Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 160
- 主要终点
- Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
研究概览
简要总结
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:
Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).
Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle-brachial index (ABI) ≤ 0.9 in one or two legs
- •Fontaine stage II of PAD
- •Body mass index <35 kg/m2
- •Resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg
- •Ability to walk at least 2min at 3.2 km/h
- •Ability to undertake an incremental treadmill test
- •Decrease of at least 15% in ABI after a maximal treadmill test
- •Not currently engaging in any regular exercise program
排除标准
- •Exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
- •Cardiovascular autonomic neuropathy
- •Use of beta-blocker
- •Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy
研究组 & 干预措施
No intervention
160 men and women with PAD will be recruited.
干预措施: Control session (Other)
No intervention
160 men and women with PAD will be recruited.
干预措施: No intervention (Observational study) (Other)
No intervention
160 men and women with PAD will be recruited.
干预措施: Exercise session (Other)
Control session
40 patients (men and women) will complete this session.
干预措施: Control session (Other)
Exercise session
40 patients (men and women) will complete this session.
干预措施: Exercise session (Other)
结局指标
主要结局
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
时间窗: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Gender-specific differences in walk capacity in patients with peripheral artery disease
时间窗: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1). Patients will perform a maximal exercise test to determine claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test.
Gender-specific differences in functional capacity in patients with peripheral artery disease
时间窗: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be obtained.
次要结局
- Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test(Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.)
- Gender-specific differences in autonomic modulation at rest and after a maximal exercise test(Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.)
- Gender-specific differences in physical activity level measured by accelerometer(Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.)