet will be recorded. The onset of claudication, number of times the participant needed to stop, and rate of perceived exertion will be recorded throughout the test.
次要结局
- Baseline six minute walk test(baseline)
- Baseline 7 day physical activity(baseline)
- Change from baseline to eight weeks 7 day physical activity(8 weeks)
研究者
Tracie Collins, MD, MPH
Preventive Medicine and Public Health Chair
University of Kansas Medical Center