Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Short Form-36 Health Survey (SF-36)
研究概览
简要总结
Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.
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)
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
- •Subjects with PAD in grade IIa (Leriche-Fontaine Classification).
排除标准
- •Subjects with dementia.
- •Institutionalized Subjects in social health centers.
- •Subjects with recent major surgery in the last year or lower limb amputations.
- •Subjects with revascularization surgery of the lower extremities.
研究组 & 干预措施
Intermittent treadmill walking exercise and moderate intensity functional training
Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training.
干预措施: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training (Other)
Intermittent treadmill walking exercise
Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise.
干预措施: Supervised exercise therapy: intermittent treadmill walking exercise (Other)
结局指标
主要结局
Short Form-36 Health Survey (SF-36)
时间窗: 0 weeks, 6 weeks and 12 weeks.
Changes in the eight domains of health status.
Six-Minute Walk Test
时间窗: 0 weeks, 6 weeks and 12 weeks.
Changes in maximum walking distance (MWD) and claudication onset distance (COD).
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
时间窗: 0 weeks, 6 weeks and 12 weeks.
Changes in total punctuation of questionnaire.
Moderate intensity functional training Test
时间窗: 0 weeks, 6 weeks and 12 weeks.
Changes in number of rounds/repetitions and total workload.
次要结局
- Biochemical analysis(0 weeks, 6 weeks and 12 weeks.)
- Hemodynamic measurements(0 weeks, 6 weeks and 12 weeks.)